WuXi AppTec Co., Ltd.

Fresenius is aiming to double its biopharma revenue by 2030 compared to 2025 levels, with a pipeline expansion key in achieving that. Credit: Kittyfly/Shutterstock.com. Fresenius and WuXi Biologics will work together to develop up to 37 biosimilar candidates targeting a range of therapeutic areas, giving the German company ample scope to bolster its pipeline. The exclusive development agreement will give Fresenius access to potential first-to-market candidates over the next decade that address more than €370bn ($415bn) in originator sales, the deal claims. Financial terms of the deal, which the companies say is the largest ever biosimilar-related development in history, were not disclosed. According to Fresenius, working with contract research, development, and manufacturing organisation (CRDMO) WuXi could increase its portfolio from today’s total of 29 marketed and pipeline molecules to as many as 66 in the future. The next-generation portfolio is expected to span 13 therapeutic areas, including expanding into neurology, nephrology and cardiopulmonary. In terms of modalities, the deal includes monoclonal and bispecific antibodies, antibody-drug conjugates and fusion proteins. Fresenius will consider market attractiveness, development risk, and expected returns when deciding which assets will be selected. The company will hold exclusive global commercialisation rights, including marketing authorisations, and the full economics of each commercialised product under the agreement. Michael Sen, Fresenius CEO, said: “We are doubling down on our biopharma business. With this agreement, we are gaining access to development capabilities in a market where speed and scale are of the essence. It provides a disciplined, scalable way to potentially triple our portfolio while retaining economic ownership, strategic control and the flexibility to allocate capital to the most compelling opportunities.” The agreement follows Fresenius’ takeover worth up to €750m of biopharmaceutical company mAbxience in October 2026. Via the deal, Fresenius gained three good manufacturing practices (GMP)-approved manufacturing facilities across Europe and South America. Though the long-term manufacturing strategy will be determined on a candidate-by-candidate basis, the mAbxience network is likely to be leveraged. For Fresenius, the agreement aligns with a targeted R&D uptick. The company is aiming to double its biopharma revenue by 2030 compared to 2025 levels, with a pipeline expansion key in achieving that. The pharma industry is currently experiencing one of its largest ever patent cliffs. Some of the top-selling prescription drugs in the world will soon be competing with generics or biosimilars. Sandoz is also targeting a pipeline expansion, recently announcing an ambitious growth strategy that could see the manufacturer harbour more than 100 biosimilars in its portfolio by 2040. China ties deepen In a wider industry context, the deal marks the latest in a long line of partnerships between Western companies and Chinese drug developers. Licensing deals between US and Chinese biopharma companies hit record highs in 2024, a 280% increase from 2020, according to analysis by GlobalData , parent company of Pharmaceutical Technology . Further GlobalData analysis has found that the top 20 deals in China since 2024 were worth a total of $85.6bn, with more than 20% of those deals occurring in H1 2026. However, most high-profile deals revolve around innovator drugs. Some international relationships are hitting choppy waters. American partnerships and investments into Chinese pharma companies have come under scrutiny from the US Government amid a national security policy drive. WuXi Biologics is separate from WuXi AppTec, with the latter, which is one of the largest CRDMO’s in the world, having been designated as a Chinese military company by the US Department of Defense earlier this year. A federal judge has since issued a preliminary injunction blocking the Pentagon from enforcing the designation.

