编辑丨王多鱼 排版丨水成文 肿瘤免疫疗法 一直是一种很有前景的治疗方法，其在摧毁肿瘤方面卓有成效，尤其是在抑制肿瘤转移方面。在不同类型的免疫疗法中，基于 PD-1/PD-L1 调控 通路的免疫检查点阻断 （ICB） 疗法在治疗几种晚期癌症方面取得了巨大成功，通过缓解免疫抑制性肿瘤微环境发挥作用。然而， ICB 疗法在癌症治疗中的效果 和广泛应用受到了应答率不足的限制。 幸运的是，研究人员发现， Gasdermin D 介导的 细胞焦亡 （ Pyroptosis ） 可引发强烈且有效的全身性免疫反应 ，仅 15% 经历细胞焦亡的肿瘤细胞就能消除 整个肿瘤，这为增强抗肿瘤免疫提供了一种很有前景的策略。 光动力疗法 （PDT） 和 化疗 能够有效诱导细胞焦亡，但前者存在光穿透性差的问题，后者则面临耐药性难题。此外，传统的自发光光动力疗法依赖于肿瘤微环 境 （TME） 中的内源性过氧化氢 （H₂O₂） 和氧气 （O₂） ，导致治疗效果不佳。 2025 年 12 月 23 日，北京大学第三医院 梁晓龙 团队在 Cell 子刊 Cell Biomaterials 上发表了题为： Camptothecin amplifie ...

Core Viewpoint - Hanse Aitai Biopharmaceutical Technology (Wuhan) Co., Ltd. successfully listed on the Hong Kong Stock Exchange, marking it as the second company from Wuhan to go public under the HKEX's 18A biotech rules. The company focuses on developing innovative drugs for cancer and autoimmune diseases, addressing unmet medical needs in these areas [3][4]. Group 1: IPO Details - Hanse Aitai issued 18.321 million H-shares at an offering price of HKD 32 per share, raising a total of HKD 586 million, with a market capitalization of nearly HKD 4.4 billion at issuance [3]. - On its first trading day, the opening price was HKD 28.9, and the latest market capitalization was HKD 3 billion [3]. - The company has completed three rounds of financing prior to the IPO, totaling approximately RMB 154 million, with major investors including Betta Pharmaceuticals and Longpan Investment [4]. Group 2: Product Pipeline and R&D Focus - The core product, HX009, is the world's only PD-1/SIRPα dual-function antibody fusion protein, currently in Phase II clinical trials in China after completing Phase I trials in China and Australia [4][20]. - Another innovative product, HX044, has initiated Phase I clinical trials for advanced solid tumors in both China and Australia [4][21]. - The company plans to allocate approximately 35% of the raised funds to advance HX009, 33% to develop HX301 and HX044, and 5% for commercialization preparations [4]. Group 3: Founder's Background and Company Development - Founder Zhang Faming, who has a strong academic and professional background in biochemistry and pharmaceutical development, has previously founded and sold successful biotech companies [10][11]. - Hanse Aitai was established in 2014 and has since focused on developing next-generation immunotherapies, particularly targeting the limitations of existing PD-1 therapies [15][17]. - The company has built a robust R&D team, integrating expertise from various fields to enhance its drug development capabilities [15][20]. Group 4: Market Context and Competitive Landscape - The global PD-1/PD-L1 antibody market is projected to reach USD 53.7 billion by 2024, with expectations to grow to USD 72.5 billion by 2030, highlighting the competitive nature of the immunotherapy sector [25]. - Hanse Aitai's dual-target design for HX044 aims to address the challenges of PD-1 resistance, positioning the company in a competitive landscape with several other firms pursuing similar therapeutic strategies [26][28]. - The company is one of the few globally to have two clinical-stage products targeting the SIRPα pathway, indicating significant long-term collaboration potential [28].

