Core Viewpoint - The Hong Kong pharmaceutical sector experienced a significant decline on October 9, with the Hang Seng Biotechnology Index dropping over 5%, influenced by external factors such as U.S. tariff announcements on pharmaceutical products [1][3]. Group 1: Market Performance - The Hang Seng Hong Kong Stock Connect Innovative Drug ETF (520880) saw a decline of over 1% after initially opening up 1.75% [1]. - The Hang Seng Hong Kong Stock Connect Innovative Drug Selected Index recorded a weekly increase of 6.54% during the previous week, reflecting a positive trend before the recent downturn [1]. - Notable declines were observed in key stocks, with Innovent Biologics and China Biologic Products falling over 8% and 7% respectively [1]. Group 2: External Influences - U.S. President Trump's announcement on September 25 regarding a 100% tariff on pharmaceutical products without U.S. manufacturing facilities starting October 1, 2025, has raised concerns for Chinese innovative drug companies heavily reliant on the U.S. market [1][3]. - Southwest Securities predicts that companies with direct export capabilities to the U.S. without local manufacturing will face short-term pressure, while those utilizing business development (BD) strategies will be less affected [3]. Group 3: Future Outlook - Upcoming industry conferences, such as ESMO (October 17-21) and ASH (December), are expected to serve as catalysts for the innovative drug sector [3]. - The fourth quarter will see the implementation of domestic policy changes, including adjustments to the medical insurance catalog, which may impact the sector positively [3]. - The fund manager of the Hong Kong Stock Connect Innovative Drug ETF (520880) indicated that the current market adjustment could present a buying opportunity for high-quality innovative drug companies [3]. Group 4: ETF Characteristics - The Hong Kong Stock Connect Innovative Drug ETF (520880) is the first ETF tracking the Hang Seng Hong Kong Stock Connect Innovative Drug Selected Index, focusing exclusively on innovative drug R&D companies [4]. - The index has shown a year-to-date increase of 119.75%, outperforming other innovative drug indices, and aims to avoid the influence of contract research organizations (CROs) on its performance [5].

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].

Core Viewpoint - The Hong Kong stock market experienced a decline, with the Hang Seng Index falling by 0.6% and the Hang Seng Tech Index decreasing by 0.22% [1] Group 1: Market Performance - The pharmaceutical sector faced significant losses, with notable declines in specific companies [1] - Nocera Healthcare and SiHuan Pharmaceutical both dropped over 8% [1] - China Biologic Products and Hansoh Pharmaceutical saw declines exceeding 4% [1]

每经AI快讯，10月9日，港股创新药板块普遍回调，四环医药、诺诚健华跌超8%，科伦博泰生物跌超 6%，信达生物跌超5%。 ...

Group 1 - The core point of the news is that Nocera Biopharma's stock price dropped by 5.33% to 27.00 CNY per share, with a trading volume of 305 million CNY and a turnover rate of 3.99%, resulting in a total market capitalization of 47.645 billion CNY [1] - Nocera Biopharma, established on November 3, 2015, and listed on September 21, 2022, focuses on the research, production, and commercialization of biopharmaceuticals, particularly in oncology and autoimmune diseases [1] - The company's revenue composition includes 87.67% from drug sales, 12.04% from technology licensing, and 0.15% each from testing and research services [1] Group 2 - Dongzheng Asset Management has a fund that heavily invests in Nocera Biopharma, with the "Oriental Red Medical Upgrade Stock Initiation A" fund reducing its holdings by 865,300 shares, now holding 2.6276 million shares, which represents 4.55% of the fund's net value [2] - The fund has experienced a floating loss of approximately 3.9939 million CNY due to the reduction in holdings [2] - The "Oriental Red Medical Upgrade Stock Initiation A" fund was established on March 29, 2022, with a current size of 481 million CNY, achieving a year-to-date return of 76.91% and a one-year return of 67.24% [2]

消息面上，诺诚健华发布公告称，公司的全资子公司InnoCare Pharma Inc.与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该等产品。Zenas将向公司支付1亿美元的首付 款和近期里程碑付款，包括预计在2026年实现里程碑时支付的现金，以及授予公司700万普通股股票， 包括预计在2026年初实现里程碑时发行的股票。本次交易首付款及近期里程碑付款，潜在的研发及注册 里程碑付款，以及潜在的商业化里程碑付款总额合计超过20亿美元。此外，公司有权按许可产品年度净 销售额收取最高达高百分之十几的分层特许权使用费。 北京商报讯（记者 丁宁）10月9日，诺诚健华（688428）高开10.17%，开盘价为31.42元/股。 ...

Core Insights - Nocera Biopharma experienced a stock price increase of 9.99%, reaching 31.37 CNY per share, with a trading volume of 113 million CNY and a turnover rate of 1.40%, resulting in a total market capitalization of 55.357 billion CNY [1] Company Overview - Nocera Biopharma, established on November 3, 2015, and listed on September 21, 2022, is based in Beijing, China. The company focuses on the research, production, and commercialization of biopharmaceuticals, particularly in oncology and autoimmune diseases, addressing unmet clinical needs [1] - The company's product pipeline includes ICP-022, ICP-B04, ICP-490, ICP-192, and ICP-723, among others. Its primary business operations are conducted in China and the United States [1] - Revenue composition is as follows: 87.67% from drug sales, 12.04% from technology licensing, and 0.15% each from testing and research services [1] Fund Holdings - According to data, one fund under ICBC Credit Suisse holds a significant position in Nocera Biopharma. The fund, ICBC Credit Suisse Zhaorui One-Year Holding Mixed A (014799), held 119,500 shares in the second quarter, accounting for 0.82% of the fund's net value, ranking as the tenth largest holding [2] - The fund has a current scale of 319 million CNY and has achieved a year-to-date return of 13.65%, ranking 5569 out of 8238 in its category. Over the past year, it has returned 17.39%, ranking 4651 out of 8082, and since inception, it has returned 16.59% [2] Fund Manager Information - The fund manager of ICBC Credit Suisse Zhaorui One-Year Holding Mixed A is Zhao Jian, who has been in the position for 3 years and 235 days. The total asset size of the fund is 17.478 billion CNY, with the best return during his tenure being 16.35% and the worst being 0.08% [3]

