科唯可展示优秀临床数据，解决现有药物临床痛点，具备BIC潜力。根据公告，作为全球新一代抗失眠 药，科唯可已在美国、英国、瑞士等11 个国家及中国香港获批上市，是目前唯一获欧洲药品管理局批 准的改善日间功能的DORA类抗失眠药，安全性良好，无停药反应，未发现成瘾性数据，我们认为有望 填补失眠药物长期安全治疗空白。同时，公司近期与Idorsia公司达成补充协议1，公司将通过现金形式 一次性支付5,000 万美元，并降低科唯可销售里程碑付款和特许权使用费率，我们认为将更有效推进科 唯可的商业化。 公司近况 6 月20 日，公司公告其全球新一代抗失眠药科唯可（盐酸达利雷声片）获国家药监局批准上市，治疗以 入睡困难和/或睡眠维持困难为特征的成人失眠患者，且未被作为精神药品管制。 评论 机构：中金公司 研究员：俞波/陈诗雨/张琎 与NextCure达成战略合作，共同开发SIM0505（CDH6 ADC）。6 月16日，公司公告将SIM0505 除大中 华区以外全球权利授权给NextCure，先声再明在潜在开发阶段将收取最高达7.45 亿美元相关付款以及授 权地区净销售额高至双位数的分级特许权使用费。SIM0505 采用先 ...

Core Viewpoint - CICC has raised the target price of Sihuan Pharmaceutical (02096) by 45.5% to HKD 12.8, reflecting a potential upside of 14.1% based on the company's recent breakthroughs in its innovative pipeline, including the approval of a new insomnia drug and a significant licensing deal for SIM0505 [1][2]. Group 1: Recent Developments - Sihuan Pharmaceutical's new insomnia drug, Kewike (Darelisib), has been approved by the National Medical Products Administration for the treatment of adult insomnia characterized by difficulty in falling asleep and/or maintaining sleep [1]. - Kewike is the only DORA class insomnia drug approved by the European Medicines Agency that improves daytime functioning, with a good safety profile and no withdrawal symptoms reported [1]. - The company has reached a supplementary agreement with Idorsia, involving a one-time cash payment of USD 50 million to expedite the commercialization of Kewike [1]. Group 2: Licensing and Clinical Trials - Sihuan Pharmaceutical has licensed global rights for SIM0505 to NextCure, with potential payments up to USD 745 million and tiered royalties based on net sales in licensed regions [2]. - SIM0505 is currently undergoing Phase I clinical trials in China, with NextCure planning to initiate Phase I trials in the U.S. in Q3 2025 [2]. - The company’s SIM0500 (GPRC5D/BCMA/CD3 tri-antibody) has completed its first patient dosing in the U.S. Phase I trial, and it received Fast Track designation from the FDA in April 2024 [2].

Core Insights - Taiping Medical Health Fund has completed an investment in Hainan Xiansheng Zaiming Pharmaceutical Co., Ltd., a subsidiary of Xiansheng Pharmaceutical Group, which is a leading domestic pharmaceutical company focused on innovative anti-tumor drugs [1] - The investment aims to enhance Xiansheng Zaiming's innovative capabilities and support its participation in international competition and collaboration in tumor immunotherapy [1] - Xiansheng Zaiming has developed several advanced research and development platforms, including protein engineering, T cell engagers, NK cell engagers, ADCs, PROTACs, and AI-assisted molecular design [1] Company Developments - Xiansheng Zaiming has achieved compliance with GMP standards in both China and the United States for its independent production capabilities [1] - The company has four core innovative drugs, namely Kexaila®, Envida®, Endu®, and Enlitai®, which are already commercialized and cover various solid tumor treatments [1] - Kexaila® and Enlitai® are expected to enter the national medical insurance catalog in 2024, following Endu® [1] Strategic Partnerships - Following the investment, Xiansheng Zaiming announced a strategic partnership with Next Cure, Inc. to co-develop a new ADC drug, SIM0505, targeting the CDH6 antigen for solid tumor treatment [3] - The potential development phase of SIM0505 could yield up to $745 million in related payments, including upfront, development, and sales milestone payments, along with tiered royalties based on net sales outside Greater China [3] - Previously, Xiansheng Zaiming entered a licensing option agreement with AbbVie for SIM0500, a tri-specific antibody, with a total value of up to $1.055 billion [6]

此次合作不仅限于SIM0505的全球开发，还包括一项独特的双向技术合作。NextCure获得授权使用先声 再明专有的ADC连接子和TOPOi有效载荷，用于其一款临床前阶段新靶点ADC的开发，而先声再明将 拥有这款新靶点ADC在大中华区的权利。 7.45亿美元背后的中国创新药出海新范式 此次交易金额高达7.45亿美元，是先声药业创新出海战略的又一重要里程碑，也是中国原研创新药通过 BD（业务发展）模式成功走向全球的缩影。 一纸7.45亿美元的合约，将中国原研抗体偶联药物推上全球抗癌新战场。北京时间6月16日，先声药业 旗下抗肿瘤创新药公司先声再明与美国生物制药公司NextCure共同宣布，双方就靶向CDH6的抗体药物 偶联物（ADC）新药SIM0505达成战略合作。 根据协议，NextCure获得SIM0505除大中华区以外的全球开发和商业化权利。先声再明将获得最高达 7.45亿美元的相关付款，包括首付款、开发及销售里程碑款项，并将额外获得基于该产品在大中华区以 外地区净销售额的高至双位数的分级特许权使用费。 CDH6蓝海角逐，中国原研ADC的技术突围 当前全球尚无靶向CDH6的药物上市，该靶点因在卵巢癌、肾癌 ...

