With Q3 earnings behind us, we shift the lens from 'who is making money' to 'which modalities are incubating the next wave of CDMO orders.' This piece takes stock—across peptides, gene editing, nucleic acids and bispecific/multispecific antibodies—of the dig-able trends, capacity levels and the hard data points we consider most important, with a CDMO-oriented cross-modality conclusion.
At Ledu Life Science Park in Shanghai's Baoshan district, six 15,000-litre bioreactors — 90,000 litres of biologics capacity in total — have sat idle for more than two years, and the company's biologics subsidiary entered court-administered bankruptcy liquidation in December 2025. Ledu had once pitched a 1.3-million-litre capacity target in 2021, within reach of Samsung Biologics' 2032 plan. Meanwhile the capital has not left: vector-focused CDMOs — Yinuo, PackGene, Jinfan — closed consecutive nine-figure-yuan rounds within a year. The old moat has become an entry ticket, and next-generation delivery vectors are the new scarcity story.
Mutual fund Q3 2026 filings are in: healthcare fund weighting in pharma rose to 10.3% (+3.6 points quarter-on-quarter), and medical R&D outsourcing was the standout — up 7.14 points in pharma funds and 11.75 points in non-pharma funds, the largest increase of any subsector, with WuXi AppTec ranking first on both value and fund count in both cohorts. Yet the sector's PE percentile has fallen from above 70% in September to about 45%, and guidance upgrades have not stuck in the share price. Positions and policy are now racing: 15 November, 7 December and 18 December will decide whether this crowded trade is confirmed.
Peptides, ADCs and CGT have been pitched as the 'second growth curve' of CDMO for three years. The 2026 Q3 reports hand the microphone back to the financials: WuXi's TIDES booked RMB 11.52bn in 9M, WuXi XDC posted RMB 3.70bn in H1 with orders +50-62%, while Hoyuan and Porton's CGT revenues together are under RMB 0.3bn and still loss-making. Who is booking real revenue, and who is still drawing on the whiteboard?
With the Q3 earnings season closed, the two pure-play global benchmarks - Samsung Biologics and Lonza - sit alongside China's four (WuXi AppTec, WuXi Biologics, Pharmaron, Asymchem). Three rulers - growth gap, real order flow, and the 232 tariff - show China's supply chain was not dismantled by the tariff.
Hidden in the Q3 reports is a harder signal than revenue - capital expenditure. Six CDMOs' 2026 capex totals over RMB 20 bn and is still climbing into 2027. This piece decodes what they are building, where the inflection lies, and the risks.
GenScript partnered with Lilly's AI drug-discovery collaboration platform Lilly TuneLab in September, providing wet-lab services — protein expression, purification and characterisation — to platform members. Its 30 October investor day revealed the numbers that matter: revenue from a single research site of a global top-20 pharma grew 5x year on year in H1, AIDD S2D (sequence-to-data) services rose from 23% to 64% of that client's revenue mix, and candidate molecules awaiting validation per round jumped from hundreds to 1,000-5,000. AI-native clients are not just adding orders — they are changing the pricing structure.
With Q3 filings now in, China's CXO sector has delivered an uneven scorecard: WuXi AppTec's chemistry revenue grew 51.52%, Medicilon turned profitable and JOINN Laboratories posted a profit jump of more than 10x, while Asymchem's non-IFRS net profit grew just 0.04% and Jiuzhou Pharma declined on both lines. The unifying explanation: demand recovers in a gradient from preclinical to downstream, fuelled by the US biotech IPO reopening, BD upfront payments flowing back, and AI-native wet-lab orders. The recovery is real — but each segment's pay-off point differs.
US CDMO giant Curia announced on 27 October a USD 28 million expansion of sterile API manufacturing at its Valladolid, Spain site, completing in Q4 2028 with new steroid and non-steroid capabilities and integrated aseptic crystallisation, milling and micronisation. The investment follows a USD 4 million aseptic-suite upgrade in May and a USD 200 million sterile drug-product expansion in New Mexico. While the industry's attention is fixed on biologics litres and peptide tonnes, Western CDMOs' capex is quietly converging on 'sterile + high-potency + complex formulations'.
On 2 November 2026, Germany's Fresenius signed an exclusive development agreement with WuXi Biologics: exclusive options on up to 37 potential first-launch biosimilar candidates over ten years, expanding its pipeline from 29 to as many as 66 molecules across 13 therapeutic areas with more than 370 billion euros of originator list-price sales behind them — what the company calls the largest biosimilar development agreement ever announced. The structure is pure fee-for-service: no upfront, no fixed milestones, with all commercialisation rights and profits staying with Fresenius. One contract turns biosimilar outsourcing from single-asset deals into a portfolio of options.
While China's CXDMOs win downstream orders, who makes the tools? A Q3/H1 read on seven upstream names - equipment duopoly (Tofflon, Truking), EPC (Morimatsu), resins & media (Nanomicro, OPM Biosolutions), reagents (ACROBiosystems, Sino Biological) - three tiers of localization, at different speeds.
In its IPO prospectus, Anthropic framed the USD 2 trillion drug market as AI's next frontier, and on 27 October disclosed the acquisition of Mithril Medicine — an AI drug company with exactly one full-time employee. Its 'Pipeline-in-a-Person' model used Claude to coordinate 11 external labs and advanced a rare muscular-dystrophy candidate to mouse studies in under 18 months. The tell is buried in its 38-page technical report: CRO appears 58 times, AI/Claude only 47. The stronger AI gets, the tighter wet-lab capacity becomes. In China's Q3 reports, WuXi AppTec mentioned AIDD/AI4S for the first time, Pharmaron flagged AI-native clients, and GenScript's AIDD revenue grew 105% in H1.
From 5 to 10 November, the 9th China International Import Expo opens in Shanghai: 4,142 overseas exhibitors, exhibition space above 440,000 sqm for the first time, and a record 480-plus launches in the medical devices and pharmaceutical halls. Two bellwether shifts define this edition: multinationals are putting unapproved pipelines on stage (Novartis's Ianalumab makes its global public debut), and Chinese R&D is being exported by MNCs (Sanofi partnering with Sino-Pacific's rovadicitinib programme for rare blood disorders). As China moves from end market to innovation source, Chinese CXDMOs shift from 'taking on capacity' to 'the starting point of global pipelines'.
