Revefenacin

BFC Capital Market Update (September 26-October 9） Market Overview Hong Kong Gains as Mainland Stocks Retreat; Healthcare Indices Decline Across Regions Global equity markets were mixed last week. In Hong Kong, the Hang Seng Index rose 1.0%, reducing its 2026 decline to 5.5%. Mainland equities moved lower, with the Shanghai Composite down 0.7% and the CSI 300 down 0.9%. On October 9, the Communist Party of China Central Committee and the State Council issued guidance on developing new quality productive forces, setting out 19 priority measures covering technological and industrial innovation, development model innovation, and institutional reform. In the U.S., the Nasdaq Composite rose 0.2% and the Dow gained 0.83%, while the S&P 500 fell 0.59%. Year-to-date, the Nasdaq is up 17.2%. Healthcare indices declined across all three markets. In Hong Kong, the Hang Seng Healthcare Index (HSHCI) fell 2.7% last week but remains up 2.5% year-to-date, outperforming the Hang Seng Index by 8.0 percentage points in 2026. On October 7, the Hong Kong SAR Government provided a written update to the Legislative Council on public healthcare charging reform. The update reported fewer non-urgent accident and emergency cases and more beneficiaries of medical fee waivers, while emphasizing that the reform redirects public resources toward acute and severe cases, low-income patients, and treatments with high clinical value. Mainland healthcare also declined, with the SSE Pharmaceutical Index down 2.6%, the CITIC Pharma Index down 1.6%, the innovative drug index down 3.1%, and the medical device index down 1.5%. On October 8, the State Council approved the National Disability Prevention Action Plan for 2026 to 2030. The plan covers birth defects and developmental disorders, chronic disease complications, injury prevention, and rehabilitation services, with implications for early screening and diagnosis, neurological diseases, orthopedics, rehabilitation equipment, assistive devices, and long-term care. In the U.S., the Nasdaq Biotechnology Index (NBI) fell 0.3% last week but remains up 21.5% year-to-date, outperforming the Nasdaq by 4.2 percentage points. Major Biopharma Updates EMA Accepts Hengrui Pharma's Fuzuloparib Marketing Application in Prostate Cancer On October 9, Hengrui Pharma announced that the European Medicines Agency had accepted the marketing authorization application for fuzuloparib, a PARP inhibitor. The application is supported by the global Phase 3 FUZUPRO study of fuzuloparib plus abiraterone in metastatic castration-resistant prostate cancer. Median radiographic progression-free survival was 24.8 months in the fuzuloparib combination group compared with 19.9 months in the control group, with a hazard ratio of 0.71. Viatris to Acquire Pacira BioSciences for Approximately USD 1.65 Billion On October 8, Viatris announced an agreement to acquire Pacira BioSciences for USD 36.50 per share in cash, implying an equity value of approximately USD 1.65 billion. Pacira's marketed, patent-protected non-opioid products include EXPAREL for postsurgical pain and ZILRETTA for knee osteoarthritis pain. AbbVie and Genmab's Epcoritamab Cuts Progression or Death Risk by 51% in Frontline DLBCL On October 5, AbbVie and Genmab reported topline results from the Phase 3 EPCORE DLBCL-2 study. Subcutaneous epcoritamab, a CD3 x CD20 bispecific antibody, combined with R-CHOP reduced the risk of disease progression or death by 51% versus R-CHOP alone in previously untreated patients with high-risk diffuse large B-cell lymphoma. The hazard ratio was 0.49 and the p-value was less than 0.0001. The result supports moving a bispecific antibody from relapsed or refractory blood cancers into first-line treatment. Business development updates Between September 28 and October 8, 2026, global biopharma BD activity remained strong, with 15 reported licensing, collaboration, and M&A announcements. Chinese biotech innovation continued to attract multinational interest, highlighted by Hengrui’s oral GLP-1/GIP agonist licensing deal with Novo Nordisk, SciBrunch’s KRAS G12D inhibitor agreement with Merck, and Abogen’s RNA therapeutics partnership with Novartis. Major global collaborations included Sanofi and Regeneron’s expanded immunology alliance, involving $1 billion upfront and up to $7 billion in milestones, alongside growing investment in emerging modalities such as molecular glue degraders, RNA therapeutics, and next-generation antibodies. M&A activity was also significant, including Shionogi’s $2.0 billion acquisition of IntraBio, Viatris’s $1.65 billion acquisition of Pacira, and GE HealthCare’s $945 million acquisition of SOFIE. Overall, these transactions highlight three major industry trends: sustained demand for Chinese biotech assets, increasing investment in innovative therapeutic platforms, and strategic acquisitions to strengthen commercial portfolios and specialized capabilities. Biohaven licenses three IgG degrader programs to Ono for Japan and Asian markets Oct. 8, 2026, Biohaven Ltd. together