Core Insights - The "Annual Outstanding Biopharmaceutical Enterprises" award recognizes companies with independent core technologies, continuous innovation, and effective transformation of research results into clinical or commercial applications [4] Group 1: Award Announcement - The "Annual Outstanding Biopharmaceutical Enterprises" award will be announced during the "Technology Empowerment, Capital Breakthrough" sharing session held online by Gelonghui on December 22 [1] - Eight companies, including Baillie Gifford (688506.SH), Dongyang Sunshine Pharmaceutical (06887.HK), Dongyao Pharmaceutical-B (01875.HK), and others, have been awarded the title [1] Group 2: Evaluation Criteria - The evaluation for the award is based on a comprehensive assessment of technical innovation, research and development strength, and achievement transformation [4] - The final results were determined through quantitative data analysis and an expert review panel [4] Group 3: Purpose of the Award - Gelonghui aims to create a reference value ranking for listed companies and unicorns in the investment community with the "Golden Gelong Award" [4] - The award covers all listed companies and unicorns on major exchanges, including the Hong Kong Stock Exchange, Shanghai Stock Exchange, Shenzhen Stock Exchange, New York Stock Exchange, and NASDAQ [4]

Core Viewpoint - The agreement between Jiangsu Zaiming and Ipsen Pharma SAS allows Ipsen to obtain global exclusive rights for the development, production, and commercialization of the antibody-drug conjugate SIM0613, targeting LRRC15, outside Greater China, with potential financial benefits for the company totaling up to $1.06 billion [1][1][1] Financial Terms - The agreement includes an upfront payment of $45 million, along with milestone payments related to research, regulatory, and commercialization achievements, and tiered royalties on sales [1][1][1]

Core Viewpoint - The company has entered into an exclusive licensing agreement with Ipsen Pharma SAS for the antibody-drug conjugate SIM0613, targeting LRRC15, which will allow Ipsen to develop, manufacture, and commercialize the drug outside Greater China [1] Group 1 - The agreement grants Ipsen global exclusive rights for the development, production, and commercialization of SIM0613 in regions outside Greater China [1] - The company is entitled to receive up to $1.06 billion in total payments, which includes an upfront payment of $45 million [1] - Additional payments will be based on research, regulatory, and commercialization milestones, along with tiered royalties on sales [1]

Core Viewpoint - The announcement highlights a significant licensing agreement between Jiangsu Xiansheng Zaiming Pharmaceutical Co., Ltd. and Ipsen Pharma SAS, granting Ipsen exclusive global rights to develop, manufacture, and commercialize the antibody-drug conjugate SIM0613 outside Greater China, with potential financial benefits for the company totaling up to $1.06 billion [1]. Group 1: Licensing Agreement Details - Jiangsu Xiansheng has signed an exclusive licensing agreement with Ipsen for the ADC SIM0613, targeting LRRC15 [1]. - Ipsen will pay an upfront fee of $45 million, along with milestone payments related to research, regulatory, and commercialization achievements, and tiered royalties on sales [1]. Group 2: Product Information - SIM0613 is a novel ADC that targets LRRC15, a protein highly expressed on the surface of various solid tumors and cancer-associated fibroblasts, but minimally expressed in normal cells [1]. - The design of SIM0613 allows it to penetrate tumors and cancer-associated fibroblasts effectively, demonstrating significant tumor regression in various preclinical in vivo models [1].

Core Viewpoint - The company announced a licensing agreement with Ipsen Pharma SAS, granting Ipsen exclusive rights to develop, manufacture, and commercialize the antibody-drug conjugate SIM0613 outside Greater China [1] Group 1: Agreement Details - The agreement allows Ipsen to obtain global exclusive rights for SIM0613, which targets LRRC15, developed by Jiangsu Xiansheng [1] - The company is entitled to receive up to $1.06 billion in total payments, which includes an upfront payment of $45 million [1] - Additional payments will be based on research, regulatory, and commercialization milestones, along with tiered royalties on sales [1]

Core Viewpoint - The announcement highlights a significant licensing agreement between Jiangsu Xiansheng Zaiming Pharmaceutical Co., Ltd. and Ipsen Pharma SAS, granting Ipsen exclusive global rights to develop, manufacture, and commercialize the antibody-drug conjugate SIM0613 outside Greater China, with potential financial benefits for the company totaling up to $1.06 billion [1]. Group 1 - Jiangsu Xiansheng has entered into an exclusive licensing agreement with Ipsen Pharma for the ADC SIM0613, targeting LRRC15 [1]. - The agreement includes an upfront payment of $45 million, along with milestone payments related to research, regulatory, and commercialization achievements, and tiered royalties on sales [1]. - SIM0613 is designed to target LRRC15, which is highly expressed in various solid tumors and tumor-associated fibroblasts, while showing minimal expression in normal cells [1]. Group 2 - The ADC SIM0613 is engineered to penetrate tumors and tumor-associated fibroblasts effectively, demonstrating significant tumor regression in various preclinical in vivo models [1]. - The potential total financial inflow of $1.06 billion includes various payment structures, indicating a strong commercial opportunity for Jiangsu Xiansheng [1].