According to Korean biotech media on 31 October, Samsung's biotech business is shifting from CDMO toward a 'precision medicine ecosystem' combining IT, genomic data and diagnostic AI: Samsung Electronics put an additional USD 175 million into Element Biosciences in June to become its largest shareholder, backing a platform that cuts whole-genome analysis to about USD 100 per person; with Sonio (AI prenatal diagnostics) and Xealth (a digital-health gateway into 500-plus US hospitals), the endpoint is 'connected care' linking wearable biometrics with hospital genomics. After topping global capacity, Samsung is building a data moat.
A cross-company read of the four domestic CXDMO players (WuXi AppTec, Asymchem, Pharmaron, Porton) and two global leaders (Samsung Biologics, Lonza) across 2026 Q3/9M - growth is back, but profit quality and order books separate the field.
The US BIOSECURE Act requires the Office of Management and Budget to publish its first list of Biotechnology Companies of Concern (BCC) by 18 December 2026. As of 31 October the list has not appeared, leaving 48 days on the clock. Enacted on 18 December 2025 as part of the FY2026 NDAA, the law replaced naming five Chinese companies outright with a recurring list mechanism and a two-and-a-half to three-year phased implementation. WuXi AppTec was added to the Section 1260H list in June, sued, and won a preliminary injunction; on its 27 October call management said it had received no OMB notice but acknowledged it could still be designated through an independent review. This piece maps the statute, the two designation routes, the actual scope of the restriction, and three indicators worth tracking.
On 29 October Cambrex broke ground on a $120m expansion at its Charles City, Iowa site, adding 160,000 litres of capacity, lifting the site's total volume by roughly 25% to nearly one million litres, with completion slated for Q4 2028 for small-molecule APIs and synthetic peptides. Against the March feasibility-study language of 140,000 litres and a 20% gain in large-scale capacity, the project grew about 14% in eight months. The more interesting detail is the route: the announcement specifies commercial-scale liquid-phase peptide manufacturing, a deliberate mismatch with a global peptide build-out dominated by solid-phase. US-sited capacity also carries a country-of-origin credential under Section 232 tariffs.
PharmaBlock (300725) reported first-nine-month 2026 revenue of RMB 1.634bn (+15.16%), net profit of RMB 151m (+33.36%) and adjusted net profit of RMB 128m (+44.87%), with gross margin at 32.93% (+1.98pp) and CDMO backlog up more than 20% year on year. The split is the story: domestic customer revenue reached RMB 549m (+31.41%) while overseas revenue grew 8.07% to RMB 1.077bn. For a company built on selling building blocks to overseas pharma discovery teams, 2026's incremental growth came from China. New-modality revenue was RMB 152m; the Zhejiang Huishi peptide GMP pilot plant started up in June and is ramping, and liquid-phase peptide capability is under construction.
Lilly reported Q3 2026 revenue of $24.397bn (+39% YoY) and $67.170bn for the first nine months (+46%). Tirzepatide (Mounjaro plus Zepbound) contributed $43.768bn, or 65% of total revenue; full-year guidance was raised from $85–87bn to $91–92bn, and the stock jumped 7.51% intraday, making Lilly the first pharmaceutical company to cross a $1.3trn market cap. Yet orforglipron (Foundayo), the oral small-molecule GLP-1 approved in April, booked only $184m in Q3 against expectations near $229m. A slower oral substitution curve extends the injectable franchise — and with it the payback window on peptide API and solid-phase synthesis capacity.
Tigermed reported nine-month 2026 revenue of RMB 5.792bn (+15.23%) but a net loss attributable to shareholders of RMB 272m, versus a RMB 1.02bn profit a year earlier. Adjusted net profit, however, rose 38.08% to RMB 450m — already above the RMB 355m booked for the whole of 2025. The gap is investment: fair-value changes of -RMB 597m (versus +RMB 323m) and investment income of RMB 29m (versus RMB 440m) together swung profit by more than RMB 1.3bn. Tigermed holds RMB 9.698bn of other non-current financial assets and RMB 4.625bn of long-term equity investments — RMB 14.323bn, or 51.2% of total assets. The real operating signal sits in contract liabilities: RMB 1.436bn at period end, up 33.10% from the start of the year.
On the evening of 29 October, Jointown Pharmaceutical (600998) announced a four-party strategic cooperation agreement with JOINN Laboratories (603127.SH / 06127.HK), JOINN Biologics and Sheng Tong Intelligence, covering commissioned R&D, market access and sales, early-stage incubation, AI for healthcare, and industrial park development. Jointown frames it as a new 'CRO + CDMO + CSO' integrated model, with the explicit aim of securing sales and distribution rights for quality innovative and high-end generic drugs by entering early-stage development. It mirrors the WuXi and Pharmaron route: one walks from the lab toward commercialisation, the other reverses in from the channel.
On the evening of 28 October 2026, JOINN Laboratories (603127.SH / 06127.HK) reported nine-month revenue of RMB 1.188B (+20.60%) and net profit of RMB 930M (+1051.94%), with Q3 revenue of RMB 484M (+53.01%). The order book matters more: cumulative new bookings of about RMB 3.42B (+109%), including RMB 1.4B in Q3 alone (+126%), and a backlog of about RMB 4.5B (+80%). As the front end of the R&D spending chain, preclinical safety evaluation is flashing a clear recovery signal — the last link in the industry's transmission chain to turn.
On the evening of 28 October 2026, Heyuan Biopharma (688238.SH) reported Q3 revenue of RMB 84.7M (+40.04%) with losses narrowing by RMB 12.9M year on year; nine-month new CDMO bookings exceeded RMB 230M, and the company has helped clients secure 78 China-US IND approvals to date. The milestone sits in licensing: in July 2026 the company obtained a Class C Drug Manufacturing Licence from the Shanghai medical products regulator, becoming one of very few domestic providers with both scaled CGT capacity and licensed commercial contract manufacturing. With Announcement No. 48 proposing to ban the export of CGT process platforms, this has become a purely domestic-closed-loop business.
