对于双方的合作，市场似乎并不买单，10月9日，诺诚健华A股收于26.74元/股，下跌6.24%，10月10日 继续下跌9.16%。 究其原因，业界认为此次授权的适应症，并非奥布替尼核心适应症。作为一款口服小分子BTK抑制剂， 奥布替尼(商品名为宜诺凯)适应症目前聚集在血液肿瘤领域，并在2022年被纳入国家医保目录，覆盖复 发/难治性慢性淋巴细胞白血病/小淋巴细胞淋巴瘤(r/r CLL/SLL)及复发/难治性套细胞淋巴瘤(r/r MCL)， 2024年扩展至复发/难治性边缘区淋巴瘤(r/r MZL)，为中国首个获批该适应症的BTK抑制剂。今年4月， 该药还获批用于治疗一线难治性慢性淋巴细胞白血病/小淋巴细胞淋巴瘤。再者，与诸多创新药企"缺 钱"的情况不同，诺诚健华现金储备雄厚，截至今年上半年，公司货币资金为69.81亿元。 10月9日，诺诚健华发布公告，全资子公司InnoCare Pharma Inc.与纳斯达克上市公司Zenas BioPharma,Inc.(以下简称Zenas)签署授权许可协议，将具有自主知识产权的产品奥布替尼及2项临床前资 产有偿许可给Zenas，使其可以开发、生产、商业化或以其他方式利用 ...

10月8日，诺诚健华一则海外授权许可公告，在次日资本市场引发鲜明分化——公司A股股价开盘后快 速跳水，收跌6.24%，港股收跌11.64%；而交易对手方、纳斯达克上市的Zenas股价却强势上涨 24.22%。 诺诚健华把自家BTK抑制剂奥布替尼在多发性硬化症（MS）等自身免疫疾病领域的海外权益，以及两 款临床前资产有偿许可给Zenas，换来1亿美元首付款和近期里程碑付款，外加Zenas 700万普通股股 票，潜在交易总价值超过20亿美元。 根据交流会说明，首付款与股权价值叠加后合计2.8亿美元，行业对比来看首付比尚可。这已是奥布替 尼与全球生物技术巨头Biogen"分手"后的二次出海。诺诚健华此次虽也接洽过MNC（跨国制药公 司），但最终未再选择，而当前创新药全球化模式正悄然发生变化。 1亿美元首付+15%股权，曾接洽MNC却牵手Zenas 笔者梳理发现，市场针对诺诚健华此次合作偏谨慎的情绪主要集中在两个方面：一是认为首付金额未完 全匹配预期，二是合作方不够知名。 根据公告，诺诚健华此次出让的并非奥布替尼全部海外权益，而是涵盖多发性硬化领域的全球权益，包 括全球独家开发、生产和商业化权利，以及排除大中华区及东 ...

诺诚健华公告显示，公司在美国的全资附属公司InnoCare，与一家美国生物制药公司Zenas达成授权许 可协议，Zenas将获得诺诚健华核心产品——奥布替尼在多发性硬化领域的全球开发和商业化权益，以 及奥布替尼在非肿瘤的其他治疗领域的开发与商业化权益。 此外，《每日经济新闻》记者了解到，Zenas还获得两款临床前分子(尚未进入临床试验阶段的潜在药物 分子)，即一款新型口服IL-17AA/AF抑制剂和一款透脑性口服TYK2抑制剂的相关权益。 根据诺诚健华公告，为此，Zenas将向诺诚健华支付达1亿美元的首付款和近期里程碑付款，包括2026年 达成的里程碑付款，以及向诺诚健华发行达700万股Zenas普通股股票，包括在2026年初达到里程碑时向 诺诚健华发行的股票。加上其他达成临床开发、注册和商业化里程碑的付款，潜在总交易金额超过20亿 美元。此外，诺诚健华有权就授权产品的年度净销售额，收取最高达百分之十几的分级特许权使用费。 诺诚健华今年第二笔BD 2025年是中国创新药企业的BD大年。此次诺诚健华将奥布替尼及两项临床前资产有偿许可给Zenas，已 经是诺诚健华今年达成的第二笔BD，且延续了首笔BD"绑定股权" ...

