机构：中金公司 研究员：张琎/杨一正/朱言音 首次覆盖 投资亮点 首次覆盖荃信生物-B（02509）给予跑赢行业评级，目标价33.00港元。理由如下： 端到端的创新药开发能力，自免领域深度布局。荃信生物成立于2015 年，作为国内少数几家专注于自 身免疫及过敏性疾病研发的Biotech，公司已搭建了从早研、生产到临床和商业化的端到端创新药开发 体系。截至目前公司已构建了覆盖皮肤/风湿/呼吸/消化科四大协同治疗领域的全面研发管线，已拥有了 1 款获批产品，10 款在研产品，以及20 余项IND批准。QX001S 是国内首个获批上市的乌司奴单抗生物 类似药，QX005N（IL-4Rα单抗）、QX002N（IL-17A 单抗）、QX004N（IL-23p19 单抗）均已处于III 期临床阶段，有望未来1-2 年也将上市贡献业绩。 自免双抗快速迭代，年内连续三次出海。基于公司在自免单抗领域的长期积累，公司高效开发了一系列 长效双抗产品，持续扩充管线中潜在FIC 及BIC 产品。2025 年公司就QX030N、QX031N（TSLP/IL- 33）和QX027N（TSLP/IL-13）分别与Caldera、Roche ...

Core Viewpoint - Junshi Biosciences has submitted its prospectus to the Hong Kong Stock Exchange, aiming to list on the biotech board under Chapter 18A, focusing on innovative cell therapies and drug development for solid tumors [1][3]. Group 1: Product Development - Junshi Biosciences is developing GC101, the world's first TIL therapy that does not require high-intensity lymphodepletion chemotherapy or IL-2 administration, and GC203, the first non-viral vector gene-modified TIL cell drug [1][3]. - Clinical data shows that GC101 has an objective response rate (ORR) of 41.7% in patients with metastatic non-small cell lung cancer (NSCLC) who failed standard treatment, and a 30% ORR in patients with advanced melanoma [1][3]. - GC101 is expected to be the first TIL therapy approved for market in China, with plans to submit a Biologics License Application (BLA) in 2026 [2][4]. Group 2: Clinical Trials and Efficacy - In a study of 12 patients with metastatic NSCLC, GC101 demonstrated a 66.7% overall survival rate at 12 months, with a median follow-up of 13 months [2][4]. - The clinical trial for GC101 in melanoma is currently in a critical Phase II trial, while the NSCLC pipeline is in Phase Ib [2][4]. - GC101 has shown potential in treating various other malignancies, including cervical cancer, cholangiocarcinoma, colorectal cancer, breast cancer, head and neck squamous cell carcinoma, sarcoma, and gallbladder cancer [2][4]. Group 3: Financial Overview - The company's R&D expenses were 57.62 million yuan in 2023, projected to increase to 90.99 million yuan in 2024, with 52.8 million yuan spent in the first half of 2025 [5]. - The R&D costs related to core products account for 46% of the total expenses [5].

Core Viewpoint - Changsen Pharmaceutical has completed a multi-hundred million RMB B+ round financing, led by Qiming Venture Partners, aimed at advancing key clinical research and global expansion [1] Company Overview - Changsen Pharmaceutical was founded in 2012 by renowned chemical drug research expert Wang Zhe, focusing on innovative drug development and commercialization in the fields of antiviral immunity, autoimmune diseases, and tumor immunotherapy [1] - The company has multiple indications entering clinical phases II and III, with core product clinical data reaching international leading levels [1] Product Highlights - The dual-functional, dual-target hepatitis B cure drug LW231 and the new generation autoimmune disease drug LW402 are expected to significantly meet clinical needs in their respective fields and may represent major breakthrough achievements [1]