Lonza leadership has confirmed that bioconjugation is a gap in its US capacity network and a potential area of investment. Its ADC footprint is Swiss-centred: multipurpose, high-potency payload-linker suites at Visp are scheduled to begin ramping in 2029, and a second commercial aseptic ADC filling line at Stein is expected to operate in 2030; management says the company is involved in more than half of the commercial ADC products on the market. With ADCs sitting on the Section 232 exemption list but 'origin' logic growing ever more important, the scarcity of US-based ADC conjugation capacity is a blank space worth marking on the global outsourcing map.
On 21 October, Spain's ESTEVE CDMO said it would invest more than USD 80M to relocate, expand and modernise its Shaoxing site: three workshops, 250 m3 of reaction volume, 150 m3 reserved, expandable past 400 m3. In the same month, Boehringer Ingelheim's 6,000-litre Zhangjiang biologics plant went to Shanghai RAAS for a nominal RMB 1 base price and no more than RMB 20M - a site that cost over EUR 70M in 2017, lost RMB 73.3M in 2024 and RMB 259.3M in 2025. Between the two lies one question: in China, which capacity is still worth paying for.
In October, Haoyuan Pharma began phase two of its Chongqing antibody-drug conjugate CDMO site, and the site's first project formally entered US FDA clinical filing. The 85-mu site, commissioned in March 2025 and already through an EU QP audit, runs antibody drug substance, high-potency payload, conjugation and sterile fill-finish under one roof. First-half revenue was RMB 1.648B (+25.71%) with back-end backlog above RMB 1B (+72.6%), yet 2025 gross margin on back-end APIs and intermediates was only 13.6% against 61.9% on front-end building blocks. ADC integration is a chemistry exam and a heavy-asset exam.
Piramal Pharma reported Q2 FY27 (July-September 2026): revenue of INR 26.17B, up 28%; CDMO revenue INR 14.24B, up 36%; EBITDA INR 3.85B, up 72%, margin 14.7% (+370bp); the quarter swung to a net profit. In the first half it added 22 new customers, hosted 110 customer audits and 12 regulatory inspections with zero FDA OAI classifications. Phase III molecules rose from 25 to 28; ADC revenue grew 51%. Full-year guidance was raised to 19-20% growth.
Pharmaron's Q3 2026 report (filed the evening of 27 October): third-quarter revenue of RMB 4.408B, up 20.94%, and net profit attributable to shareholders of RMB 497M, up 13.06%. Nine-month revenue was RMB 12.003B (+19.01%) with net profit of RMB 1.247B (+9.31%). Profit is trailing revenue, and the gap says gross margin is still in repair. Orders, though, have already moved: nine-month new signings grew more than 30%, with CDMO up over 40% and laboratory services and clinical research each above 25% - a textbook mid-cycle recovery report in which orders lead and margins follow.
Xue Yingzhou, just appointed President of Jiuzhou Pharmaceutical, spent the first half of his career at Novartis rising to production director, supply-chain director and technical-service director; after Jiuzhou acquired Suzhou Novartis for about RMB 790M in 2019, he moved with the plant and ran its core subsidiary Ruibo Suzhou for seven years. Executive VP Cai Wanyu, appointed in the same batch, brings nearly 40 years of manufacturing management. The message is industry-wide: buying MNC assets in China is lesson one; internalising the acquirer's operating DNA is lesson two — the one that decides customer concentration and commercial-order execution.
9M total revenue RMB 45.54B and attributable net profit RMB 19.40B (+60.6%); adjusted non-IFRS net profit RMB 18.38B (+74.4%). Continuing-operations backlog crossed RMB 70B for the first time at RMB 76.74B, and the company raised full-year guidance again.
As the 2026 third-quarter reporting season closes, the four A-share CDMO leaders - WuXi AppTec, Porton, Asymchem and Pharmaron - show a sector back in growth but with divergence widening: top-line expansion returned to double digits, yet growth rates span +9% to +38.6%, and differences in earnings quality and business mix matter more than scale.
On 22 October the US Treasury published a notice of proposed rulemaking under the COINS Act that adds biotechnology as the sixth controlled technology sector — and the only one the Treasury added on its own authority. Drug compounds, biomanufacturing equipment and facilities, biological design and sequencing, brain-computer interfaces, bioinformatics tools, flow cytometers and LC-MS systems would be prohibited. Conventional in-licensing agreements paid in cash without equity, and fee-for-service R&D collaborations, are explicitly carved out. Comments run to 7 December; a final rule is targeted before 13 March 2027.
On 22 October Gilead agreed to pay USD 1.275 billion in cash upfront (about RMB 8.5 billion) for Shanghai-based PepStar Therapeutics' oral IL-23R inhibitor programme, whose lead asset HCXT-2001 is still in Phase 1. The seller was founded in April 2023 and moved a molecule to a billion-dollar upfront in just over three years. The valuation is only part of the story: if oral macrocyclic peptides work, they open a second volume curve for peptide CDMOs beyond GLP-1.
A regulatory filing disclosed by SK bioscience on 25 October shows 2025 consolidated revenue of KRW 651.4 billion (+143.5%) and an operating loss narrowed to KRW 123.5 billion. Acquired German CDMO IDT Biologika posted H1 2026 revenue of KRW 257.8 billion and operating profit of KRW 127 billion, already above all of 2025. The company targets doubling IDT's revenue by 2028, using an EU HaDEA microneedle patch framework worth up to EUR 225 million and a CEPI-funded Ebola project.
On 29 September 2026 the Section 232 pharmaceutical tariffs exited their grace period and became payable by all importers: patented medicines, their APIs and key starting materials face a 100% base rate, and China sits outside the 19 favoured jurisdictions. The same schedule also hands out zeros — generics, biosimilars, ADCs, cell and gene therapies, plasma-derived therapies and orphan-only drugs are exempt; a committed US onshoring plan buys 20%, and adding an MFN pricing agreement takes it to zero through 20 January 2029. One tariff table splits the CDMO industry into two markets.
