Core Viewpoint - Shionogi plans to acquire the ALS drug business from Taro Pharmaceutical, which includes the oral suspension Radicava ORS and its intravenous formulation, aiming to enhance its rare disease commercialization platform in the U.S. market [1][3][10] Group 1: Acquisition Details - The transaction is expected to close on or after April 1, 2026, and will add approximately $700 million in global sales annually for Shionogi [3][10] - Shionogi will pay a one-time fee of $2.5 billion for the Radicava-related business, with potential future royalties contingent on specific conditions [3][10] - Post-acquisition, the Radicava business unit will operate as a wholly-owned subsidiary of Shionogi [3][10] Group 2: Strategic Importance - The acquisition will support Shionogi's plans to launch drugs for Fragile X syndrome, Jordan's syndrome, and Pompe disease [3][10] - Radicava's intravenous formulation was approved by the FDA in 2017, marking it as the first new ALS treatment in decades, and the oral formulation was approved five years later, providing a more convenient treatment option for patients [3][10] Group 3: Industry Context - Shionogi has been active in the M&A market, recently acquiring early-stage rare disease assets from Japan Tobacco and collaborating with Swiss biotech company BioVersys for a preclinical antibiotic project [3][10] - On the same day, Ipsen and Ascendia announced an exclusive licensing agreement for ADC SIM0613, highlighting the ongoing consolidation in the global pharmaceutical industry [3][12][14]

Core Viewpoint - The company, Sihuan Pharmaceutical (02096.HK), has received approval from the National Medical Products Administration of China for clinical trials of its self-developed bispecific antibody-drug conjugate candidate SIM0610, aimed at treating patients with locally advanced or metastatic solid tumors [1] Group 1 - The candidate drug SIM0610 is a bispecific antibody-drug conjugate (BsADC) [1] - The clinical trials will focus on patients with locally advanced or metastatic solid tumors [1]

Core Viewpoint - The company, Sihon Pharmaceutical, has received approval from the National Medical Products Administration of China for clinical trials of its dual-specific antibody-drug conjugate candidate SIM0610, aimed at treating patients with locally advanced or metastatic solid tumors [1] Group 1: Product Development - SIM0610 targets both Epidermal Growth Factor Receptor (EGFR) and c-MET, utilizing a dual-target approach to enhance anti-tumor activity and potentially overcome resistance associated with EGFR-Tyrosine Kinase Inhibitors (EGFR-TKIs) [1] - Preclinical studies have demonstrated significant anti-tumor activity of SIM0610 across various tumor models [1] Group 2: Company Profile - The company is an innovation and research-driven pharmaceutical firm, operating a national key laboratory for neuro and oncology drug development [1] - The company focuses on neuroscience, oncology, autoimmune diseases, and anti-infective fields, while strategically positioning itself in areas with significant clinical needs [1] - The company emphasizes a mission of "born for patients" and drives its initiatives through independent research and collaborative innovation, establishing strategic partnerships with various innovative enterprises and research institutions [1]

Core Viewpoint - The company announced that its self-developed bispecific antibody-drug conjugate (BsADC) candidate SIM0610 has received clinical trial approval from the National Medical Products Administration of China for trials targeting patients with locally advanced or metastatic solid tumors [1] Group 1: Product Development - SIM0610 targets both epidermal growth factor receptor (EGFR) and mesenchymal epithelial transition factor (cMET), releasing topoisomerase I inhibitors (TOP1i) to induce apoptosis in tumor cells [1] - The activation of EGFR and cMET is abnormally high in various solid tumors, including non-small cell lung cancer, with cMET activation being a significant mechanism for resistance to epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) [1] - Preclinical studies have shown that SIM0610 exhibits significant anti-tumor activity across various tumor models [1] Group 2: Company Overview - The company is an innovation and research-driven pharmaceutical firm, operating a "National Key Laboratory for Neuroscience and Oncology Drug Development" [1] - The company focuses on neuroscience, anti-tumor, autoimmune, and anti-infection fields, while proactively positioning itself in areas with significant clinical needs [1] - The company emphasizes its mission of "born for patients" through self-innovation and collaborative innovation, establishing strategic partnerships with various innovative enterprises and research institutions [1]

Core Viewpoint - The announcement highlights that the bi-specific antibody-drug conjugate candidate SIM0610 developed by the company has received clinical trial approval from the National Medical Products Administration of China for trials targeting patients with locally advanced or metastatic solid tumors [1] Group 1: Drug Development - SIM0610 targets both epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition factor (cMET) as a bi-specific antibody-drug conjugate (BsADC) [1] - The drug induces apoptosis in tumor cells by releasing topoisomerase I inhibitors (TOP1i) through internalization [1] - Preclinical studies have shown significant anti-tumor activity of SIM0610 across various tumor models [1] Group 2: Mechanism of Action - EGFR and cMET are abnormally activated in several solid tumors, including non-small cell lung cancer [1] - Activation of cMET is a key mechanism for resistance to epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) [1] - The dual-target approach of SIM0610 is expected to enhance anti-tumor activity and overcome drug resistance [1]