Company Overview - Junshi Biosciences Co., Ltd. (君赛生物) has submitted a listing application to the Hong Kong Stock Exchange, with CITIC Securities acting as the sole sponsor [1] - The company focuses on innovative cell therapies and drug development for solid tumors, aiming to provide safer, more effective, and affordable immunotherapy options [3][4] Product Information - The core product, GC101, is the world's first tumor-infiltrating lymphocyte (TIL) therapy that does not require high-intensity lymphodepletion or IL-2 administration, potentially becoming the first TIL therapy approved in China [3][4] - Clinical trials have shown that GC101 can provide objective response rates of 30% for metastatic melanoma and 41.7% for non-small cell lung cancer, with a median progression-free survival of 5.5 months for melanoma patients [4] Financial Performance - The company reported revenues of RMB 6.812 million, RMB 3.372 million, and RMB 6.830 million for the fiscal years ending June 30, 2023, 2024, and 2025, respectively [5] - Losses for the same periods were RMB 94.391 million, RMB 163.652 million, and RMB 97.580 million, indicating significant financial challenges [6][7] Market Overview - The global oncology drug market is projected to grow to USD 253.3 billion by 2024, with a compound annual growth rate (CAGR) of 13.9% from 2020 to 2024 [8] - The Chinese oncology drug market is expected to reach RMB 258.2 billion by 2024, with a CAGR of 6.9% during the same period [11] TIL Therapy Market - The global TIL therapy market is anticipated to grow from USD 10.4 million in 2024 to USD 1.692 billion by 2030, with a CAGR of 59.3% from 2024 to 2028 [14] - In China, the TIL therapy market is expected to reach USD 200 million by 2030, with a CAGR of 40.0% from 2030 to 2035, outpacing global growth rates [14][17] Board of Directors - The board consists of 9 members, including 4 executive directors, 2 non-executive directors, and 3 independent non-executive directors, with a term of 3 years [18] Shareholding Structure - As of December 5, 2025, Dr. Jin holds a 34.5% stake in the company, with other significant shareholders including Kai Tai Capital and Yuan He Yuan Dian [21][23]

Core Viewpoint - Junsei Biotech has submitted its listing application to the Hong Kong Stock Exchange, with CITIC Securities as its sole sponsor [1] Company Overview - Junsei Biotech focuses on innovative cell therapies and drug development for solid tumors, aiming to create safer, more effective, and affordable immunotherapy options [3] - The company's core product, GC101, is the world's first tumor-infiltrating lymphocyte (TIL) therapy that does not require high-intensity lymphodepletion or IL-2 administration, potentially becoming the first TIL therapy approved in China [3][4] - GC101 has shown objective response rates of 30% in advanced melanoma and 41.7% in advanced non-small cell lung cancer patients who failed standard treatments [4] Financial Performance - Revenue for the fiscal years ending June 30, 2023, 2024, and 2025 was recorded at RMB 6.812 million, RMB 3.372 million, and RMB 6.830 million, respectively [5] - The company reported losses of RMB 94.391 million, RMB 163.652 million, and RMB 97.580 million for the same periods [6][7] Industry Overview - The global oncology drug market is projected to grow to USD 253.3 billion by 2024, with a compound annual growth rate (CAGR) of 13.9% from 2020 to 2024 [8] - The Chinese oncology drug market is expected to reach RMB 258.2 billion in 2024, with a CAGR of 6.9% from 2020 to 2024 [11] - The TIL therapy market is anticipated to grow significantly, reaching USD 1.04 billion in 2024 and USD 16.92 billion by 2030, with a CAGR of 59.3% from 2024 to 2028 [14][17] Clinical and Regulatory Landscape - The TIL therapy market is expected to expand rapidly due to clinical, technical, regulatory, and funding support, with promising results in various solid tumors [17] - GC101 is currently undergoing critical Phase II clinical trials for melanoma and is in Phase I for non-small cell lung cancer, with plans to submit a Biologics License Application (BLA) by 2026 [4]