with its wholly owned subsidiaries, ("Biohaven") (NYSE: BHVN) today announced that it has entered into a strategic licensing and collaboration agreement with Ono Pharmaceutical Co., Ltd. ("Ono") (TYO: 4528), under which Ono will obtain an exclusive license to develop and commercialize Biohaven's MoDE™ pan IgG degrader portfolio, led by BHV-1300 and including next-generation follow-on degraders BHV-1310 and BHV-1320, in Japan, South Korea, Taiwan, and the countries of the Association of Southeast Asian Nations (ASEAN). Alector Enters Global License Agreement with Genentech for Brain Penetrant GCase Enzyme Replacement Therapy for Parkinson’s Disease and Other Neurodegenerative Diseases October 5, 2026. Alector, Inc. (Nasdaq: ALEC), a biotechnology company focused on developing therapies to counteract the devastating progression of neurodegeneration, today announced it has entered into an exclusive global licensing agreement with Genentech, a member of the Roche Group, granting Genentech worldwide rights to develop and commercialize Alector’s AL050 program, its brain-penetrant engineered glucocerebrosidase (GCase) ERT. CSL and Alentis announce global partnership to develop and commercialise lixudebart for rare kidney and liver diseases October 5, 2026. CSL and Alentis Therapeutics today announced they have entered into an exclusive global collaboration agreement to co-develop and co-promote lixudebart, which has the potential to become a first-in-class therapy targeting claudin-1 across a range of kidney, liver and other diseases. Gate Bioscience and Lilly expand their protein-targeting discovery collaboration October 5, 2026. Gate Bioscience, a biotechnology company developing molecular gates, a new class of small molecule medicines that eliminate disease-causing proteins at their source, today announced an expansion of its collaboration and license agreement with Eli Lilly and Company (Lilly) to discover, develop, and commercialize molecular gate therapeutics. Abogen and Novartis agree on mRNA-encoded T-cell engagers and RNA program options October 2, 2026. Abogen Biosciences ("Abogen" or the "Group"), a clinical-stage biotechnology group pioneering RNA innovation, announced that it has entered into a licensing and option agreement with Novartis to advance RNA-encoded therapeutics. Hengrui licenses once-weekly oral GLP-1/GIP dual receptor agonist HRS-1596 to Novo Nordisk September 29, 2026. Novo Nordisk today announced that it has entered into a license agreement with Hengrui Pharma (600276.SH; 01276.HK) for HRS-1596, a phase 1-ready glucagon-like peptide-1 receptor (GLP-1R) and gastric inhibitory polypeptide receptor (GIPR) dual agonist, with potential for once-weekly oral dosing. SciBrunch licenses oral KRAS G12D (ON) inhibitor SPR2015 to Merck September 28, 2026. Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and SciBrunch Therapeutics Co., Ltd. (“SciBrunch”), today announced that they have entered into an exclusive global license agreement for SPR2015, an investigational preclinical oral KRAS G12D (ON) inhibitor. Tanabe licenses anti-IL-33 antibody MT-2990 to Tolerance Bio September 28, 2026. Tolerance Bio announced an exclusive license from Tanabe Pharma for MT-2990, renamed TLB-33, a clinical-stage antibody that neutralizes IL-33. Tolerance receives worldwide development and manufacturing rights across all indications and exclusive commercialization rights outside Japan; Tanabe retains Japanese commercialization rights. The antibody has been evaluated in more than 150 subjects, and Tolerance plans to begin Phase 2 development in 2027 to assess its potential to preserve thymic function and improve immune resilience. Tanabe is eligible for approximately $560 million in development and sales milestones, together with equity consideration and tiered royalties on net sales. Viatris announces acquisition of Pacira to add commercial non-opioid pain products October 8, 2026. Viatris and Pacira BioSciences announced a definitive agreement under which Viatris will acquire all outstanding Pacira shares for $36.50 per share in cash, representing an aggregate equity value of $1.65 billion. The acquisition adds EXPAREL, a liposomal bupivacaine product for postsurgical pain, and ZILRETTA, an extended-release triamcinolone injection for osteoarthritis knee pain. Viatris intends to expand these non-opioid products into selected international markets and combine them with its existing pain-management capabilities. The transaction is expected to close by year-end 2026, subject to customary conditions, and Pacira will become a wholly owned Viatris subsidiary. Shionogi plans a $2B acquisition of IntraBio to expand rare neurological disease assets October 5, 2026. Shionogi announced an agreement to acquire all outstanding shares of IntraBio for $2.0 billion in upfront cash consideration. IntraBio will become a wholly owned subsidiary of Shionogi Inc., adding AQNEURSA (levacetylleucine) and expertise in rare neurological diseases. AQNEURSA is approved in the United States and European Union