Core Viewpoint - Bailitianheng's stock price has shown significant growth since its IPO, with analysts optimistic about its future potential and clinical developments [2][3][4]. Stock Performance - As of April 23, Bailitianheng's stock closed at 283.50 CNY, with a market capitalization exceeding 100 billion CNY [2]. - On April 22, the stock reached a new high of 291.51 CNY, marking an increase of 11.41% for the day and a total increase of approximately 1080.20% since its IPO at 24.7 CNY per share on January 6, 2023 [3]. - The stock has outperformed peers such as Heng Rui Medicine and BeiGene, with a year-to-date increase of about 19.47% [3]. Analyst Ratings - Pacific Securities has issued a "Buy" rating for Bailitianheng, projecting a target price of 333.52 CNY, indicating a potential upside of 14.41% from the current price [4]. Clinical Pipeline - The core pipeline product, BL-B01D1, is expected to be submitted for domestic approval this year and is set to initiate its first overseas Phase III clinical trial in the first half of the year [5]. - BL-B01D1 is involved in nine Phase III clinical trials in China and aims to address multiple indications, including nasopharyngeal carcinoma and esophageal squamous cell carcinoma, with NDA submissions anticipated in Q2 [5][6]. Competitive Landscape - BL-B01D1 is one of the few drugs targeting the EGFRxHER3 pathway, with only Bailitianheng and Innovent Biologics actively developing such therapies [6][7]. - The company is also advancing another product, BL-M07D1, which is undergoing 11 clinical trials across various stages and indications, including HER2-positive cancers [6][7]. Future Developments - The company is expected to submit applications for additional indications of BL-B01D1 by 2026, including non-small cell lung cancer and breast cancer [6]. - BL-M11D1, another ADC in development, has received approval for clinical trials in combination therapies for acute myeloid leukemia, with the potential to address safety issues seen in similar drugs [7].

Group 1 - The company has received formal approval from the National Medical Products Administration (NMPA) for the clinical trial of its innovative biological drug, BL-M11D1, for the treatment of newly diagnosed acute myeloid leukemia (AML) [1] - The clinical trial will evaluate the drug in combination with either cytarabine and daunorubicin or venetoclax and azacitidine [1] - BL-M11D1 is a targeted antibody-drug conjugate (ADC) that shares the same technology platform as another drug, BL-B01D1, and is currently undergoing Phase I clinical trials in the U.S. for relapsed or refractory AML [1]

｜ 2025年4月23日星期三｜ NO.1百利天恒BL-M11D1联合治疗新诊断的急性髓系白血病获批临床 百利天恒近日收到国家药品监督管理局正式批准签发的《药物临床试验批准通知书》，公司自主研发的 创新生物药注射用BL-M11D1(CD33-ADC)联合用药的药物临床试验获得批准。BL-M11D1将开展联合阿 糖胞苷+柔红霉素或维奈克拉+阿扎胞苷治疗新诊断的急性髓系白血病的临床试验。 点评：BL-M11D1联合疗法获临床批件，标志着国内创新ADC药物在血液肿瘤领域取得重要进展。联合 传统化疗(阿糖胞苷+柔红霉素)或靶向组合(维奈克拉+阿扎胞苷)的双路径探索，既体现了对现有治疗体 系的补充优化，也展现了差异化开发策略。 NO.4阿斯利康瑞利珠单抗国内获批上市 阿斯利康宣布瑞利珠单抗在国内获批上市，与常规治疗药物联合用于治疗抗乙酰胆碱受体(AChR)抗体 阳性的成人全身型重症肌无力(gMG)患者。瑞利珠单抗是阿斯利康重金收购Alexion后获得的重要罕见病 管线，这是一款长效C5补体抑制剂。 点评：该药物于2024年度全球销售额已经达到39.24亿美元，成为阿斯利康罕见病部门中的销冠药物。 2024年10月阿斯利 ...

