SINO BIOPHARM(01177)
Search documents
港股异动 | 中国生物制药(01177)涨超3% 维特柯妥拜单抗“CLDN18.2 ADC”III期临床试验完成受试者入组
智通财经网· 2026-02-09 03:00
智通财经APP获悉,中国生物制药(01177)涨超3%,截至发稿,涨3.09%,报6.68港元,成交额1.49亿港 元。 消息面上,2月9日,中国生物制药发布公告,集团全资附属公司礼新医药科技(上海)有限公司(礼新医 药)自主研发的国家1类创新药维特柯妥拜单抗(研发代号:LM-302)"CLDN18.2 ADC"正在开展用于治疗 三线及以上CLDN18.2阳性的局部晚期或转移性胃及胃食管交界部腺癌的III期注册临床试验(LM302-03- 101),已顺利完成患者入组。其中,LM302是全球首款完成注册III期临床试验入组的CLDN18.2 ADC药 物。 在2025年美国临床肿瘤学会(ASCO)年会上,礼新医药公布了LM-302联合特瑞普利单抗治疗胃癌的最新 研究数据:在41例疗效可评估的患者中,客观缓解率(ORR)为65.9%,疾病控制率(DCR)为 85.4%。其 中,在CLDN18.2表达≥25%的32例患者中,ORR达到71.9%,DCR达到96.9%。按PD-L1 表达分层分 析,PD-L1 CPS<1的患者ORR为63.3%,CPS≥1的患者ORR为77.8%。该研究表明,LM302联合治疗方案 ...
中国生物制药:维特柯妥拜单抗“CLDN18.2 ADC”III期临床试验完成受试者入组
Zhi Tong Cai Jing· 2026-02-08 22:25
Core Viewpoint - China Biologic Products (01177) announced that its wholly-owned subsidiary, Lixin Pharmaceutical Technology (Shanghai) Co., Ltd., has initiated a Phase III registration clinical trial for its self-developed innovative drug, LM-302, targeting CLDN18.2-positive advanced gastric and gastroesophageal junction adenocarcinoma [1][2]. Group 1: Clinical Development - LM-302 is the first CLDN18.2 antibody-drug conjugate (ADC) to complete patient enrollment in a Phase III clinical trial globally [1]. - The drug specifically targets CLDN18.2-positive tumor cells, delivering a small molecule toxin to achieve precise tumor cell destruction [1]. - The ongoing Phase III trial focuses on patients with locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma who have received three or more prior lines of therapy [2]. Group 2: Clinical Results - At the 2025 American Society of Clinical Oncology (ASCO) annual meeting, Lixin Pharmaceutical reported that in 41 evaluable patients, the objective response rate (ORR) was 65.9% and the disease control rate (DCR) was 85.4% [2]. - Among 32 patients with CLDN18.2 expression ≥25%, the ORR reached 71.9% and the DCR was 96.9% [2]. - The study also indicated that for patients with PD-L1 CPS <1, the ORR was 63.3%, while for those with CPS ≥1, the ORR was 77.8% [2]. Group 3: Future Plans and Regulatory Status - In addition to the ongoing Phase III study, LM-302 is set to undergo another Phase III registration trial in China, focusing on first-line treatment for CLDN18.2-positive locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma [2]. - LM-302 has been included in the breakthrough therapy designation by the China National Medical Products Administration (NMPA) and has received orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) [2]. Group 4: Company Strategy - Leveraging strong resources and industrial capabilities, Lixin Pharmaceutical is accelerating the clinical translation and commercialization of more innovative drugs, aiming to provide accessible treatment options for global cancer patients [3].
