SHR-4298注射液是公司自主研发的1类治疗用生物制品，在临床前动物模型中展现出良好的抗肿瘤活 性，拟用于治疗晚期实体瘤。经查询，目前国内外尚无同类药物获批上市。截至目前，SHR-4298注射 液相关项目累计研发投入约2,879万元。 恒瑞医药（600276）(600276.SH)发布公告，近日，公司子公司苏州盛迪亚生物医药有限公司收到国家 药品监督管理局(简称"国家药监局")核准签发关于SHR-4298注射液的《药物临床试验批准通知书》，将 于近期开展临床试验。 ...

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of HRS-7172 tablets, a new type of anti-tumor small molecule inhibitor, with no similar drugs approved for market domestically or internationally [1] Group 1 - The company has developed HRS-7172 tablets, which are a novel anti-tumor small molecule inhibitor [1] - The approval for HRS-7172 marks a significant milestone as there are currently no similar drugs available in the market [1] Group 2 - The company's subsidiary, Suzhou Shengdiya Biopharmaceutical, has also received approval for clinical trials of SHR-A2009 injection, an antibody-drug conjugate targeting HER3 [1] - SHR-A2009 specifically binds to HER3 on the surface of tumor cells, leading to internalization and release of cytotoxic agents within the cells [1] - There are no similar drugs approved globally for SHR-A2009, indicating a unique position in the market [1]

Summary of Junshi Biosciences Conference Call Company Overview - **Company**: Junshi Biosciences - **Date**: August 27, 2025 Key Financial Performance - **R&D Expenses**: CNY 706 million, up 29% YoY [2] - **Sales Expense Ratio**: Decreased to below 50% [2] - **Management Expenses**: Decreased by 19% YoY to CNY 195 million [2] - **Net Loss**: Decreased by 36% YoY to CNY 413 million [3] - **Revenue**: CNY 1.168 billion, up 49% YoY [3] - **Core Product Revenue**: Core product Tuoyi generated CNY 954 million, up 42% YoY [3] - **Funding**: Completed nearly CNY 1 billion in Hong Kong stock placement, ensuring good financial health for future R&D and business expansion [2] Product Development and Market Expansion - **Core Product - Toripalimab**: - New indications approved for first-line treatment of melanoma and combination therapy with Bevacizumab for advanced liver cancer [2][4] - Total of 12 approved indications in China, with 10 included in the national medical insurance directory [4] - Sales in the first half of 2025 approached CNY 1 billion, driven by policy support, governance improvements, market expansion, and academic promotion [3][14] - **Pipeline Projects**: - **GS207 (PD-1/VEGF Dual Antibody)**: Currently in Phase II clinical trials for various cancers [5] - **BTLA Antibody**: Phase III global multi-center study for small cell lung cancer expected to complete enrollment by 2026 [5] - **JT002**: A CPG oligodeoxynucleotide for allergic rhinitis, submitted for Phase III registration, showing potential for international markets [6] - **GS212 (EGFR ADC)**: In Phase I dose escalation, showing good safety profile [18] Clinical Trials and Research Progress - **Clinical Trials**: Multiple ongoing Phase III trials for Toripalimab in esophageal cancer, gastric cancer, and cholangiocarcinoma [25] - **Expected Data Readouts**: - Combination therapy for liver cancer expected by late 2025 or early 2026 [25] - Esophageal cancer data expected in Q3 or Q4 of 2026 [25] Strategic Focus and Future Directions - **Operational Strategy**: Focus on quality improvement, cost reduction, and efficiency enhancement to meet global market demands [7] - **R&D Resource Allocation**: Prioritizing key products in clinical validation stages, including dual antibodies and ADCs [13] - **Market Expansion**: Plans to enhance commercialization efforts and expand into new markets, with significant growth in overseas sales [16] Regulatory and Market Considerations - **Regulatory Environment**: Positive impact from national medical insurance policies and compliance guidelines on product growth [14] - **Sales Growth Drivers**: Increased market share due to new indications and improved governance and management practices [14][17] Conclusion - **Investment Potential**: Junshi Biosciences shows strong growth potential with a robust pipeline, strategic market expansion, and improved financial health, making it a noteworthy company for investors to monitor [26]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of HRS-6093, a novel oral KRAS G12D inhibitor, which is expected to have significant anti-tumor effects [1] Group 1: Product Development - HRS-6093 is a new, efficient, and selective oral KRAS G12D inhibitor that specifically binds to the KRAS G12D mutant protein [1] - There are currently no similar products approved for sale in both domestic and international markets [1] - The total research and development investment for HRS-6093 has reached approximately 29.84 million yuan [1]