Policy Developments - The National Healthcare Security Administration (NHSA) has initiated a crackdown on "returning drugs" through a "100-day action" plan, emphasizing comprehensive regulation across all stages of the drug supply chain [2] - The NHSA aims to enhance intelligent regulatory systems to preemptively manage healthcare fund oversight [2] Drug and Device Approvals - The FDA has approved Boehringer Ingelheim's small molecule tablet Jascayd (nerandomilast) for the treatment of idiopathic pulmonary fibrosis (IPF), marking the first new therapy for IPF in over a decade [5] - Roche and Jazz Pharmaceuticals received FDA approval for the PD-L1 inhibitor Tecentriq (atezolizumab) in combination with Zepzelca (lurbinectedin) as a first-line maintenance treatment for extensive-stage small cell lung cancer (ES-SCLC) [6] - Northeast Pharmaceutical announced that its DCTY0801 injection has received clinical trial approval for treating EGFRvIII positive recurrent or progressive high-grade glioma [7] - BaiLi Tianheng has received clinical trial approval for its innovative drug BL-ARC001 for advanced solid tumors, which is a first-in-class antibody-drug conjugate [9] Capital Markets - Chengyi Biotechnology has submitted a listing application to the Hong Kong Stock Exchange, with Jefferies, BofA Securities, and CICC as joint sponsors [11] - Changfeng Pharmaceutical's IPO on the Hong Kong Stock Exchange saw a significant opening increase of over 218%, trading at HKD 47 per share [12] Industry Developments - Innovent Biologics has entered into a licensing agreement with Zenas BioPharma for three autoimmune pipeline products, including a USD 100 million upfront payment and potential milestone payments exceeding USD 2 billion [14] - AstraZeneca has signed a USD 555 million collaboration agreement with Algen Biotechnologies to leverage AI for discovering new therapeutic targets in immunology [16][17]

Core Viewpoint - The company announced a licensing agreement with Zenas for its core product, Orelabrutinib, in the field of multiple sclerosis and other non-oncological treatments, while retaining rights in oncology [1][2]. Group 1: Licensing Agreement Details - The agreement includes a $100 million upfront payment and potential milestone payments, with a total deal value exceeding $2 billion [1]. - Zenas will also issue 7 million shares of common stock to the company, with additional payments tied to clinical development and commercialization milestones [1]. - The agreement allows Zenas to develop and commercialize Orelabrutinib globally for multiple sclerosis and other non-cancer indications [1][2]. Group 2: Product and Market Insights - Orelabrutinib is currently approved for three indications in hematological cancers in China, with ongoing clinical trials for multiple sclerosis [2]. - The company retains exclusive global rights for Orelabrutinib in oncology, establishing a dual strategy of self-research in oncology and licensing in autoimmune diseases [2]. - The new oral IL-17 AA/AF inhibitor and the brain-penetrant oral TYK2 inhibitor are in preclinical stages, targeting autoimmune diseases like psoriasis and psoriatic arthritis [3]. Group 3: Market Context and Future Prospects - The global market for multiple sclerosis treatments is significant, particularly in Europe and North America, where the disease has a higher prevalence [5]. - The company’s Orelabrutinib shows advantages in kinase selectivity and binding affinity, indicating strong clinical development potential [5]. - The oral IL-17 AA/AF inhibitor addresses the challenge of injection-based therapies, which may improve patient compliance [5]. Group 4: Financial Position - As of June 30, 2025, the company holds approximately 7.68 billion yuan in cash and equivalents, indicating a strong financial position within the biotech sector [6].

以下文章来源于invest wallstreet ，作者创新药君 invest wallstreet . 寻找下一个英伟达 Zenas BioSciences与中国的诺诚健华达成一项超过20亿美元的合作，截止周三收盘，Zenas 股票大涨 24.22%。 Zenas BioSciences 与中国北京的 InnoCare Pharma（诺诚健华）达成一项超 20 亿美元的全球授权协 议，获得三款自身免疫病候选药物权益，其中包括曾被 Biogen 放弃的 BTK 抑制剂 orelabrutinib。这 一交易也印证了 2025 年跨国药企与中国生物公司合作的热潮 —— 仅上半年行业合作金额就已超 2024 年全年。 尽管Zenas认为obexelimab在I&I领域有广泛的潜力，但公司目前专注于四个适应症：免疫球蛋白G4相关 疾病（IgG4-RD）、多发性硬化症、系统性红斑狼疮和温抗体自身免疫性溶血性贫血（wAIHA）。其 中，IgG4-RD的3期临床试验进展最为深入，这是一种影响多个器官的慢性炎症状况，目前的标准治疗包 括皮质类固醇和罗氏公司的CD20靶向抗体药物Rituxan。 根据双方 10 月 8 日公 ...