Apeloa's Q3 2026 report (22 October): nine-month revenue of RMB 6.835B (-11.97%), net profit RMB 614M (-12.37%) and non-recurring net profit RMB 568M (-12.22%). Yet CDMO revenue reached RMB 2.05B (+21.38%), with Q3 alone at RMB 642M (+40.96%), while API was deliberately shrunk to RMB 4.028B (-22.53%). After the results, 185 institutions met management, which disclosed more than RMB 7.8B of commercial backlog to be delivered within three years and 1,715 total projects (+38%).
At a 23 October investor call with more than 500 attendees (18 institutions filed records), Asymchem addressed capacity line by line: existing peptide capacity will run at high utilisation in 2027 with new build planned; payload-linker capacity is "very tight" and expansion is accelerating; antibody and fusion-protein orders surged in Q3, the site cleared a PAI inspection and enters commercial production in 2027 with a two-year capacity gap; Q3 new orders grew about 30% on a high base, with full-year guidance of 19%–22% unchanged.
9M26 revenue reached RMB 3.94B (-5.38%) and net profit RMB 617M (-17.50%), yet Q3 alone grew 5.58% to RMB 1.36B with net profit up 3.41% to RMB 229M. New small-molecule CDMO projects rose over 25% YoY and TIDES added 20+ projects with a backlog above RMB 5B, while group-wide capacity utilisation sits at just ~70%.
Lonza runs 484,000 L in the US, 219,000 L in Europe and 90,000 L in Singapore — 793,000 L total, roughly two-thirds in America. Samsung Biologics has 784,000 L across Plants 1-5 in Songdo, over 90% in Korea. A 1.1% difference in volume, mirrored geopolitical exposure, and two very different ways to be 'the largest'.
On 19 October Merck KGaA agreed to acquire Silence Therapeutics at USD 20 per ADS in cash — an enterprise value of USD 1.1B and equity value of about USD 1.3B, a 130% premium to the prior close. Lead asset divesiran is a TMPRSS6 siRNA dosed subcutaneously once every three months, with an 88% vs 19% Phase 2 response rate.
Revenue for the first nine months reached RMB 5.395B (+16.52% YoY), with net profit of RMB 852M (+6.49%). Q3 alone delivered RMB 1.788B in revenue (+24.04%) and RMB 332M in net profit (+81.49%). Small-molecule CDMO grew only 3.59%, while emerging businesses rose 50.20% to RMB 1.923B and domestic client revenue climbed 42.83%. Management guides full-year revenue growth of 19%-22%, implying a sharply back-loaded Q4.
ESMO 2026 runs 23-27 October in Madrid with roughly 30 Chinese studies among the late-breaking abstracts - about one third of the total and a record high. China holds five of the twelve Presidential Symposium slots, all Phase III: HutchMed's SAFFRON and Akeso's HARMONi-GI1 both hit PFS and OS, Hansoh's B7-H3 ADC ARTEMIS-011 delivered the first positive Phase III in osteosarcoma in a decade, Kelun-Biotech's TROP2 ADC TroFuse-005 met dual primary endpoints, while KeyMed/Lepu's CLDN18.2 ADC met OS but missed PFS.
On 20 October OpenAI announced the acquisition of Orchestra Bio, a drug development coordination platform whose team and technology will join Rosalind, its life sciences unit. Unlike earlier AI-pharma deals focused on targets and molecule design, Orchestra's agents track programme schedules, trace cross-stage delays and compare response options. As AI moves from design into execution, what gets digitised is CMC, manufacturing batches and supply chains - the most data-dense part of the CXDMO value chain.
Q3 revenue reached KRW 1.4903T (+18.5% YoY), operating profit KRW 640.1B (+1.0%) and net profit KRW 391.1B (-21.2%), with the operating margin falling from 50.4% to 42.9%. Growth came from full utilisation of Plants 1-4, the Plant 5 ramp and the first revenue contribution from Rockville, while three cost items landed at once. Management still raised full-year revenue growth guidance to 20% and holds USD 21.9B in cumulative binding CMO contracts.
Hansoh Pharma announced a platform-level ADC partnership with Roche on 19 October: USD 400M upfront, USD 110M on the one-year anniversary and more than USD 15B in potential milestones, a total exceeding USD 15.5B and the second-largest China out-licensing deal on record. The subject is no longer a single molecule but two preclinical programmes plus multiple Roche-proposed targets developed on Hansoh's own ADC platform. In the same window, METiS partnered with Lilly on an AI-driven extrahepatic LNP platform and Hutchmed closed a USD 110M upfront, while the NDRC reported roughly USD 130B of innovation-drug technology licensing in the first nine months.
A Morgan Stanley note dated 15 October disclosed that WuXi AppTec plans to invest RMB 10.1B to expand WuXi STA's Changzhou site, adding 800 tonnes of API capacity on about 420,000 sqm (630 mu), focused on technical services and process development across six therapeutic areas. Combined with 2026 targets to lift small-molecule reactor capacity from 4,000 to 5,000 cbm and solid-phase peptide synthesis from 100,000 to 130,000 L, the expansion pace now exceeds the original plan and serves as a leading indicator for 2027.
Less than ten days before a planned three-week general strike, the Seoul High Court expanded its injunction from three to all nine core drug-substance manufacturing stages at the Songdo campus, and the union subsequently postponed the October 26 walkout. For the first time, the "unpausable" nature of biologics manufacturing has been written into labor rules via an injunction with financial penalties — and for global clients, the real test remains delivery certainty.
Two quality signals landed on the same day: WuXi Biologics' Wuxi Mashan site passed an FDA unannounced GMP inspection with no major or critical findings, sending the stock up nearly 7% intraday; and WuXi AppTec received Frost & Sullivan's 2026 Global Company of the Year recognition in CRDMO for the tenth consecutive year. In 2026's geopolitical and regulatory climate, verifiable compliance records are turning from a bonus into the admission ticket for order allocation.