智通财经记者 | 陈杨 智通财经编辑 | 谢欣 时隔两年半，国内创新药公司诺诚健华的BTK抑制剂奥布替尼重新出海。 10月8日盘后，诺诚健华公告称与纳斯达克上市公司Zenas（泽纳仕生物）签署授权协议，将奥布替尼及 2项临床前资产有偿许可给Zenas。该交易总额超20亿美元。其中Zenas将向诺诚健华支付总计1亿美元的 首付款和近期里程碑付款，并授予后者700万普通股股票，这约占Zenas已发行且流通普通股的9.3%。 10月9日开盘，诺诚健华A股股价高走，随后快速回落，收盘价报26.74元/股，跌6.24%，当下市值417.9 亿元。 具体而言，诺诚健华授予Zenas奥布替尼在多发性硬化症（MS）领域的全球独家权利、在非多发性硬化 症及非肿瘤适应症领域除大中华地区及东南亚地区以外区域的独家权利，以及一款临床前口服IL-17抑 制剂在除大中华地区及东南亚地区以外区域的独家权利、一款临床前口服透脑TYK2抑制剂的全球独家 权利。 相比之下，诺诚健华本次的交易对象并非大药企。Zenas当下尚无商业化阶段产品，市值约10亿美元。 智通财经则从前述业务沟通会上获悉，诺诚健华联合创始人、董事长兼CEO崔霁松提到，公司开 ...

诺诚健华年内签下的第二笔对外授权交易。 一笔超20亿美元的对外授权交易大单，不仅没有提振诺诚健华（688428.SH、09969.HK）股价，反而进 一步导致下跌。 与此同时，Zenas还获得诺诚健华另外两款临床前分子（一款新型口服IL-17 AA/AF抑制剂和一款透脑性 口服TYK2抑制剂）的相关权益。 在拿下上述三款自免药物权益后，Zenas10月8日（美东时间）股价大涨24.22%，走势与诺诚健华股价截 然不同。 诺诚健华股价下跌背后，有一些投资者在质疑Zenas的实力，同时认为整体交易获得的首付款低于预 期。 这是诺诚健华年内签下的第二笔对外授权交易。 10月9日上午开盘后，诺诚健华A股以及港股股价双双下挫，截至中午收盘时，A股股价跌6.91%，港股 股价跌9.68%。 前一晚，诺诚健华宣布与纳斯达克公司Zenas BioPharma（下称"Zenas"，ZBIO.US）达成重磅授权许可 协议，Zenas将获得奥布替尼在多发性硬化领域的全球开发和商业化权益，以及奥布替尼在非肿瘤的其 他治疗领域的开发与商业化权益。 根据协议条款，Zenas将向诺诚健华支付达1亿美元的首付款和近期里程碑付款，包括2026 ...