for neurological manifestations of Niemann-Pick disease type C, and received an additional U.S. approval in September 2026 for ataxia in patients with ataxia-telangiectasia. The acquisition extends Shionogi’s rare-disease portfolio following its addition of RADICAVA and is expected to close between November and December 2026, subject to customary conditions. GE HealthCare to acquire SOFIE to expand PET radiopharmaceutical production and distribution October 5, 2026. GE HealthCare announced a definitive agreement to acquire SOFIE Biosciences from Trilantic North America for $945 million in cash. SOFIE brings a U.S. network of 15 PET radiopharmaceutical manufacturing sites operating 21 cyclotrons, together with a CDMO site focused on theranostics. The acquisition expands GE HealthCare’s ability to manufacture and deliver short-lived PET tracers and adds SOFIE’s Phase 3 fluorine-18 FAPI-74 imaging program, for which GE HealthCare already holds rights outside the United States. SOFIE will join the Pharmaceutical Diagnostics segment when the transaction closes, expected in the first half of 2027, subject to regulatory approvals and other conditions. Fresenius takes full ownership of mAbxience after acquiring the remaining 45% October 1, 2026. Fresenius announced that it had acquired the remaining 45% of mAbxience from Insud Pharma and Invim Corporativo for consideration of up to €750 million, including a €50 million payment contingent on site approvals. The transaction was signed and completed on September 30, 2026. Fresenius had held a 55% majority stake since 2022; mAbxience is now wholly owned within Fresenius Kabi’s Biopharma business. Full ownership gives Fresenius greater control over biosimilar development, manufacturing capacity and commercialization, as well as the full economic benefit of the platform. Fresenius expects the acquisition to be immediately accretive to Group core earnings per share. Zymeworks updates financial guidance following the Theravance acquisition September 28, 2026. Zymeworks announced final transaction details and revised financial guidance following completion of its previously announced Theravance Biopharma acquisition. Theravance shareholders received $17.00 in cash per share. The acquisition adds YUPELRI (revefenacin), with a 35% share of net U.S. profits and royalties on sales outside the United States under the Viatris collaboration. Financing included a $350 million OMERS note, serviced through an assignment of 75% of YUPELRI profit-share cash flows. Zymeworks now expects 2026 revenue of $278–292 million and adjusted EBITDA of $114–128 million, while evaluating Theravance’s remaining R&D assets and partnership opportunities. Roche and Defand collaborate on molecular glue degraders October 8, 2026. Defand Therapeutics announced a research collaboration and license agreement with Roche to discover molecular glue degraders against multiple oncology and immunology targets. Defand will use its proprietary screening platform for early discovery, with programs transferred to Roche at agreed research stages for subsequent preclinical and clinical development. Roche will hold exclusive global commercialization rights and has an option to add further targets. The financial structure includes an upfront payment, potential milestone payments and tiered royalties on net sales, but payment amounts were not disclosed in the company announcement. The available announcement is a Chinese-language release republished by industry media. Regeneron and Sanofi expand their alliance with four next-generation antibodies October 1, 2026. Sanofi and Regeneron expanded their global antibody alliance to co-develop and commercialize four long-acting immunology programs targeting IL-13, IL-4, IL-4Rα and an IL-4/IL-13 bispecific. REGN20423, the IL-13 antibody, is in Phase 1 for atopic dermatitis; the other three programs are expected to enter clinical trials in 2027. Sanofi will pay Regeneron $1 billion upfront, with up to $7 billion in additional development, regulatory and commercial milestones. The partners will share development and commercialization costs equally and split future profits 50:50 globally. Regeneron will lead R&D and Sanofi commercialization; the existing Dupixent profit-sharing arrangement remains unchanged. Wave receives a $12M selection milestone under its existing GSK siRNA collaboration September 30, 2026. Wave Life Sciences announced that GSK had selected a candidate for a hepatology indication to transfer into GSK’s development portfolio under their existing research collaboration. The program uses Wave’s proprietary SpiNA-design GalNAc-siRNA technology, and candidate selection triggers a $12 million milestone payment to Wave. Wave is also eligible for up to $330–375 million in development, launch and commercial milestones for each collaboration program, plus tiered royalties on net sales. Three additional programs are advancing toward potential candidate selection. The announcement did not disclose the selected candidate’s target or drug code.