中国生物制药(01177):维特柯妥拜单抗“CLDN18.2 ADC”III期临床试验完成受试者入组
智通财经网· 2026-02-08 22:23
智通财经APP讯,中国生物制药(01177)发布公告,集团全资附属公司礼新医药科技(上海)有限公司(礼新 医药)自主研发的国家1类创新药维特柯妥拜单抗(研发代号:LM-302)"CLDN18.2 ADC"正在开展用于治 疗三线及以上CLDN18.2阳性的局部晚期或转移性胃及胃食管交界部腺癌的III期注册临床试验(LM302- 03-101),已顺利完成患者入组。其中,LM302是全球首款完成注册III期临床试验入组的CLDN18.2 ADC 药物。 LM-302是一款靶向CLDN18.2的抗体偶联药物(ADC),通过与CLDN18.2阳性肿瘤细胞特异性结合,并 经内吞作用进入细胞后释放小分子毒素,从而实现对肿瘤细胞的精准杀伤。作为潜在同类首创 (FIC)药 物,LM-302在胃癌、胰腺癌及胆道癌等多个消化道肿瘤中展现出良好的临床开发潜力,并有望为 CLDN18.2低表达和PD-L1低表达患者提供新的治疗选择。 在2025年美国临床肿瘤学会(ASCO)年会上,礼新医药公布了LM-302联合特瑞普利单抗治疗胃癌的最新 研究数据:在41例疗效可评估的患者中,客观缓解率(ORR)为65.9%,疾病控制率(DCR)为 ...
中国生物制药(01177) - 自愿公告 - 维特柯妥拜单抗「CLDN18.2 ADC」III期临床...
2026-02-08 22:10
中國生物製藥有限公司(「本公司」,連同其附屬公司統稱「本集團」)董事會(「董事會」)宣佈,本集團全 資附屬公司禮新醫藥科技(上海)有限公司(「禮新醫藥」)自主研發的國家1類創新藥維特柯妥拜單抗(研 發代號:LM-302)「CLDN18.2 ADC」正在開展用於治療三線及以上CLDN18.2陽性的局部晚期或轉移 性胃及胃食管交界部腺癌的III期註冊臨床試驗(LM302-03-101),已順利完成患者入組。其中,LM- 302是全球首款完成註冊III期臨床試驗入組的CLDN18.2 ADC藥物。 LM-302是一款靶向CLDN18.2的抗體偶聯藥物(ADC),通過與CLDN18.2陽性腫瘤細胞特異性結合, 並經內吞作用進入細胞後釋放小分子毒素,從而實現對腫瘤細胞的精準殺傷。作為潛在同類首創 (FIC)藥物,LM-302在胃癌、胰腺癌及膽道癌等多個消化道腫瘤中展現出良好的臨床開發潛力,並有 望為CLDN18.2低表達和PD-L1低表達患者提供新的治療選擇。 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份內容而產生 ...
——海外消费周报(20260130-20260205):港股医药 2025 年报业绩前瞻:商业化销售放量叠加授权收入,部分公司有望迎来盈利拐点-20260208
Shenwan Hongyuan Securities· 2026-02-08 13:37
海外消费服务 2026年02月08日 版 发行业 相关研究 #研究 证券分析师 黄哲 A0230513030001 huangzhe@swsresearch.com 周文远 A0230518110003 zhouwy@swsresearch.com 贾梦迪 A0230520010002 jiamd@swsresearch.com 册 分歧了后 胡梦婷 A0230524060004 humt@swsresearch.com 联系人 胡梦婷 A0230524060004 humt@swsresearch.com 申万宏源研究微信服务号 港股医药 2025 年报业绩前瞻: 商业化销售放量叠加 授权收入,部分公司有望迎来盈利拐点 -海外消费周报(20260130-20260205) 海外医药:港股医药 2025 年报业绩前瞻——商业化销售放量叠加授权收入,部分公司 ● 有望迎来盈利拐点 创新药:商业化销售放量叠加授权收入,部分公司有望迎来盈利拐点。创新药板块,我 们预计 2025 年有望实现盈利的公司包括:百济神州、信达生物、荣昌生物、复宏汉 霖、诺诚健华,以及和黄医药等,主要由于核心产品的商业化销售放量以及 BD ...