【Suzhou, China, 02 November 2026】– CANbridge Pharmaceuticals Inc. (“CANbridge” or the “Company”, Stock Code: 1228.HK), a global biopharmaceutical company focused on rare diseases, is committed to the research, development and commercialization of innovative therapies. The Company announced key pre‑clinical progress for CAN204, its next‑generation dual‑AAV gene‑therapy candidate for Duchenne muscular dystrophy (DMD). Findings from the CAN204 program have been accepted for an oral abstract presentation titled An RNA-based dual AAV vector system to deliver large dystrophins with high efficiency to muscle for the treatment at the American Society of Gene and Cell Therapy’s Breakthroughs in Cell and Gene Therapy Conference (“ASGCT Breakthroughs 2026”), to be presented in Nashville, Tennessee, on November 12, 2026. Hosted by the American Society of Gene and Cell Therapy (ASGCT), ASGCT Breakthroughs is a high‑profile thematic conference in cell and gene therapy, serving as an important barometer for the translation of cutting‑edge technologies. The meeting prioritizes high‑impact research with clear translational potential. Oral presentation slots are highly competitive and granted only to a limited number of studies featuring notable innovation and translational value. Acceptance of this oral presentation reflects strong validation from the international scientific review committee specifically for CANbridge’s DMD program and more broadly demonstrates the Company’s global R&D competitiveness in advanced gene therapies. CAN204 is CANbridge’s next‑generation dual‑AAV gene‑therapy candidate for DMD, built upon the StitchR™ (Stitch RNA) technology platform that was licensed to CANbridge for global and exclusive use for Dystrophinopathies from Scriptr Global. DMD arises from loss‑of‑function mutations in the DMD gene encoding dystrophin, a large cytoskeletal protein of 427 kDa. Constrained by AAV packaging capacity, current AAV‑based gene‑therapy candidates can only deliver sequences encoding truncated micro‑dystrophin, which typically covers only 30‑40% of the full‑length coding sequence and may lack important functional subdomains, potentially limiting clinical efficacy. Leveraging self‑cleaving ribozymes, the StitchR™ platform enables precise trans‑ligation of two precursor RNAs delivered by separate AAV vectors to generate a single large mRNA. This overcomes AAV packaging limits and enables efficient expression of midi‑dystrophin transgenes up to 7.5 kb, representing a potentially transformative therapeutic approach for DMD. Underpinning work for the StitchR™ technology has been published in Science. CANbridge continues to advance the screening and evaluation of multiple AAV capsids for robust delivery of StitchR™ to the muscle and heart and optimize the therapeutic payload. In the pre‑clinical studies to be presented at ASGCT Breakthroughs 2026, MYO4A-delivered CAN204 exhibited optimal muscle protection in the mdx DMD mouse model at therapeutically relevant doses between 5e13 vg/kg to 2e14 vg/kg; muscle force recovered to levels comparable to healthy wild‑type controls following repeated eccentric contraction, and was significantly superior to AAVMYO2 (p<0.0001), AAVMYO3 (p<0.001), AAV9 (p<0.0001) and vehicle control (p<0.0001). Studies also demonstrated that MYO4A, AAVMYO2 and AAVMYO3 all showed greater muscle tropism than conventional AAV9. Even at a lower dose, MYO4A-StitchR-midi-Dys achieved robust muscle protection. These accumulating pre‑clinical data lay a solid foundation for identifying clinical-candidate AAV capsids that perform similar or superior to MYO4A and further advance CAN204 towards human clinical validation. About Duchenne Muscular Dystrophy (DMD) Duchenne muscular dystrophy (DMD) is one of the most common forms of progressive muscular dystrophy and is listed as entry No. 98 on China’s First Catalogue of Rare Diseases (2018). It is an X‑linked recessive inherited rare neuromuscular disorder predominantly affecting boys. Onset occurs in early childhood, characterized by rapidly progressive muscle degeneration and weakness. Patients typically lose ambulation around age 12 and often succumb to cardiac and respiratory muscle weakness in their twenties. Approximately 250,000 patients worldwide live with DMD, representing substantial unmet medical need. About CANbridge CANbridge Pharmaceuticals Inc. (Stock Code: 1228.HK) was founded in 2012 and listed on the Main Board of HKEX in 2021. The Company is a global biopharmaceutical company, with a foundation in China, committed to the research, development and commercialization of transformative therapies to treat rare diseases. As of June 30, 2026, the Company has a comprehensive pipeline of 8 drug assets targeting prevalent rare diseases that have high unmet needs and significant market potential. The robust pipeline includes 3 marketed products (Hunterase®, Livmarli®, Gaurunning®) and 1 drug candidate at the late clinical stage, covering biologics, small molecules and gene therapies. In the rare disease area, the Company currently has seven biologic and small molecule product candidates. These include MPS II (Hunter syndrome) and other lysosomal storage disorders (LSDs), complement-mediated disorders, hemophilia A, metabolic disorders and rare cholestatic liver diseases including Alagille syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC). Furthermore, CANbridge is investing in the R&D of next-generation gene therapy technologies, which will provide novel, potentially curative therapies for rare genetic diseases with limited treatment options. To support the research, development and commercialization of its pipeline, the Company has built a global partner network including, but not limited to, WuXi AppTec, WuXi Biologics, Baheal Medical, GC Pharma, Mirum, Privus and Scriptr Global. ONLY FOR SCIENTIFIC COMMUNICATION AND USE BY MEDICAL AND HEALTH PROFESSIONALS