On October 13, Zydus Lifesciences and Formycon announced FDA acceptance of the FYB206 BLA — a pembrolizumab (Keytruda) biosimilar and, to the companies' knowledge, the first publicly announced Keytruda biosimilar filing accepted in the US. Developed without a comparative Phase III efficacy trial under a February 2025 FDA agreement, FYB206 could see a decision by Q3 2027. Keytruda posted US$8.4B in Q2 2026 quarterly sales, putting the industry's largest patent cliff on the clock.
C&EN's on-site reporting from CPHI Milan 2026 (October 6–8) shows capacity investment in contract pharma remains hot despite big pharma's insourcing push: SK pharmteco commits US$200M over five years, Flamma buys Lundbeck's Padova API plant, and Agilent's US$725M oligonucleotide program enters phase one in March 2027. On the demand side, Orforglipron captured over 30% of new US oral-obesity patients within months, pushing peptide API demand toward the tens-of-tons scale.
After third-round labor mediation collapsed on October 1, Samsung Biologics' union called a second general strike from October 26 — four times longer than the May walkout that involved about 2,800 employees and cost roughly KRW 150B. The timing collides with the PolyPeptide additional acceptance period (Oct 19–30), an October 26 EGM and Q3 results on October 27. Beyond a first-place 845,000 L footprint and US$22B+ in cumulative orders, 2026 new signings have shifted to incremental add-ons (~US$459M YTD) and the Rockville site still runs near break-even — putting delivery certainty in the spotlight for the world's largest biologics CDMO.
The 2026 ESMO Congress runs October 23–27 in Madrid, with 90+ late-breaking abstracts (LBAs) and 12 core studies in the Presidential Symposium. 28 Chinese studies made the LBA list, five of them in the presidential sessions — roughly a third of the congress's core late-breakers. Paired with dense Q3 disclosures in late October (WuXi AppTec and Samsung Biologics both report October 27) and China out-licensing already past US$120B for the year, the innovation chain enters a data–BD–order catalyst window.
Novo Nordisk said at its Capital Markets Day that it will use CMOs for peptide API synthesis — a major break from its decades-long vertically integrated model. Macquarie estimates that switching from injectable to oral formulation can raise per-patient peptide API demand roughly 73-fold, while Novo targets a tenfold rise in oral Wegovy patients to 15 million by 2030. WuXi AppTec, Samsung Biologics and Divi's Labs are flagged as potential beneficiaries as the peptide CDMO race shifts to a dual contest of cost and delivery certainty.
The global biosimilar market is worth roughly US$40B with potential compound growth near 20% over the next decade. The FDA is advancing two key policy shifts — relaxing comparative efficacy study (CES) requirements while strengthening process characterization and quality control (CMC) standards. The regulatory pivot raises the bar for the whole industry: first-to-launch share could exceed 30% with the top three taking 60–70%, making launch timing the revenue watershed and favoring CMC-strong players such as Henlius and WuXi Biologics.
On October 16, China's Ministry of Commerce and Ministry of Science and Technology released Announcement No. 48 of 2026, opening public consultation on revisions to the Catalog of Technologies Prohibited or Restricted from Export: 5 biopharma technologies are proposed for inclusion, with 'CGT technology process platforms with independent intellectual property rights' listed among prohibited exports. WuXi AppTec shares briefly hit the daily limit down intraday on RMB 12.3B of turnover. The real exposure for CXOs, however, is limited — the items cover only self-owned IP, and out-licensing without ownership transfer qualifies for automatic-license facilitation.
On October 16, Samsung Biologics, through its Swiss subsidiary Samsung Peptide AG, published the definitive interim result of its tender offer for PolyPeptide: 87.59% of issued shares were validly tendered during the main offer period, far above the 66⅔% minimum acceptance condition, and the offer was declared successful. The additional acceptance period runs October 19–30, with completion expected late 2026 or in Q1 2027. The roughly US$1.8B all-cash deal will mark the largest M&A transaction in Korean pharma and biotech history — and confirms peptide capacity as the new battleground of the global CDMO race.
H1 2026 A-share CXO revenue reached RMB 61.6B (+19.6%) with deducted non-net profit +58.2%; CDMO revenue RMB 52.9B (+21.4%) and Q2 growth accelerating to 27.2%. Backlog visibility at top players now spans 2–3 years, and global CXO financing hit US$26.75B (+58.5%) — three forces driving a new R&D and manufacturing expansion cycle.
AI for Science (AI4S) is moving from concept to industrialization and, through the 'dry-wet loop', directly drives demand for CXO and research upstream. Novo Nordisk teams with Anthropic, ByteDance's Anew Labs raises US$290M, and Danaher and Biohub together commit over US$1.8B to AI bio-data infrastructure — AI drug discovery is becoming a third force reshaping CDMO order structure.
At the 2026 World ADC Awards, WuXi XDC won 'Best CDMO' for the fourth consecutive year and retained 'Best CRO' for the second year running — the only CRDMO to hold both titles in consecutive years. From delivery records of '10 months DNA-to-PCC, 15 months DNA-to-IND, 24–36 months late-stage-to-BLA' to its proprietary technology stack (WuXiDARx™, WuXiTecan-2™) and its China + Singapore dual-site network, the certainty of the ADC outsourcing leader keeps compounding.
WuXi AppTec inaugurated a PSD-4 spray drying facility at its Couvet, Switzerland drug-product site, enabling amorphous solid dispersion manufacturing to improve the oral bioavailability of poorly soluble compounds. Together with its Taixing site, it forms a China–Europe dual-site supply chain with EU batch release via Munich QP services.
Three industry developments: Verastem's KRAS G12D inhibitor VS-7375 posted a 50% confirmed ORR in 2L pancreatic cancer; Vir and Gilead struck an up-to-$1.875B PRO-XTEN dual-masked T-cell engager pact; Zealand and Generate Biomedicines signed a near-$1.2B AI protein-drug collaboration.