Investment Rating - The report assigns an "Accumulate" rating for the company, marking its first coverage [1]. Core Insights - The company positions itself as a leader in next-generation tumor immunotherapy, leveraging three major technology platforms to establish a high-quality R&D pipeline [3][12]. - The 4-1BB co-stimulation signal market shows significant potential, with the product LBL-024 demonstrating notable competitive advantages [4][25]. - The TCE technology platform has been validated through clinical data, with LBL-034 showing superior efficacy and safety compared to competitors [5][22]. - The company is currently in the new drug development investment phase, with projected revenues of 175 million, 314 million, and 187 million yuan for 2025, 2026, and 2027 respectively, and expected net losses of 200 million, 99 million, and 262 million yuan [5]. Summary by Sections Section 1: Three Platforms Supporting Next-Generation Tumor Immunotherapy - The company aims to address diseases that current therapies, such as PD-1/PD-L1 antibodies, cannot treat, focusing on cutting-edge targets like 4-1BB and PD-L1 dual targets [3][12]. - The R&D team is robust, with extensive experience in new drug development, and has established a pipeline of 14 new drugs, including 6 in clinical stages and 4 with leading global clinical progress [13][22]. Section 2: 4-1BB Co-Stimulation Signal Market Potential - 4-1BB serves as a co-stimulation immune checkpoint molecule, providing a second signal for T-cell activation [25][31]. - LBL-024, a low-affinity 4-1BB dual antibody, has shown excellent efficacy and safety balance in clinical trials, with significant improvements in overall survival compared to existing treatments [4][35]. Section 3: TCE Technology Platform Validation - The TCE platform, particularly the CD3 TCE drug LBL-034, has demonstrated the ability to conditionally activate T-cells in tumor microenvironments, showing advantages in safety and efficacy over similar products [5][22]. - The company has plans for new generation TCE and TCE ADC platforms, with the CD3/MUC16 TCE positioned among the top globally [5][22].

Core Viewpoint - The completion of patient enrollment in the Phase III clinical trial of BA1104 (Nivolumab injection) by the company marks a significant milestone, as it is the first biosimilar of Opdivo to enter Phase III trials in China [1][2] Group 1: Company Developments - BA1104 is a humanized monoclonal antibody targeting the PD-1 receptor, designed to enhance T-cell anti-tumor responses by blocking the interaction between PD-1 and its ligands PD-L1 and PD-L2 [1] - The Phase III trial is a randomized, double-blind, multi-center study comparing the efficacy, safety, and immunogenicity of BA1104 with Opdivo in combination with chemotherapy for patients with advanced or metastatic esophageal squamous cell carcinoma [2] - The results of the completed Phase I trial indicated that BA1104 is highly comparable to Opdivo in terms of pharmacokinetics, safety, and immunogenicity, achieving all study endpoints [2] Group 2: Market Potential - The PD-1 inhibitors, including BA1104, represent a major advancement in cancer immunotherapy, with expanding clinical applications and significant market potential [2] - Opdivo is projected to generate approximately $9.3 billion in global sales in 2024 [2] - The Chinese antibody market based on PD-1/L1 is expected to reach 59.9 billion RMB by 2030, indicating substantial growth opportunities in this sector [2]

Core Viewpoint - The company has completed patient enrollment for the Phase III clinical trial of BA1104 (Nivolumab Injection) in China, making it the first biosimilar of Opdivo to enter Phase III trials domestically [1][2] Company Summary - BA1104 is a humanized monoclonal antibody (IgG4 subtype) targeting the programmed cell death protein 1 (PD-1) receptor, enhancing T-cell anti-tumor responses by blocking the interaction between PD-1 and its ligands PD-L1 and PD-L2 [1] - The Phase III trial is a randomized, double-blind, multi-center study comparing the efficacy, safety, and immunogenicity of BA1104 combined with chemotherapy against Opdivo in patients with advanced or metastatic esophageal squamous cell carcinoma [2] - The completed Phase I trial results indicate that BA1104 is highly comparable to Opdivo in terms of pharmacokinetics, safety, and immunogenicity, achieving all study endpoints, with results published in the international journal "BioDrugs" [2] Industry Summary - PD-1 inhibitors represent a major approach in cancer immunotherapy, with ongoing breakthroughs in combination therapies and the synergistic development of diverse immunotherapies expanding their clinical application boundaries [2] - The global sales of Opdivo are projected to reach approximately $9.3 billion in 2024 [2] - According to a Frost & Sullivan report, the market size for PD-1/L1 antibodies in China is expected to reach 59.9 billion RMB by 2030 [2]