本公司董事（「董事」）會（「董事會」）欣然宣佈，本集團自主研發的雙特異性抗體 偶聯藥物（「BsADC」）候選新藥SIM0610已獲得中國國家藥品監督管理局簽發的藥 物臨床試驗批准通知書，擬開展針對局部晚期╱轉移性實體瘤患者的臨床試驗。 關於SIM0610 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。 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 SIM0610（EGFR/cMET雙特異性抗體偶聯藥物） 獲國家藥品監督管理局簽發藥物臨床試驗批准通知書 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。 董事長兼首席執行官 任晉生先生 香港，2025年12月23日 於本公告日期，董事會包括董事長兼執行董事任晉生先生、執行董事唐任宏先 生、萬玉山先生及王熙女士； ...

Investment Rating - The investment rating for the company is maintained at "Buy" with a target price of HKD 19.82 [1][5][11] Core Insights - The company has successfully licensed its SIM0613 (LRRC15 ADC) to France's Ipsen for an upfront payment of USD 45 million and a total deal value of USD 1.06 billion, marking the third licensing deal in 2025 and indicating the company's innovative drug pipeline is entering a monetization phase [1][2] - The SIM0613 ADC platform shows significant potential, with advantages demonstrated in preclinical models and no direct competitors in clinical stages, positioning it as a potential first-in-class (FIC) product globally [2][3] - The company is accelerating its global pipeline expansion, with multiple products and technology platforms poised for overseas exploration, including promising candidates in autoimmune and oncology fields [3][4] Financial Projections - The adjusted net profit forecasts for 2025, 2026, and 2027 are projected at RMB 1.18 billion, RMB 1.40 billion, and RMB 1.52 billion respectively, reflecting a compound annual growth rate (CAGR) of 14% from 2025 to 2027 [5][11] - The expected earnings per share (EPS) for the same years are RMB 0.45, RMB 0.54, and RMB 0.59, with a price-to-earnings (PE) ratio projected to be 33.19x for 2026 [5][11][12]

新华财经南京12月22日电（记者朱程）22日，先声再明宣布已与法国益普生公司就一款抗体偶联药物 （ADC）SIM0613达成大中华区以外全球权益的独家许可协议，先声再明可获得高达10.6亿美元的交易 总付款，还可获得分级特许权使用费。 SIM0613经过特殊设计，能够深入渗透肿瘤和肿瘤相关成纤维细胞，在多种临床前研究中均展现出显著 的抗肿瘤活性。"我们很高兴与法国益普生就该候选创新药达成合作，期待双方携手高效率推进 SIM0613的临床开发。"先声再明首席执行官唐任宏说。 据悉，这是先声再明在2025年度达成对外许可的第三个早研项目。截至2025年12月22日，先声再明母公 司先声药业集团已有四个自研创新药专利技术实现对外授权，累计授权交易金额近34亿美元。 （文章来源：新华财经） ...

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 was announced during the "Technology Empowerment, Capital Breakthrough" sharing session held online by Gelonghui on December 22 [1] - Eight companies were awarded, including Baillie Tianheng (688506.SH), Dongyang Sunshine Pharmaceutical (06887.HK), Dongyao Pharmaceutical-B (01875.HK), and others, listed in alphabetical order [1] Group 2: Evaluation Criteria - The evaluation for the award was based on a comprehensive assessment of technical innovation, research and development strength, and achievement transformation [4] - The final results were derived through quantitative data analysis and expert review [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 - On December 22, the company announced a licensing agreement with Ipsen for the global development, production, and commercialization rights of the antibody-drug conjugate SIM0613, targeting LRRC15, outside Greater China, with potential payments up to $1.06 billion [1] Group 1: Agreement Details - The agreement includes an upfront payment of $45 million, along with milestone payments related to research, regulatory, and commercialization phases [1] - The company is entitled to receive tiered royalties on sales of SIM0613 [1] Group 2: Product Information - SIM0613 is a novel ADC that targets LRRC15, which is highly expressed on the surface of various solid tumors and cancer-associated fibroblasts (CAFs), but minimally expressed in normal cells [1] - Upon binding to LRRC15, SIM0613 enters tumor cells through endocytosis, releasing a cytotoxic payload that kills tumor cells while sparing normal cells [1] - The design of SIM0613 allows for deep penetration into tumors and CAFs, demonstrating significant tumor regression effects in various preclinical in vivo models [1]