Summary of InnoCare Pharma (9969.HK) Conference Call Company Overview - **Company**: InnoCare Pharma (9969.HK) - **Partner**: Zenas BioPharma (ZBIO) - **Focus**: Global development of Orela (orelabrutinib) for multiple sclerosis (MS) and other non-oncology diseases Key Points Licensing Agreement with Zenas - InnoCare announced a licensing deal with Zenas for three assets, including: - Ex-China/Southeast Asia rights for orelabrutinib in MS and non-oncology diseases - Global rights for a preclinical oral brain-penetrant TYK2 inhibitor - A preclinical oral IL-17AA/AF inhibitor - Financial terms include: - Upfront cash payments of **US$100 million** - **7 million** new shares of Zenas upon achieving a milestone in early 2026 (valued at approximately **US$145 million** at **US$20.85/share**) - Development/regulatory/commercial milestone payments of up to **US$1.4 billion** - Tiered royalties on net sales [1][2][4] Clinical Development and Market Potential - Zenas is currently completing a phase 2 study on RMS for its core asset obexelimab but faces challenges in moving to phase 3 due to recruitment difficulties and financial constraints. - There is a higher chance for Zenas to prioritize Orela's phase 3 studies for PPMS and SPMS due to significant unmet medical needs, with a total addressable market (TAM) estimated at **US$12 billion** for PPMS and SPMS [4][5]. - Orela is noted for its best-in-class potential with high selectivity, CNS penetration, and low IC90, indicating high potency [4]. Execution and Recruitment Track Record - Zenas has demonstrated effective patient recruitment, completing enrollment of **93 patients** in about **9 months** for its phase 2 study, comparable to Roche's fenebrutinib study [4]. Financial Considerations - Zenas has a cash balance of **US$305 million** as of September, with a **US$120 million** raise and **US$100 million** payment due in 2025/2026 for the deal. - Additional funding may be required over the next three years to support ongoing and upcoming studies, including Orela's two phase 3 studies with a combined enrollment of approximately **1700 patients** [5]. Preclinical Assets - Zenas plans to start phase 1 on ZB021 (oral IL-17A/F inhibitor) in 2026, with preclinical data showing high potency. - ZB022, a brain-penetrant TYK2 inhibitor, is also in development, awaiting further data to validate its potential for neuroinflammatory and neurodegenerative diseases [6]. Earnings Forecast and Valuation Changes - Earnings forecasts for 2025E/2026E/2027E have been revised up by **Rmb116 million/Rmb204 million/Rmb204 million** due to the licensing deal. - The price target for InnoCare's H-Share has changed to **HK$22.89** (previously **HK$20.59**), and for the A-Share to **Rmb44.10** (previously **Rmb39.66**) [7][10]. Risks and Challenges - Key risks include R&D challenges for clinical assets, lack of a proven commercialization track record, pricing uncertainties, potential entry of generic ibrutinib in 2027 in China, and below-expected progress in global expansion [10]. Competitive Landscape - The competitive landscape for drugs targeting SPMS/PPMS includes Roche's Ocrevus and Sanofi's tolebrutinib, with limited competition for Orela in these indications [9]. Conclusion - The partnership with Zenas is seen as a strategic move for InnoCare to enhance the development of Orela in MS, with significant financial backing and market potential. However, careful monitoring of financial health and competitive dynamics will be essential for future success [1][4][10].

InnoCare Collaboration - Zenas BioPharma has a collaboration agreement with InnoCare Pharma, a biopharmaceutical company with a market cap exceeding $4.5 billion USD, two marketed products, and over 10 candidates in clinical development[9] - InnoCare will receive global rights to Orelabrutinib and ZB022, and global rights to ZB021 excluding China and Southeast Asia, while retaining global rights to Orelabrutinib in oncology indications[11] - Zenas will receive $35 million USD in cash and 5 million shares of Zenas common stock upfront from InnoCare[11] - Zenas is eligible for up to an additional 2 million shares of Zenas stock and up to $240 million USD in development and regulatory milestone payments for Orelabrutinib, as well as commercial sales milestone payments and tiered royalties on net sales[11] Orelabrutinib (BTKi) Program - A Phase 3 PPMS registration-directed trial has been initiated in the U S for Orelabrutinib, with a Phase 3 SPMS registration-directed trial expected to initiate in Q1 2026[11] - Orelabrutinib treatment in a Phase 2 RRMS trial resulted in a significant reduction in new GdE+ T1 lesions, with a >90% reduction observed at the 80mg QD dose at week 12 (P=0 0018)[48] - The global MS market is expected to exceed $30 billion USD, with SPMS and PPMS representing >$12 billion USD[61] Pipeline Programs - IND clearance and enrollment of the first patient for ZB021, an oral IL-17AA/AF inhibitor, and ZB022, a brain penetrant TYK2 inhibitor, are expected in 2026[11] - The anti-IL-17 biologics market is currently a $10 billion USD global market with ~50% average annual growth since first approval[74] Obexelimab Program - Phase 3 INDIGO trial for IgG4-RD is fully enrolled with topline results expected around year-end 2025[83] - Phase 2 MoonStone trial for RMS is fully enrolled with (12-week) data expected early Q4 2025[83] - Phase 2 SunStone trial for SLE is enrolling with (24-week) data expected mid-2026[83] - Obexelimab represents a compelling $1 billion+ USD commercial revenue opportunity in the U S alone for IgG4-RD[120]