Arrowhead's ARO-MAPT lowered cerebrospinal-fluid Tau by up to 73% on average (85% max in an individual) in healthy volunteers via subcutaneous injection, crossing the BBB through TfR1 antibody-Fab conjugation. Advances in fat, muscle and lung extrahepatic delivery are expanding the siRNA landscape.
On October 14, Lonza held its Capital Markets Day in Vacaville, California, declaring its pure-play CDMO transformation complete in under two years and upgrading its Organic Growth Model: low-teens (10–13%) organic CER sales growth over time, a mid-term CORE EBITDA margin ambition raised to the high thirties, and ROIC of 2–3x WACC. Q3 2026 performed in line across all platforms and full-year guidance (11–12% CER growth, 33–34% margin) was reiterated.
This month the CDMO sector advanced on three fronts: a capacity & order arms race (Samsung Biologics past $22B, AsymBio's APAC award, WuXi Biologics' global dual-sourcing), portfolio carve-outs (Lonza's pure-play pivot), and technology platformization (induced-proximity drugs, conjugates).
In the first three quarters of 2026, 22 U.S. biotech companies completed IPOs, raising $6.9B — roughly 5x the full-year 2025 total. The article maps the financing trends behind clinical data, differentiated technology and TIDES (peptides/oligonucleotides).
In Q3 2026, the FDA approved two induced-proximity drugs using different mechanisms — BMS's CELMoD iberdomide and Revolution Medicines' RAS molecular glue daraxonrasib — while non-degrading induced proximity entered industrial validation through deals by Merck, Chugai and others. WuXi AppTec surveys the trend and highlights its integrated CRDMO platform spanning PROTAC, molecular glues, RIPTAC and more.
International pharmaceutical media Life Sciences Review APAC exclusively named AsymBio the 'Integrated Biologics CDMO Company of the Year in APAC 2026' and included it in the 'Top CDMO in APAC' list, recognizing its one-stop biologics CDMO capabilities across antibodies and ADCs.
Asahi Kasei Therapeutics' oral antiviral Hovilpri (pritelivir) won FDA approval for acyclovir-resistant HSV mucosal-skin infections in immunocompromised adults — the first new-mechanism HSV therapy approved by the FDA in nearly three decades. The pivotal Phase 3 PRIOH-1 met its primary endpoint (63% vs 34% complete healing at day 28).
Roche's Tecentriq (atezolizumab) won FDA approval as adjuvant therapy for stage III dMMR colon cancer, cutting recurrence or death risk by 50%; Endeavor's Hedgehog-pathway inhibitor taladegib (ENV-101) met primary and key secondary endpoints in a Phase 2b IPF trial; Lilly's Taltz+Zepbound Phase 3b revealed immuno-metabolic links in psoriasis and obesity.
At CPHI Milan 2026 (62,000+ professionals, 2,900 exhibitors), WuXi Biologics showcased its integrated CRDMO platform, Global Dual Sourcing strategy and its two European hubs — Dundalk, Ireland (54,000 L) and Wuppertal, Germany — as pillars of supply resilience.
The 2026 Nobel Prize in Chemistry goes to Henri B. Kagan and Kenso Soai for discovering non-linear effects and autocatalysis in asymmetric organic synthesis—the chemical foundation for making single-enantiomer drug molecules, directly relevant to CDMOs and the pharmaceutical industry.
The 2026 Nobel Prize in Physiology or Medicine goes to Karl Deisseroth, Peter Hegemann and Georg Nagel for the discovery of optogenetics—using a light-sensitive algal protein to switch individual nerve cells on or off in a living brain.
The 2026 Nobel Prize in Physics goes to Francis Halzen for his decisive contributions to the IceCube Neutrino Observatory and the discovery of high-energy neutrinos of astrophysical origin.
A new KRW 93.48 billion European contract pushed Samsung Biologics' cumulative order total (on an MTOP basis) past $22 billion (~KRW 29.9 trillion). Its 845,000 L total capacity leads Switzerland's Lonza (~741,000 L) and China's WuXi Biologics (~305,000 L).
On 2 October 2026, Lonza and Asimov announced a strategic collaboration combining Asimov's LV Edge cell-line technology with Lonza's process development, scale-up and GMP manufacturing expertise to advance scalable, reproducible lentiviral vector (LVV) manufacturing for emerging in vivo applications.
BioDlink (TOT Biopharm, 1875.HK) reports rapid CDMO growth: 14 new CMC projects signed, bringing its total CMC pipeline to 134, with an order backlog of RMB 391 million, up 95.5% year over year. Its in-house bevacizumab (Pusintin) gained two more overseas approvals, reaching seven countries.
On 1 October 2026, Lonza announced it is advancing a preclinical aseptic spray drying program to give biopharma companies new formulation and delivery options for biologics constrained by high-dose subcutaneous administration, PK, stability or manufacturability. Based in Bend (US), the platform has passed proof-of-concept for mAbs, ADCs and peptides.
Samsung Biologics will participate in four major biotech events in October — BioJapan (Yokohama), CPHI Worldwide (Milan), World ADC (San Diego) and BIX Korea (Seoul) — showcasing its end-to-end CDMO capabilities, 845,000 L of capacity and growing ADC/bioconjugation expertise. Its cumulative 2026 orders now approach ₩30 trillion.
Powered by its generative-AI platform, Insilico Medicine nominated ISM1354—a novel small-molecule PCC targeting GIPR—for obesity, type 2 diabetes and cardiovascular indications; preclinical data show 75%–104% oral bioavailability, at least 18-fold greater plasma exposure than a clinical-stage benchmark, and a markedly wider safety window.
WuXi Biologics' drug substance and drug product facilities at the Wuxi Mashan site passed an unannounced two-week FDA GMP inspection, covering multiple FDA-approved monoclonal, bispecific, fusion-protein and enzyme products. The result reinforces the site's 13-year 100% audit-pass record and strengthens reliable commercial supply to U.S. partners.