Core Viewpoint - Heng Rui Medicine (01276.HK) has received approval from the National Medical Products Administration for the clinical trial of HRS-6093 tablets, a novel and selective oral KRAS G12D inhibitor aimed at targeting KRAS G12D mutation proteins for anti-tumor effects [1] Group 1 - The company has announced the approval of a clinical trial for HRS-6093 tablets [1] - HRS-6093 is characterized as a new, efficient, and selective oral KRAS G12D inhibitor [1] - The drug specifically binds to KRAS G12D mutated proteins to exert anti-tumor effects [1]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of four new drugs, indicating a significant advancement in its oncology pipeline [1] Group 1: Drug Approvals - Heng Rui Medicine and its subsidiaries have been granted clinical trial approval for HRS-4508 tablets, SHR-A1811 injection, Adebeli monoclonal antibody injection, and Bevacizumab injection [1] - HRS-4508 is a novel, highly selective tyrosine kinase inhibitor that inhibits tumor cell proliferation to exert anti-tumor effects [1] - SHR-A1811 injection binds to HER2-expressing tumor cells, inducing apoptosis through a unique mechanism involving lysosomal release of toxins [1] Group 2: Immunotherapy Developments - Adebeli monoclonal antibody injection is a humanized anti-PD-L1 monoclonal antibody developed by Heng Rui Medicine, which reactivates the immune system's anti-tumor activity by blocking the PD-1/PD-L1 pathway [1] - Bevacizumab is a humanized anti-VEGF monoclonal antibody, further expanding the company's oncology treatment options [1]

Core Viewpoint - The company, Valiant Biopharma (09887), has seen its stock price increase by over 5%, currently trading at 72.5 HKD, following the completion of patient enrollment in a pivotal clinical study for its drug, Opalizumab (LBL-024), a dual-targeting antibody for treating EP-NEC [1] Group 1 - The pivotal clinical study for Opalizumab (LBL-024), a PD-L1 and 4-1BB dual-targeting antibody, has completed enrollment of all participants [1] - Opalizumab is the first dual-targeting molecule in a pivotal clinical stage aimed at the 4-1BB co-stimulatory receptor, potentially becoming the first approved drug for treating EP-NEC [1] - The 4-1BB agonist can reactivate apoptotic T cells and significantly expand their numbers, making it particularly suitable for treating PD-1/PD-L1 resistant or ineffective cold tumors [1] Group 2 - Besides EP-NEC, Opalizumab has received approval to conduct clinical studies in several cancer types with high unmet clinical needs, including small cell lung cancer (SCLC), biliary tract cancer (BTC), ovarian cancer (OC), non-small cell lung cancer (NSCLC), esophageal squamous cell carcinoma (ESCC), liver cancer (HCC), gastric cancer (GC), triple-negative breast cancer (TNBC), and malignant melanoma [1] - Encouraging clinical results have already been observed in SCLC, BTC, and OC, indicating the potential of Opalizumab as an effective anti-tumor drug with a broad range of indications [1]

Group 1 - The stock of Valiant Pharmaceuticals (09887) has increased by over 5%, currently trading at 72.5 HKD with a transaction volume of 86.43 million HKD [1] - On August 14, the company announced the completion of patient enrollment for the pivotal single-arm clinical study of Opalizumab (LBL-024), a PD-L1/4-1BB bispecific antibody [1] - Opalizumab (LBL-024) is the first bispecific antibody targeting both PD-L1 and 4-1BB, currently in pivotal clinical stages, and is expected to be the first approved drug for treating EP-NEC [1] Group 2 - The 4-1BB agonist can reactivate apoptotic T cells and significantly expand their numbers, making it particularly suitable for treating PD-1/PD-L1 resistant or ineffective cold tumors [2] - Besides EP-NEC, Opalizumab has received approval for clinical studies in several cancers with high unmet clinical needs, including small cell lung cancer (SCLC), biliary tract cancer (BTC), ovarian cancer (OC), non-small cell lung cancer (NSCLC), esophageal squamous cell carcinoma (ESCC), liver cancer (HCC), gastric cancer (GC), triple-negative breast cancer (TNBC), and malignant melanoma [2] - Promising clinical results have been observed in multiple cancer types such as SCLC, BTC, and OC, indicating the potential of Opalizumab as an effective anti-tumor drug with broad indications [2]

Core Viewpoint - 康宁杰瑞制药-B expects to achieve a profit of no less than RMB 20 million for the six months ending June 30, 2025, compared to a loss of approximately RMB 44.9 million in the same period of 2024, indicating a turnaround from loss to profit driven by milestone revenues from three licensing collaborations and sales from commercialized products [1][1][1] Group 1 - Following the announcement, 康宁杰瑞制药-B's stock rose over 3%, currently trading at HKD 9.42 with a transaction volume of HKD 10.1093 million [1][1] - 广发证券 highlights the company's robust proprietary technology platform in ADC, bispecific antibodies, and multifunctional protein engineering, suggesting a strong differentiation in its internal pipeline [1][1] - The company’s pipeline includes various anti-tumor drugs at different stages of development, showcasing its potential for growth in the biopharmaceutical sector [1][1]

Core Viewpoint - The company has received approval from the National Medical Products Administration for its self-developed oral BCL6 PROTAC small molecule drug, HSK47977, aimed at treating non-Hodgkin lymphoma [1] Group 1: Drug Development - HSK47977 targets and degrades the BCL6 protein, inhibiting the occurrence and development of tumor cells [1] - The drug is classified as a Class 1 chemical drug according to the regulations set forth in the announcement on chemical drug registration classification [1] - Preclinical studies have shown that HSK47977 exhibits strong anti-tumor activity, high target selectivity, and an ideal safety window [1] Group 2: Combination Therapy - HSK47977 can achieve a synergistic anti-cancer effect when used in combination with BCL2 inhibitors, indicating its significant development potential [1]