Core Insights - Orelabrutinib is a potential best-in-class oral small molecule BTK inhibitor with strong CNS penetration, currently in global Phase III clinical development for progressive forms of multiple sclerosis (MS) [1][2][3] - A Phase III trial for primary progressive MS (PPMS) has been initiated, while a trial for secondary progressive MS (SPMS) is expected to start in Q1 2026 [1][2][6] - Zenas BioPharma has entered a significant licensing agreement with InnoCare Pharma, acquiring global rights for Orelabrutinib in MS and other non-oncological indications outside Greater China and Southeast Asia [1][11] Clinical Development - The Phase III trial for PPMS is a global, multicenter, randomized, double-blind, placebo-controlled study assessing the safety and efficacy of Orelabrutinib at a daily dose of 80 mg [2][6] - The SPMS Phase III trial is also designed as a global, multicenter, randomized, double-blind, placebo-controlled study, expected to start in Q1 2026 [6][14] - Previous Phase II trials demonstrated significant reductions in Gd+ T1 MRI brain lesions at 12 and 24 weeks, with sustained effects up to 96 weeks [2][4] Strategic Collaboration - The collaboration between InnoCare and Zenas is seen as a milestone in global development, enhancing the clinical and commercial value of Orelabrutinib [3][4] - Zenas aims to leverage this partnership to advance its pipeline, including two additional preclinical molecules: a novel oral IL-17AA/AF inhibitor and a CNS-penetrant oral TYK2 inhibitor, both expected to enter clinical trials in 2026 [3][7][8] Financial Terms - Under the licensing agreement, Zenas will pay InnoCare up to $100 million in upfront and milestone payments, with total transaction value exceeding $2 billion [11] - Zenas will also issue 7 million shares of common stock to InnoCare, along with tiered royalties based on annual net sales of the licensed products [11] Company Profiles - InnoCare Pharma is a biopharmaceutical company focused on innovative drug development for oncology and autoimmune diseases, with a strong pipeline of products at various stages [16] - Zenas BioPharma is a clinical-stage biopharmaceutical company dedicated to developing innovative therapies for autoimmune diseases, with a focus on Orelabrutinib and Obexelimab [17][18]

- Orelabrutinib, a highly selective CNS-penetrant, oral small molecule Bruton’s Tyrosine Kinase (BTK) inhibitor with best-in-class potential now in Phase 3 development for progressive forms of Multiple Sclerosis (MS) -  - Pivotal Phase 3 clinical trial evaluating orelabrutinib in patients with Primary Progressive MS (PPMS) initiated; Pivotal Phase 3 clinical trial in patients with Secondary Progressive MS (SPMS) expected to initiate in 1Q 2026 - - A novel oral IL-17AA/AF inhibitor, and an oral, brain-penetr ...

Obexelimab: A Differentiated B Cell Therapy - Obexelimab is a potentially highly differentiated I&I franchise molecule targeting autoimmune diseases [5] - It is the first bifunctional B cell targeting (CD19 x FcγRIIb) antibody in Phase 3 trial for IgG4-Related Disease and Phase 2 trials for RMS and SLE [6] - The company estimates a potential multi-billion-dollar commercial opportunity for Obexelimab [6, 45, 120] - Zenas BioPharma had approximately $314 million in cash as of Q1 2025, funding operations into Q4 2026 [6, 121] Clinical Development and Trial Readouts - Phase 3 topline results for the INDIGO trial in IgG4-RD are expected around year-end 2025 [46] - Phase 2 primary endpoint (12-week) data for the MoonStone trial in RMS is expected in early Q4 2025 [46] - Phase 2 primary endpoint (24-week) data for the SunStone trial in SLE is expected in mid-2026 [46] - The Phase 3 INDIGO trial in IgG4-RD has completed enrollment with approximately 190 patients [67] Market Opportunity and Strategic Collaboration - The estimated prevalence of IgG4-RD patients in the U S is approximately 20,000 to 40,000, and approximately 20,000 to 40,000 collectively in the UK, Germany, France, Italy, and Spain alone [52] - The company estimates that Obexelimab represents a compelling $1 billion+ commercial revenue opportunity in the U S alone for IgG4-RD [75] - Bristol Myers Squibb (BMS) has rights to develop and commercialize obexelimab in Japan, South Korea, Taiwan, Singapore, Hong Kong and Australia [47, 110]