On September 23, 2026, the FDA approved Elevar Therapeutics' highly selective, irreversible FGFR2 inhibitor Lyrfigtu (lirafugratinib) for adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma harboring FGFR2 fusions or rearrangements. Phase 1/2 ReFocus data showed 46% ORR, median DOR of 11.8 months, and median PFS of 11.3 months. WuXi AppTec's Research Chemistry Services (RCS) covalent-chemistry and fluorine-chemistry platforms are positioned to provide integrated chemical support for such precision-drug programs.
A lipid-siRNA conjugate for extrahepatic delivery advanced from post-PCC API process development to IND filing in just nine months on WuXi TIDES; after a change in molecular ownership, the client kept the program on WuXi AppTec's platform—a 100% retention rate.
WuXi XDC (2268.HK) held the GMP release ceremony for its Singapore manufacturing site at Tuas Biomedical Park, reaching the milestone in just two and a half years with both the BCM3 dual-function line and DP4 drug-product facility released — marking the transition of its “Global Dual-Sourcing” strategy from blueprint to reality.
The 2026 Global XDC Innovation Conference concluded in Wuxi on September 19, gathering over 1,500 global XDC leaders across a plenary and four core parallel forums to explore frontiers from ADCs and dual-payload ADCs to AOC/APC bioconjugates. As the core convening force, WuXi XDC continues to lead XDC technology innovation and its global capacity build-out.
WuXi AppTec's integrated TIDES CRDMO platform helped a client advance a divalent dual-targeting siRNA–GalNAc conjugate from PCC to IND submission within 8 months, improving crude purity from 40% to 75%, nearly doubling yield, and enabling parallel drug substance and drug product development.
The 2026 Global XDC Innovation Conference opened in Wuxi on September 18, co-hosted by WuXi XDC and BioValley. Day 1 drew over 1,400 attendees across the Biopartnering Forum, plenary session, two parallel forums, panel discussions and exhibitions.
WuXi XDC (2268.HK) announced an out-licensing collaboration with Ona Therapeutics on its proprietary WuXiTecan-2 payload-linker technology: an exclusive global license for developing an ADC candidate against a single target, with deal value comprising an upfront payment, development/regulatory/sales milestones, plus tiered royalties on net sales upon commercialization. Building on their 2024 collaboration, this is the second partnership between the two companies — and WuXiTecan-2's second out-licensing deal within six months.
Acepodia announced that IND applications for its dual-payload ADC candidate ACE723 have been approved by both the US FDA and China's NMPA, making it the first candidate from Acepodia's AD2C platform to enter clinical development. As CDMO partner, Porton delivered end-to-end development and GMP IND clinical supply for the dual-payload ADC, spanning payload-linker, antibody and ADC development and manufacturing.
The Chongqing Liangjiang Drug Product Manufacturing Site has again passed its ISO 14001 and ISO 45001 recertification audits, maintaining the dual-system certification first obtained in 2023. The 34,000 m² site is Porton Pharma Solutions' integrated drug-product CDMO platform.
The project covers 253.7 mu with total investment of RMB 3 billion and will add 200 tonnes per year of high-end pharmaceutical intermediates and APIs, with Phase 1 slated to start production in June 2028. It is Pharmaron's second major capacity investment this year, following an ~RMB 2 billion R&D and manufacturing site signed with Hangzhou's Qiantang District in May.
The initiative encodes short-lived genetic instructions in circular mRNA (cmRNA) packaged in targeted lipid nanoparticles, arming a patient's own T cells to recognize and clear senescent cells, activated fibroblasts and autoreactive lymphocytes — addressing initiating cell populations rather than downstream pathology, via a single, self-limiting dose.
At the Morgan Stanley Global Healthcare Conference on 15 September 2026, Lonza outlined its transition to a pure-play CDMO: a 60% Capsules & Health Ingredients divestment by year-end, 28% Advanced Synthesis growth in H1, and CapEx normalizing from over 20% to 14%–19% of sales.
The new facility will feature two PSD-4 spray-drying units and is expected to establish Lonza as the leading CDMO provider of commercial-scale spray-drying PSD-4 capacity in the US. Completion is expected in 2029, initially creating more than 80 jobs. The Bend site has nearly 50 years of pharmaceutical manufacturing history and has contributed to more than 2,000 potential medicines.
GENESIS-IPF-3, the Phase III trial of Rentosertib (ISM001-055) in idiopathic pulmonary fibrosis (IPF), has dosed its first patient at Peking Union Medical College Hospital, with Shanghai Pulmonary Hospital enrolling its first patient the same day. The 52-week study plans to enroll 320 patients across 47 centers in China — the first drug with both an AI-identified target and an AI-designed molecule to reach Phase III.
The US$262.182 million (about KRW 350.8 billion) contract will be manufactured at Samsung Biologics' Songdo site and runs through December 31, 2033. It is the sixth contract disclosed this year and lifts cumulative order intake to US$21.9 billion. The client and product were not disclosed under confidentiality terms.
At its September 3 investor briefing Asymchem disclosed a backlog of US$1.673 billion, up 53.77% year on year, and maintained full-year revenue growth guidance of 19%–22%. It is currently serving one commercial peptide project, with PPQ and commercial stocking expected to begin in 2027 and peptide capacity reaching full utilization only by 2028.
The US-dollar-settled zero-coupon convertible bonds, with a principal of RMB 2.18 billion maturing in 2027, settled on September 2 at an initial conversion price of HK$36.08 per H share, raising about US$327.2 million net — roughly 70% of which will fund expansion of laboratory services and CDMO services.
The offer of CHF 44.31 net in cash per share implies an aggregate equity value of approximately CHF 1.46 billion and a 40% premium to PolyPeptide's unaffected share price on April 10, 2026. PolyPeptide's board unanimously recommends acceptance, and largest shareholder Draupnir (~55.65%) has undertaken to tender all its shares. The offer period runs from September 15 to October 12, 2026.
WuXi Biologics published a thought-leadership piece framing itself as the full-lifecycle 'expert' for complex molecules such as bispecifics and ADCs: H1 2026 added 169 integrated projects (71% bispecific/ADC), with complex molecules over 50% of H1 revenue (up ~30% YoY); technology matrix spanning WuXiBody™, WuXiDARx™, WuXia™ TrueSite and WuXiUP™ converts complex risk into industrialization certainty.