Core Viewpoint - The China Securities Regulatory Commission (CSRC) has requested Tianchen Biopharma to provide supplementary information regarding its overseas listing application, focusing on fundraising estimates and shareholder transparency [1][2] Group 1: Regulatory Requirements - CSRC requires Tianchen Biopharma to clarify the expected fundraising amount after the full exercise of the over-allotment option [1][2] - The company must disclose the situation regarding its shareholders, specifically OFC Bohui Fund and OFC Jiazi Fund, after upward penetration [1] - Legal opinions are required to confirm the company's compliance with foreign investment policies and necessary qualifications for its business operations [1] Group 2: Company Overview - Tianchen Biopharma is a clinical-stage biopharmaceutical company focused on the development of innovative drugs for allergic and autoimmune diseases [2] - The company has established a comprehensive pipeline of biopharmaceutical products targeting various medical fields, including otolaryngology, dermatology, respiratory, hematology, nephrology, and other autoimmune diseases [2] - The growth of the global and Chinese markets for autoimmune and allergic diseases supports Tianchen Biopharma's ongoing reliance on its expertise in innovative drug development and strong R&D capabilities [2]

Core Viewpoint - Xuan Bamboo Biotech-B (02575.HK) is set to launch its global offering from October 6 to October 10, 2025, with a proposed share price of HKD 11.6 per share, aiming to raise funds for its innovative drug development in oncology and other fields [2] Group 1: Company Overview - Xuan Bamboo Biotech is one of the few high-tech biopharmaceutical companies in China that possesses capabilities in the development, industrialization, and commercialization of both small molecule drugs and large molecule biologics [2] - The company is focused on innovative drug development in areas such as oncology, digestive diseases, and NASH, with over ten drug assets currently under active development [2] Group 2: Financial Performance - The company reported revenues of RMB 29 million, RMB 300.9 million, RMB 65.1 million, and RMB 25.6 million for the years 2023, 2024, and the three months ending March 31, 2025, respectively, with all income derived from the commercialization of its drug KBP-3571 [2] - Research and development expenditures for the years 2023, 2024, and the three months ending March 31, 2025, were RMB 239.06 million, RMB 186.40 million, RMB 38.89 million, and RMB 53.04 million, respectively [3] - The company is currently operating at a loss, with net losses of RMB 300.6 million, RMB 556.4 million, RMB 111.0 million, and RMB 110.9 million for the years 2023, 2024, and the six months ending June 30, 2025, primarily due to the early stage of its commercialization strategy and operational expenses incurred during the reporting periods [3]

Group 1 - The core announcement involves a tripartite global licensing and collaboration agreement between a subsidiary of Hema Medical, Gilead Sciences, Inc., and Hanmi Pharmaceutical for the first P-glycoprotein inhibitor, encequidar, in the field of virology [1] - Hema Medical and Hanmi will grant Gilead global exclusive rights to encequidar in the virology field, while also providing drug supply, sharing technical knowledge, and participating as key partners in the project [1] - Upon meeting certain conditions and milestones during the agreement period, Hema Medical will receive an upfront payment of $10 million, with potential future payments reaching up to approximately $72.5 million, along with a low single-digit royalty on net sales [1] Group 2 - Hema Medical is primarily engaged in the development of innovative drugs in the oncology field and is currently researching oral formulations of encequidar [2] - The company is preparing to initiate a Phase 3 global clinical study for the treatment of metastatic breast cancer using oral paclitaxel combined with encequidar, aiming to replace intravenous administration of paclitaxel in chemotherapy [2] - The clinical study is planned to commence by the end of 2025 across multiple centers in the United States, Hong Kong, and New Zealand [2]