海外消费周报:港股医药2025年报业绩前瞻:商业化销售放量叠加授权收入,部分公司有望迎来盈利拐点-20260208
Shenwan Hongyuan Securities· 2026-02-08 09:41
行 业 及 产 业 海外消费服务 行 业 研 究 / 行 业 点 评 相关研究 证 券 研 究 报 告 证券分析师 黄哲 A0230513030001 huangzhe@swsresearch.com 周文远 A0230518110003 zhouwy@swsresearch.com 贾梦迪 A0230520010002 jiamd@swsresearch.com 研究支持 胡梦婷 A0230524060004 humt@swsresearch.com 联系人 胡梦婷 A0230524060004 2026 年 02 月 08 日 港股医药 2025 年报业绩前瞻:商业化销售放量叠加 授权收入,部分公司有望迎来盈利拐点 看好 ——海外消费周报(20260130-20260205) 本期投资提示: ⚫ 海外医药:港股医药 2025 年报业绩前瞻——商业化销售放量叠加授权收入,部分公司 有望迎来盈利拐点 创新药:商业化销售放量叠加授权收入,部分公司有望迎来盈利拐点。创新药板块,我 们预计 2025 年有望实现盈利的公司包括:百济神州、信达生物、荣昌生物、复宏汉 霖、诺诚健华,以及和黄医药等,主要由于核心产品的商业 ...
港股创新药ETF(159567)涨0.79%,成交额8.49亿元
Xin Lang Cai Jing· 2026-02-06 12:25
来源:新浪基金∞工作室 最新定期报告显示,港股创新药ETF(159567)重仓股包括石药集团、百济神州、康方生物、中国生物 制药、中国生物制药、信达生物、三生制药、翰森制药、科伦博泰生物-B、康哲药业,持仓占比如下。 股票代码股票名称持仓占比持仓股数(股)持仓市值(元)01093石药集团10.44%1.08亿8.25亿06160百 济神州9.91%482.99万7.82亿09926康方生物9.72%752.00万7.68亿01177中国生物制药9.66%1.37亿7.63亿 08027中国生物制药9.66%1.37亿7.63亿01801信达生物9.53%1092.95万7.53亿01530三生制药6.95%2512.55 万5.49亿03692翰森制药6.93%1679.60万5.47亿06990科伦博泰生物-B3.48%77.48万2.74亿00867康哲药业 2.55%1729.70万2.02亿 声明:市场有风险,投资需谨慎。本文基于第三方数据库自动发布,不代表新浪财经观点,任何在本文 出现的信息均只作为参考,不构成个人投资建议。如有出入请以实际公告为准。如有疑问,请联系 biz@staff.sina.c ...
美国医药调研反馈:肿瘤、代谢、自免、中枢神经系统赛道推荐更新
Haitong Securities International· 2026-02-06 11:33
Investment Rating - The report provides an "Outperform" rating for multiple companies in the healthcare sector, including BeiGene, JD Health, WuXi Biologics, and others, indicating a positive outlook for these stocks [1]. Core Insights - The macro and industry environment is improving due to the resolution of policy uncertainties, the release of significant clinical data, and a resurgence in global M&A activity, leading to a notable increase in investor sentiment towards innovative drugs for 2026 [4][11]. - In oncology, the PD-1/VEGF dual antibody approach is transitioning from "mechanism validation" to "clinical and industrial resonance," with multiple global Phase III trials underway, expected to catalyze approvals and data releases within the year [5][17]. - The metabolic sector is seeing growth in the cash-pay market for GLP-1 drugs, driven by limited insurance coverage and high out-of-pocket costs, prompting companies to enhance accessibility through direct sales and pricing adjustments [6][25]. - In the autoimmune space, there is a growing concentration risk among major products from multinational corporations (MNCs), with new antibody platforms expected to yield significant data in 2026, potentially leading to new business development opportunities [7]. - The central nervous system (CNS) investment focus remains on advancing Aβ monoclonal antibody treatments, with key data expected to open up early intervention market opportunities [9]. Summary by Sections Oncology - The PD-1/VEGF dual antibody's clinical and industrial certainty is strengthening, with major companies conducting multiple global Phase III trials across high-value indications [17]. - The Pan-RAS precision therapy is entering a realization phase, with key Phase III data expected in 2026 for pancreatic cancer and NSCLC [22]. Metabolic - The cash-pay market for GLP-1 drugs is expanding due to limited insurance coverage, with companies like Eli Lilly and Novo Nordisk adopting different direct-to-consumer strategies to enhance accessibility [25][26]. - Small nucleic acid therapies are expected to upgrade treatment paradigms, showing competitive data in weight loss and safety profiles when combined with GLP-1 [30]. Autoimmune - MNCs are increasingly reliant on a few blockbuster products, with structural opportunities arising from new antibody platforms expected to report data in 2026 [7]. - The trend towards oral formulations in autoimmune diseases is gaining traction, offering advantages in adherence and competitive differentiation [7]. CNS - The focus in CNS remains on Aβ monoclonal antibody treatments, with advancements expected to shift treatment towards earlier intervention populations [9]. - New delivery methods, such as systemic administration of small nucleic acids, are being explored as complementary approaches [9].