WuXi XDC announced GMP release of its first Singapore drug-product facility DP4 for bioconjugates, with annual capacity up to 8 million vials of liquid or lyophilized dosage form. From groundbreaking to GMP release in just 29 months, DP4 is the second capacity facility in Singapore after BCM3.
Porton (300363.SZ) announced that Dr. Yongli Zhong, former Principal Scientist at Merck & Co., has joined as Chief Scientific Officer (CSO) to lead innovative process-technology solutions for customers. At Merck for 21 years, Dr. Zhong led process development for multiple innovative drugs from PCC to commercial, with 20+ patents and 90+ papers.
Excluding a RMB 330M impairment from terminating the Slovenia project, continuing-operations net profit reached RMB 92.3M, up ~329% YoY. Gross margin improved by nearly 5 ppts; CGT and New Molecules order intake grew 75% and 84% respectively.
WuXi AppTec's Research Chemistry Services (RCS) shortened a client's steroid synthesis from 7 steps to 3 while doubling yield; two years later, when kg-scale failed, RCS validated across four scales and introduced continuous precipitation, cutting 100g production from two weeks to four days — winning deep collaboration.
H1 2026 CDMO revenue reached RMB 199M (+157.0% YoY), about 80% of total revenue, with 116 cumulative customers (16 overseas); the project funnel expanded to 236 (176 early-stage/preclinical, 134 CMC, ~60% ADC/XDC); the first commercial-CDMO order was secured for Lepu Biopharma's ADC Meiyouheng®; backlog reached RMB 391M (+95.5% YoY); 26 GMP inspections and audits in H1 all passed. WuXi XDC completed its tender on 2026-03-31 and held ~60.67% at end-June; the two sides signed a three-year continuing connected transaction agreement in late May covering a staged CDMO order book worth nearly RMB 770M.
CDMO services new orders jumped over 50% with segment revenue of RMB 1.88B (+32.78%); the company guides 15–20% full-year revenue growth. Revenue from the global top-20 pharma clients surged 31.95%.
Small-molecule players extend into linker-payloads, biologics players extend from mAbs into conjugation, and large CDMOs fill gaps in drug product and fill-finish — different starting points, the same destination: integrated XDC. China's H1 2026 license-out value neared USD 100B.
A Phase 2 triple stapled peptide project that stalled at another CDMO was transferred to WuXi AppTec. Through integrated WuXi TIDES execution — in-house UAA supply in 6 weeks, re-engineered RCM lifting crude purity 33%, and a metal-scavenging step cutting residual ruthenium ~75-fold — kilogram-scale GMP API was delivered in 8 months and Phase 2 CTM released in 11.
BCM3 offers 200–2,000 L antibody-intermediate batches and up to 2,000 L conjugated drug substance batches. From announcement to GMP release took only two and a half years, marking a new stage in the company's "China + Singapore" dual-site global capacity layout.
H1 gross profit rose 26% to RMB 1.38B and net profit grew 23.7% to RMB 617M, completing a Q2 inflection after a weak Q1. Chemical macromolecule CDMO backlog keeps doubling; 52 clinical peptide programs include 19 obesity-related projects.
In 2026, with domestic biotech funding cold and legacy Western CDMOs retreating, top players are moving in opposite directions — WuXi turning "M&A + guaranteed orders" into a capacity harvester, while Lonza and Catalent use "divestment + refocusing" as a margin-repair playbook.
The 10,000+ sqm site offers process development, drug substance and drug product capabilities, with the deal expected to close in Q3 2026 — the latest move in WuXi's counter-cyclical capacity buying at domestic asset-price lows.
Suzhou Porton Bio received the license from the Jiangsu MPDA, qualifying it for commercial CGT contract manufacturing. H1 CGT new orders grew ~75% YoY; lentiviral platform material localization exceeds 96%.
Adjusted non-IFRS net profit of RMB 11.57B, up 83.2% YoY; backlog of RMB 66.4B, up 25.2%; full-year revenue guidance raised to RMB 58.5–60.5B. Attributable net profit topped RMB 10B in H1 for the first time.
Plants 1–4 ran at full utilization with operating profit of KRW 586.4B and an operating margin of 44.4%; Plant 5 PPQ batches are ramping, and the company expects to hit the upper end of its 15–20% full-year revenue growth guidance.
H1 sales of CHF 3.4B with a CORE EBITDA margin of 34.8%; Advanced Synthesis posted CER sales growth of +27.7% with a 48.1% margin. The Visp large-scale mammalian facility began commercial operations, and a new ADC fill-finish line is being added in Stein.
From 982 integrated projects at end-April 2026 to 1,000 by July, the project pool keeps expanding — complex molecules now exceed 50% of the portfolio, with bispecific/multispecific antibodies as a key growth engine.
The all-cash public tender offer for the Swiss peptide CDMO is expected to close by end-2026, adding six cGMP plants across Belgium, France, India, Sweden and the US — a major step in Samsung's multi-modality strategy.
The new capacity, inside an existing GMP facility, is expected to be operational in 2028 and will support both clinical and commercial programs, complementing Lonza's antibody, conjugation and fill-finish ecosystem in Visp and Stein.
The deal adds 60,000 L of drug substance capacity (2×20,000 L + 2×10,000 L bioreactors) and establishes the company's first US manufacturing presence. Once Songdo Bio Campus II is complete, total capacity will reach 1.385M L.
643 cumulative clients, 252 integrated CMC programs (226 integrated ADC projects), 18+ PPQ projects; the planned Jiangyin payload-linker facility will have capacity equal to five times the current Wuxi base.
Lonza agreed to divest its Capsules & Health Ingredients business to private-equity firm Lone Star Funds for an enterprise value of CHF 2.3 billion, retaining a 40% stake and receiving CHF 1.7 billion upfront. The deal, expected to close in H2 2026, completes Lonza's transformation into a pure-play pharmaceutical CDMO.