值得注意的是，本次合作是先声药业今年达成的第二项海外授权。1月13日，先声再明与艾伯维就自主 研发的三特异性抗体SIM0500（靶向GPRC5D/BCMA/CD3）达成海外权益的许可选择权合作。该药物 通过独特的T细胞衔接器技术激活免疫系统，针对复发难治性多发性骨髓瘤，已在中美同步开展I期临 床，并于2024年获FDA快速通道资格。此项合作潜在交易额达10.55亿美元。 根据协议条款，先声药业有望获得最高达7.45亿美元的款项，其中包括首付款、开发及销售里程碑付 款。此外，先声药业还将享有基于该产品在大中华区以外市场净销售额的分级特许权使用费，比例最高 可达双位数。 据了解，CDH6（钙粘蛋白-6）特异性地定位于上皮细胞的基底外膜，负责介导钙依赖性的细胞间粘 附。CDH6是一个极具潜力的抗肿瘤新药靶点，目前全球尚无靶向CDH6的药物上市，但跨国药企已纷 纷布局。此次先声药业凭借自主研发的CDH6 ADC获得NextCure认可并达成高额授权合作，不仅验证了 其ADC技术平台的创新价值，更标志着公司已具备与国际顶尖药企同台竞技的研发实力。 智通财经APP获悉，6月16日，先声药业（02096）宣布，其附属公司海 ...

2.理想汽车-W (02015) 涨超 7%。 公司一季度营收同比增1.1%，净利润同比增9.4%。预计二季度交付量 同比增13.3%-17.9%，收入同比增2.5%-6.7%。CEO李想表示焕新版车型销量强劲，有信心月销恢复至5 万台水平，并将在7月发布纯电SUV i8。 3.手回集团 (02621) 首挂上市，盘中破发跌超7%。 公司为互联网人身险中介服务商，旗下拥有小雨伞、 咔嚓保、牛保100三大平台，通过在线直营、代理人及合作伙伴分销保险产品。此次上市净筹资约1.34亿 港元 4.宜明昂科-B (01541) 再涨超 13%， 月内股价翻倍。 消息面上，公司于 5 月 22 日公布其核心产品 IMM2510（PD-L1/VEGF 双抗）在中国 I/II 期临床试验中治疗非小细胞肺癌（NSCLC）等实体瘤的初步 有效性和安全性数据（13 例有效性，106 例安全性）。 点击蓝字，关注我们 今日上午港股 1.金山软件 (03888) 盘中跌近 5% ，消息面上，公司一季度收益同比增 9% 至 23.38 亿元，但母公司拥有 人应占溢利同比微降 0.24% 至 2.84 亿元。期内办公软件及服务收益同比增 ...

Core Viewpoint - The recent surge in the Hong Kong innovative drug sector, particularly for Xiansheng Pharmaceutical, is driven by favorable factors such as the cyclical resurgence of COVID-19 and record-breaking domestic innovative drug business development (BD) deals [1] Group 1: Stock Performance - Xiansheng Pharmaceutical's stock price has experienced a continuous rise since May 16, achieving a maximum increase of 28.33% by May 21, with a cumulative increase of nearly 50% year-to-date [1] - The stock has shown significant trading activity, with over 25 million shares traded on three consecutive days from May 19 to 21, indicating strong market interest [4] Group 2: Business Development Potential - The recent $60.5 billion BD deal between Innovent Biologics and Pfizer has spotlighted the potential of Chinese innovative drugs, with Xiansheng Pharmaceutical being a key player in this growth [2] - Xiansheng Pharmaceutical has developed multiple ADC (antibody-drug conjugate) candidates targeting various biomarkers, with products like SCR-A006 showing Best-in-Class potential [2] Group 3: International Expansion - Xiansheng Pharmaceutical has established a track record in international markets, with its first overseas deal for SIM0278 setting a record for domestic autoimmune drug BD at the time [3] - The company has secured a licensing agreement exceeding $1 billion for SIM0500 with AbbVie, currently undergoing clinical trials in the U.S. and China [3] Group 4: Innovation and R&D - The company has invested over 8.5 billion yuan in R&D over six years, developing over 60 innovative drug candidates across various therapeutic areas [5] - Three new drug molecules are in the NDA approval process, while four are in Phase III clinical trials, indicating a robust pipeline [5] - The anticipated launch of significant new drugs will further enhance the company's position in the global biopharmaceutical market [5]