国产创新药,正在破局
3 6 Ke· 2026-02-05 11:26
Core Viewpoint - The article discusses the significant progress in China's innovative drug development, highlighting the increase in the number of new drugs approved and the growing competitiveness of Chinese pharmaceutical companies in both domestic and international markets [4][16]. Group 1: Growth of Innovative Drugs - In 2024, the number of domestically developed Class 1 new drugs in China reached 40, a substantial increase from just 9 in 2018 [2][3][4]. - Since the beginning of the 14th Five-Year Plan, 113 innovative drugs have been approved, which is 2.8 times the number approved during the 13th Five-Year Plan [4]. - As of August 2024, there are 910 new drugs available in China, indicating a robust growth in the pharmaceutical market [6]. Group 2: Clinical Trials and Breakthroughs - In a head-to-head clinical trial, the drug Ivoris (依沃西单抗) developed by Kangfang Biopharma outperformed the global best-selling cancer drug, Pembrolizumab (K drug), marking a significant achievement for Chinese innovation [7][9]. - The global sales of Pembrolizumab reached $29.482 billion in 2024, underscoring the competitive landscape [8]. Group 3: Market Dynamics and International Expansion - Chinese innovative drugs are not only performing well domestically but are also gaining traction in international markets, with products like Sidakio (西达基奥仑赛) achieving $1.596 billion in cumulative sales since its launch [12][13]. - The total transaction scale of technology licensing by Chinese pharmaceutical companies exceeded $34 billion in 2024, indicating a shift towards international collaboration [14][15]. Group 4: R&D Landscape and Challenges - As of August 2024, there are 5,380 new drug candidates in development in China, accounting for over one-third of the global pipeline [18]. - The average cost of developing an innovative drug is around $1 billion, with a typical development timeline of 10 years [20][21]. - The efficiency of drug development in China is improving, with preclinical phases taking 12-20 months compared to 24-36 months internationally [23]. Group 5: Policy Support and Ecosystem - The Chinese government has implemented various policies since 2008 to support innovative drug development, including expedited approval processes and financial incentives [28][29]. - The combination of government support, industry collaboration, and technological advancements is creating a conducive environment for innovation in the pharmaceutical sector [41]. Group 6: Future Outlook - The article emphasizes that the development of innovative drugs in China has made significant strides over the past decade, transitioning from imitation to innovation [42]. - The government's continued support for innovative drugs is expected to enhance the industry's growth and provide hope for patients [42].
智通港股沽空统计|2月5日
智通财经网· 2026-02-05 00:24
| 股票名称 | 沽空金额 | 沽空比率↓ | 偏离值 | | --- | --- | --- | --- | | 京东集团-SWR(89618) | 139.10 万元 | 85.52% | 19.58% | | 友邦保险-R(81299) | 59.19 万元 | 77.11% | 7.06% | | 联想集团-R(80992) | 236.30 万元 | 67.79% | -13.42% | | 快手-WR(81024) | 110.64 万元 | 63.84% | 11.07% | | 小米集团-WR(81810) | 127.60 万元 | 60.41% | 13.73% | | 中银香港-R(82388) | 5.50 万元 | 59.99% | 17.57% | | 华泰证券(06886) | 3.74 亿元 | 56.96% | 40.23% | | 创科实业(00669) | 6.62 亿元 | 54.74% | 26.43% | | 贝壳-W(02423) | 4.65 亿元 | 53.19% | 19.47% | | 百度集团-SWR(89888) | 169.98 万元 | 52.00 ...