Next-generation antibody-drug conjugates, bispecifics, radiopharmaceuticals, tyrosine kinase inhibitors ... Fierce provides a deep dive into the hunt for the next Enhertu in breast cancer. ESMO 2026 data featured Chinese assets backed by Big Pharma. Gilead and Astellas struck $1 billion-plus deals for immunology and immuno-oncology assets. And more. 1. As ADC king Enhertu rewrites HER2 breast cancer care, the hunt for what comes next is barely out the gate BioNTech sees ‘limited’ benefit to ADC after phase 3 reveals modest efficacy, ILD cases As Daiichi Sankyo and AstraZeneca’s Enhertu marches into earlier lines of HER2 breast cancer treatment and becomes the world's best-selling ADC, drugmakers are facing an uphill battle trying to develop new breast cancer options upon Enhertu progression or to replace it. Case in point, BioNTech’s DualityBio-partnered t-pam showed “modest” progression-free survival benefit and a higher-than-expected interstitial lung disease rate in a phase 3 trial in HR-positive, HER2-low breast cancer. Fierce took a deep dive into the current HER2 breast cancer drug development landscape. 2. ESMO: Merck, Kelun’s ‘workhorse’ ADC posts major tumor progression benefit in PD-L1-negative NSCLC ESMO: In sac-TMT’s first global phase 3 win, Merck sees ‘pretty consistent’ data with China Merck outlines 2027 as ‘another year of investment’ despite recent clinical wins Merck & Co.’s sac-TMT, used alongside Keytruda, reduced the risk of progression or death by 51% versus Keytruda-chemo in first-line, PD-L1-negative non-small cell lung cancer in a China phase 3 conducted by Kelun-Biotech. Meanwhile, in sac-TMT’s first global phase 3 readout, Merck saw “very consistent” endometrial cancer data with previous Chinese results. The New Jersey pharma now plans to move its PD-1xVEGF candidate into phase 3 development, including combinations with sac-TMT, in first-line NSCLC. 3. ESMO: Bristol Myers CMO touts ‘5 out of 5’ positive phase 3 trials for bispecific ADC iza-bren Bristol Myers Squibb’s EGFRxHER3 ADC iza-bren, showed 60% and 59% PFS benefits in two China phase 3 trials in previously treated EGFR-mutant NSCLC and HR-positive, HER2-negative breast cancer, respectively. BMS’ chief medical officer, Cristian Massacesi, M.D., called the drug’s clean sweep of five positive phase 3s “quite remarkable.” 4. ESMO: Takeda’s $1.2B bet on Innovent ‘absolutely’ pays off with details of ADC’s phase 3 win Takeda’s CLDN18.2 ADC, licensed from Innovent Biologics, improved median overall survival to 10.2 months, versus 6.9 months for investigator-selected regimens, in a phase 3 trial for third-line CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma. While approval bids are underway in Japan and China, Takeda plans to start global phase 3 trials for the drug in gastric and pancreatic cancers. 5. Gilead to pay $1.3B upfront for PepStar’s oral IL-23 challenger to J&J’s Icotyde Gilead will acquire PepStar Therapeutics’ oral IL-23 receptor inhibitor program for $1.275 billion. The drug would be a rival to Johnson & Johnson’s Icotyde, which the FDA approved for plaque psoriasis in March. BMO Capital Markets analysts noted that less frequent dosing and the potential to combine with Gilead’s emvistegrast could represent key points of differentiation for the candidate. 6. Astellas makes $1.3B bet on Audax’s preclinical push to reverse decades of IL-12 woes Astellas is offering up to $285 million in upfront and option fees to potentially license a preclinical IL-12 program from Audax Biosciences. Up to $1.05 billion in milestones is up for grabs if the cytokine-antibody fusion molecule can address the dosing and toxicity issues that have thwarted IL-12 as an immuno-oncology drug class. 7. ESMO: AZ, Hutchmed’s Orpathys combo shows post-Tagrisso power in MET-driven lung cancer 8. ‘Infinite potential’: Akeso CEO looks for more ivonescimab combos amid AstraZeneca investment, new phase 3 win 9. ESMO: BMS’ Massacesi hails ‘very promising’ data for BioNTech-partnered PD-L1xVEGF-A drug 10. GSK’s B7-H3 ADC drives 67% cancer risk reduction in Hansoh's phase 3 China trial 11. ESMO: GSK cancer R&D chief says mo-rez data ‘reinforces our belief’ in ADC as phase 3 push ramps up 12. WuXi AppTec bucks DOD uncertainty through Q3, lifting forecast for 2026 13. Ascletis’ challenger to Lilly’s Foundayo hits goals in phase 2 diabetes trial 14. Sun locks in first DTC spot for alopecia areata med Leqselvi