跨国药企的BD和并购动作依然密集。 从艾伯维以约109亿美元完成对Apogee Therapeutics的收购，到礼来完成对AtaiBeckley的收购，再到Telix斥资16.5亿美元推进对ITM的收购，以及诺华、GSK等围绕技术平台和核心管线展开资产交易。 近期多笔交易呈现出一个较为明显的特点：相比从早期研发阶段开始押注，成熟临床资产、商业化产品以及能够解决研发关键问题的平台技术，正在获得更多关注。 9月3日，艾伯维完成对Apogee Therapeutics的收购，交易股权价值约109亿美元。 Apogee的核心资产包括处于后期开发阶段的IL-13单抗zumilokibart，以及针对哮喘等疾病开发的项目。此前，zumilokibart已经在特应性皮炎临床研究中显示出积极结果，同时具备较长给药间隔的潜力。此次收购完成后，艾伯维进一步补充了自身在免疫领域的产品梯队。 9月11日，礼来完成对AtaiBeckley的收购。 AtaiBeckley是一家临床阶段生物科技公司，核心资产BPL-003用于治疗难治性抑郁症，已经进入后期临床开发阶段，并获得美国FDA突破性疗法认定。此次交易的初始股权价值约28亿美元，另有最高约10亿美元的或有价值权安排。 与单纯购买早期研发项目相比，礼来此次获得的是一个已经进入临床后期、同时拥有后续产品梯队的神经科学管线。 9月21日，Telix宣布以16.5亿美元的预付款基础价格收购德国同位素技术企业ITM Isotope Technologies Munich，交易总对价最高可达23.5亿美元。 这笔交易的价值并不只在于一款药物。 ITM拥有治疗性放射性同位素生产能力，包括镥-177、锕-225和铽-161等，同时拥有处于商业化前阶段的ITM-11。该候选药用于胃肠胰神经内分泌肿瘤治疗，已经完成Ⅲ期开发。 对于Telix而言，收购ITM实际上是在补齐放射性药物产业链，从研发和产品管线进一步延伸至关键原材料和生产能力。 同样值得关注的是诺华对技术平台的布局。 9月16日，Sironax宣布，诺华已行使独家选择权，获得其专有脑部递送平台的全球权利，交易金额为1.25亿美元。 这一平台的意义并不局限于某一个候选药物，而是试图解决大分子药物进入中枢神经系统的递送难题，可用于单抗、肽、蛋白质、基因疗法等多种治疗方式。交易完成后，Sironax仍将保留利用该平台开发部分资产的权利。 GSK的动作则聚焦于T细胞衔接器技术。 9月15日，GSK与中国生物科技公司恩沐生物达成最高7.5亿美元的交易，获得一款三特异性T细胞衔接器的全球权利，用于多发性骨髓瘤治疗，预计2027年进入Ⅰ期临床。 这已经不是GSK第一次从恩沐生物引进TCE资产。2024年，GSK曾以最高8.5亿美元的交易规模获得恩沐生物一款用于自身免疫疾病的TCE资产。 如果把这些交易放在一起看，可以发现，跨国药企近期的出手逻辑正在变得更加清晰。 一类是已经拥有临床验证的后期资产。艾伯维收购Apogee、礼来收购AtaiBeckley，都属于通过并购快速获得临床阶段管线。 另一类是已经具备商业价值的成熟产品和现金流资产。Zymeworks于9月23日完成对Theravance Biopharma的收购，获得YUPELRI等资产。Zymeworks随后披露，YUPELRI预计能够立即贡献收入和现金流。 还有一类则是平台型技术。诺华布局脑部递送平台、GSK连续押注TCE，本质上并非只买一款药，而是在为未来的产品开发能力提前布局。 值得注意的是，9月底阿斯利康对Summit Therapeutics进行20亿美元战略股权投资，也进一步体现出跨国药企正在通过更加灵活的方式获得创新资产和技术合作机会。双方将围绕ivonescimab及阿斯利康ADC药物开展联合临床开发。 从这些交易来看，当前跨国药企的外部创新策略并非单纯追求“越早越便宜”，而是在研发风险、资产价格和上市周期之间寻找新的平衡。 对于拥有成熟临床资产、差异化技术平台以及产业化能力的生物科技公司而言，这也意味着新的机会：真正能够证明临床价值、解决关键技术问题，或者已经具备商业化基础的资产，正在成为跨国药企BD和并购市场的重要筹码。 来源：思齐俱乐部 全新升级，思齐圈公开课 下半年，精彩预告！