Group 1 - The core point of the news is that Hema Medical (希华医药) has entered into a global licensing and collaboration agreement with Gilead Sciences and Hanmi Pharmaceutical for the P-glycoprotein inhibitor encequidar, which Hema Medical holds exclusive global rights outside of South Korea [1] - Under the agreement, Hema Medical and Hanmi will grant Gilead exclusive global rights to encequidar in the field of virology, and they will also provide drug supply and share technical knowledge [1] - Hema Medical is set to receive an initial payment of $10 million, with potential future payments reaching up to approximately $72.5 million, along with a low single-digit royalty on net sales [1] Group 2 - Hema Medical is primarily focused on innovative drug development in the oncology field and is currently researching oral formulations of encequidar [2] - The company is preparing to initiate a Phase 3 global clinical study for the treatment of metastatic breast cancer using oral paclitaxel combined with encequidar, which aims to replace intravenous administration of paclitaxel in chemotherapy [2] - The clinical study is planned to commence by the end of 2025 across multiple centers in the United States, Hong Kong, and New Zealand [2]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不 負 責，對 其 準 確 性 或 完 整 性 亦 不 發 表 任 何 聲 明，並 明 確 表 示，概 不 對 因 本 公 告 全部或任何部分內容而產生或因倚賴該等內容而引致的任何損失承擔任何責 任。 （股份代號：3309） （於開曼群島註冊成立之有限公司） 自願性公告 最新業務進展 希 瑪 醫 療 控 股 有 限 公 司（「本公司」，連 同 其 附 屬 公 司 統 稱「本集團」）董 事 會（「董 事 會」）欣 然 宣 佈，於2025年9月29日，希 華 醫 藥 有 限 公 司（「希華醫藥」）的 一 間 附 屬公司與Gilead Sciences, Inc.（「Gilead」）及 韓 美 藥 品 工 業 株 式 会 社（「韓 美」）就 病 毒 學領域首款P－糖 蛋 白（「P-gp」）抑 制 劑encequidar（希 華 醫 藥 擁 有 該 款 藥 物 在 韓 國 以 外 的 全 球 獨 家 權 利）訂 立 三 方 全 球 授 權 及 合 作 協 議。 根 據 協 議，希 華 醫 藥 及 韓 美 會 將encequidar在病毒學領域的全球獨家權 ...

Core Viewpoint - Zhejiang Haizheng Pharmaceutical Co., Ltd. has signed an exclusive licensing and strategic cooperation agreement with Shenzhen Aixin Dawei Pharmaceutical Technology Co., Ltd. to enhance its innovation drug development capabilities and create new value growth points [1][3]. Group 1: Licensing Agreement - The agreement grants Haizheng exclusive rights to the globally innovative small molecule prodrug AST-3424 within the specified regions, including mainland China, Hong Kong, and Macau [1]. - Haizheng is authorized to research, develop, register, produce, and commercialize the licensed product, and will be the sole applicant for market approval in the cooperation area [1][3]. - A non-competition clause prohibits Aixin Dawei and its affiliates from engaging in competitive activities in the cooperation area during the agreement's term [2]. Group 2: Financial Terms - Haizheng will pay an upfront fee and milestone payments totaling no more than 240 million RMB based on the achievement of development milestones [3]. - Upon the product's first approval for sale in the cooperation area, Haizheng will pay annual royalties based on a percentage of net sales and milestone bonuses based on annual sales performance [4]. Group 3: Strategic Cooperation on AKR1C3 Enzyme Activation Platform - The agreement includes a strategic cooperation on Aixin Dawei's AKR1C3 enzyme activation platform, with a two-year option period for Haizheng to exercise its rights [5]. - Aixin Dawei is responsible for developing specified drugs using the AKR1C3 platform and advancing them to obtain clinical trial approval in mainland China [5]. - Any intellectual property developed during the cooperation will be exclusively owned or licensed to Haizheng [5][6]. Group 4: Charitable Donation - Haizheng's subsidiary, Huizheng (Shanghai) Pharmaceutical Technology Co., Ltd., will donate 200,000 RMB to support a prostate screening charity project in Nanjing [7]. - The donation is made from the company's own funds and does not significantly impact current or future performance [7].

Group 1 - The China Securities Regulatory Commission has approved XuanZhu Biotechnology Co., Ltd. to issue up to 77,433,500 overseas listed ordinary shares and list them on the Hong Kong Stock Exchange [1] - A total of 17 shareholders plan to convert 93,368,496 shares of unlisted domestic shares into overseas listed shares for circulation on the Hong Kong Stock Exchange [1] Group 2 - XuanZhu Biotechnology is a Chinese biopharmaceutical company with over ten drug assets actively under development, focusing on diseases with significant unmet medical needs, including gastrointestinal diseases, tumors, and non-alcoholic fatty liver disease (NASH) [3][4] - The company has three core products: KBP-3571 (NDA approved for gastrointestinal diseases), XZP-3287 (NDA approved for targeted breast cancer), and XZP-3621 (NDA submitted for targeted non-small cell lung cancer) [3][4] - The company employs a phased development strategy for each key indication, with KBP-3571 currently expanding its indication coverage to include gastroesophageal reflux disease after completing Phase II clinical trials [4]