Core Viewpoint - The company announced the completion of patient enrollment for the Phase III clinical trial of BA1104 (Nivolumab Injection) in China, marking it as the first biosimilar of Opdivo® to enter Phase III trials domestically [1][2] Group 1: Product Development - BA1104 is a humanized monoclonal antibody targeting the PD-1 receptor, designed to enhance T-cell anti-tumor responses by blocking the interaction between PD-1 and its ligands PD-L1 and PD-L2 [1] - The Phase III trial is a randomized, double-blind, multi-center study comparing the efficacy, safety, and immunogenicity of BA1104 combined with chemotherapy against Opdivo® in patients with advanced or metastatic esophageal squamous cell carcinoma [2] - The completed Phase I trial results indicate that BA1104 is highly comparable to Opdivo® in terms of pharmacokinetics, safety, and immunogenicity, achieving all study endpoints [2] Group 2: Market Potential - PD-1 inhibitors, including BA1104, represent a significant advancement in cancer immunotherapy, with expanding clinical applications and market potential [2] - Opdivo® is projected to generate global sales of approximately $9.3 billion in 2024 [2] - The antibody market in China based on PD-1/L1 is expected to reach RMB 59.9 billion by 2030, indicating substantial growth opportunities [2]

（股 份 代 號：6955） 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 就 因 本 公 告 的全部或任何部份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。 Shandong Boan Biotechnology Co., Ltd. 山東博安生物技術股份有限公司 （於 中 華 人 民 共 和 國 註 冊 成 立 的 股 份 有 限 公 司） 自願性公告 本公司納武利尤單抗中國Ⅲ期臨床試驗完成所有患者入組 山東博安生物技術股份有限公司（「本公司」）董事會（「董事會」）宣 佈，本 公 司 自 主開發的BA1104（納 武 利 尤 單 抗 注 射 液）在中華人民共和國（「中 國」）的Ⅲ期臨床 試 驗 已 完 成 所 有 患 者 入 組。BA1104開 發 進 度 領 先，為 國 內 首 個 開 展 Ⅲ 期 臨 床 試 驗的歐狄沃® （Opdivo®）生 物 類 似 藥。 納武利尤單抗是一種針對程序性細胞死亡1（「PD-1」）受體的人源化單克隆抗體 （IgG4亞 型），通 過 ...

Core Insights - The company reported strong sales growth for the first nine months of 2025, prompting an upward revision of its full-year financial guidance [1][2] - The CEO highlighted robust performance across three therapeutic areas, with increasing contributions from the rare liver disease segment [1] - The company is optimistic about the Phase II LANTIC trial data for its innovative long-acting molecule IPN10200 in the aesthetic medicine sector [1] Financial Performance - For the first nine months of 2025, the company achieved a year-on-year sales growth of approximately 10.0%, up from a previous expectation of over 7.0% [2] - The company has adjusted its full-year financial guidance based on strong performance metrics [2] Acquisition Details - The company signed a final equity acquisition agreement to acquire ImCheck Therapeutics, a French biotech firm focused on next-generation cancer immunotherapy [2] - The acquisition centers on the ICT01 project, which targets acute myeloid leukemia (AML) and is expected to enter Phase IIb/III trials in 2026 [2] - The deal includes an upfront cash payment of €350 million, with additional payments contingent on regulatory approvals and sales milestones [2]