Core Viewpoint - The announcement highlights a significant licensing agreement between Jiangsu Xiansheng and Ipsen Pharma for the ADC SIM0613, indicating a strategic partnership aimed at expanding the drug's market reach outside Greater China [1] Group 1: Licensing Agreement Details - Jiangsu Xiansheng has signed an exclusive licensing agreement with Ipsen Pharma for the global development, production, and commercialization rights of the ADC SIM0613 outside Greater China [1] - The agreement allows Jiangsu Xiansheng to receive up to $1.06 billion, which includes a $45 million upfront payment, milestone payments related to research, regulatory, and commercialization, as well as tiered royalties on sales [1] Group 2: Product Information - SIM0613 is a novel antibody-drug conjugate targeting LRRC15, a protein highly expressed on the surface of various solid tumors and cancer-associated fibroblasts, but minimally expressed in normal cells [1] - The mechanism of SIM0613 involves binding to LRRC15, leading to internalization into tumor cells and the release of cytotoxic payloads, effectively killing tumor cells while sparing normal cells [1] - The design of SIM0613 allows for deep penetration into tumors and cancer-associated fibroblasts, demonstrating significant tumor regression effects in various preclinical in vivo models [1]

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。 SIM0613是一種靶向富含亮氨酸重複序列的蛋白1 5（LRRC15）的新型ADC。 LRRC15在多種實體瘤和腫瘤相關成纖維細胞（CAF）表面高表達，但正常細胞中 極少表達。SIM0613與LRRC15結合後通過內吞進入腫瘤細胞後，釋放細胞毒性有 效載荷，從而殺死腫瘤細胞，同時較少影響正常細胞。SIM0613經過特殊設計， 能夠深入滲透腫瘤和腫瘤相關成纖維細胞，在多種臨床前體內模型中均顯示展現 出顯著的腫瘤消退效果。 Simcere Pharmaceutical Group Limited 先聲藥業集團有限公司 （於香港註冊成立的有限公司） （股份代號：2096） 自願公告 與Ipsen就SIM0613（LRRC15抗體偶聯藥物） 簽訂獨家授權許可協議 本公告由先聲藥業集團有限公司（「本公司」，連同其附屬公司統稱「本集團」）自 願作出，以告知本公司股東及潛在投資者本集團最新業務更新。 本公司董事（「董 ...

Investment Rating - The report does not explicitly state an investment rating for the industry or specific companies involved in the development of oral SERDs for breast cancer treatment. Core Insights - The report highlights the recent FDA approval of Imlunestrant, an oral SERD developed by Eli Lilly, for the treatment of ER+/HER2–/ESR1 mutant advanced or metastatic breast cancer, marking it as the second oral SERD approved after Elacestrant [18][19] - The EMBER-3 trial results indicate that Imlunestrant significantly improves progression-free survival (PFS) compared to standard endocrine therapy, with a median PFS of 5.5 months versus 3.8 months for standard therapy [23] - Giredestrant, developed by Roche, has shown positive results in the III phase evERA trial, demonstrating significant benefits in PFS compared to standard treatment in patients previously treated with CDK4/6 inhibitors [27] - Camizestrant, another oral SERD from AstraZeneca, has shown promising efficacy in the SERENA-6 trial, with a median PFS of 16.6 months when combined with CDK4/6 inhibitors [33] Summary by Sections Section 1: Focus on Innovative Drugs - The report reviews the advancements in innovative drugs, particularly in the field of breast cancer treatment, emphasizing the importance of oral SERDs [2][5] Section 2: Current Status of ER+ Breast Cancer Therapies - The report discusses the current landscape of therapies for ER+ breast cancer, including the mechanisms of action for various anti-estrogen therapies and the challenges of resistance faced by patients [10][8] Section 3: Clinical Development of New Oral SERDs - The report details the clinical development progress of several new oral SERDs, including Imlunestrant, Giredestrant, and Camizestrant, highlighting their respective phases and trial outcomes [12][11][33] Section 4: Market Dynamics and Company Performance - The report provides insights into the market dynamics of the biotech sector, including stock performance of key companies involved in the development of innovative cancer therapies [46][49]

Group 1 - The autoimmune disease market is a blue ocean, with new targets and mechanisms driving rapid industry development. The global autoimmune market reached $132.3 billion in 2022 and is expected to grow to $176.7 billion by 2030, with a CAGR of 3.68% [2][3] - The drug development paradigm is shifting from broad-spectrum anti-inflammatory treatments to precision regulation, with significant room for improvement in efficacy and safety of existing drugs [2][3] Group 2 - Psoriasis affects approximately 125 million patients globally, with a focus on large molecule antibody drugs and a surge in small molecule oral TYK2 inhibitors that may replace existing treatments [3] - Atopic dermatitis impacts over 204 million people worldwide, with Dupilumab achieving sales exceeding $12.9 billion in the first three quarters of 2025, and new oral drugs like STAT6PROTAC showing superior efficacy [3] - The clinical demand for autoimmune diseases remains largely unmet, with domestic companies actively innovating in drug development, focusing on target innovation and expanding indications [4] Group 3 - Companies to watch include: 1. **Xiansheng Pharmaceutical**: Focused on differentiated targets with potential candidates like SIM0278, SIM0709, and SIM0711 [4] 2. **Kangnuo Pharmaceutical**: Rapidly increasing sales of Dupilumab, with peak sales expected to reach 5 billion yuan; CM512 shows promise as a leading TSLPxIL-13 dual antibody [4] 3. **Quansheng Biotechnology**: QX013N targets c-kit for CSU treatment, with additional dual antibody projects expected to submit IND applications between 2025 and 2026 [4] 4. **Yifang Biotechnology**: D-2570 (TYK2 inhibitor) is in Phase II clinical trials for UC, with promising Phase II data for psoriasis [4] 5. **Sanofi Genzyme**: Rapidly advancing IL-5 monoclonal antibody for asthma, with NDA submission expected by 2027 [4]