中欧基金投资总监葛兰在管规模最大基金——中欧医疗健康的股票仓位升至历史最高水平。 4月22日，中欧基金投资总监葛兰在管基金披露了2025年一季报。股票仓位方面，中欧医疗健康的股票 仓位升至历史最高水平，达94.24%；中欧医疗创新的股票仓位升至历史次高，为92.68%。 在调仓换股上，葛兰减持了药明康德、恒瑞医药、凯莱英；增持科伦药业、芯原股份、科伦博泰生物、 药明生物、康方生物。 从业绩表现上来看，在2025年一季度期间，中欧医疗健康、中欧医疗创新大幅跑赢同期业绩比较基准， 但3只基金仍持续遭遇净赎回。 展望二季度，葛兰仍旧看好创新药持续突破、消费医疗复苏与产业链关键环节国产化等方向。 科伦药业新进中欧医疗健康持仓前十 目前，葛兰在管3只公募基金，分别是中欧医疗健康、中欧医疗创新、中欧明睿新起点混合。其中规模 最大的产品是中欧医疗健康。 从基金业绩情况来看，截至2025年一季度末，中欧医疗健康A、C类份额净值增长率分别为2.37%、 2.17%，同期业绩比较基准收益率为0.46%。 尽管跑赢同期业绩比较基准，但该基金在2025年一季度末的规模依旧较2024年末时小幅度下降，为 311.79亿元。此外，中欧医 ...

证券代码：688506 证券简称：百利天恒 公告编号：2025-034 四川百利天恒药业股份有限公司 自愿披露关于 BL-M11D1（CD33-ADC）联合用药治疗新诊断 的急性髓系白血病获得药物临床试验批准通知书的公告 申请事项：境内生产药品注册临床试验 申请人：成都百利多特生物药业有限责任公司；四川百利药业有限责任公司 结论：根据《中华人民共和国药品管理法》及有关规定，经审查，注射用 BL-M11D1 临床试验申请符合药品注册的有关要求，同意本品开展联合阿糖胞苷+ 柔红霉素或维奈克拉+阿扎胞苷治疗新诊断的急性髓系白血病的临床试验。 二、药品的其他情况 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或 者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 四川百利天恒药业股份有限公司（以下简称"公司"）近日收到国家药品监督 管理局(NMPA)正式批准签发的《药物临床试验批准通知书》，公司自主研发的创新 生物药注射用 BL-M11D1（CD33-ADC）联合用药的药物临床试验获得批准。现将 相关情况公告如下： 一、《药物临床试验批准通知书》基本情况 产品名称：注射用 BL-M1 ...

百利天恒公告，公司自主研发的创新生物药注射用BL-M11D1(CD33-ADC)联合用药的药物临床试验获 得国家药品监督管理局批准。目前，BL-M11D1正在国内进行Ib期临床试验，并在美国同步进行I期临床 试验，适应症为复发或难治性急性髓系白血病(r/rAML)。 ...

医药板块持续走高 众生药业等多股涨停 智通财经4月22日电，午后医药板块持续走高，创新药方向继续领涨，众生药业、华森制药、富士莱涨 停，百利天恒、诺诚健华、新诺威、百济神州创历史新高，复旦张江、上海谊众、信立泰、热景生物等 涨幅靠前。消息面上，4月25日至4月30日，美国癌症研究协会（AACR）年会将在芝加哥召开。作为全 球规模最大的癌症研究会议之一，AACR年会一直是癌症领域最新研究成果的重要展示平台。 ...

Investment Rating - The report indicates a positive outlook for the weight loss drug sector within the pharmaceutical and biotechnology industry, suggesting potential acceleration in business development (BD) opportunities [2]. Core Insights - The pharmaceutical and biotechnology sector experienced a slight decline of -0.36% from April 14 to April 18, underperforming compared to the Wind All A index (0.39%) and the CSI 300 index (0.59). The market showed a preference for defensive sectors, with chemical preparations (0.62%), traditional Chinese medicine (0.6%), and offline pharmacies (0.19%) showing minor gains, while blood products (-4.39%), other biological products (-1.78%), and vaccines (-1.49%) saw significant pullbacks [2][7]. - The GLP-1 receptor agonists are expected to catalyze growth in the weight loss drug sector. Notably, Eli Lilly announced positive results from the Phase III ACHIEVE-1 study for its oral drug Orforglipron, which is set to expand the application of GLP-1 drugs. This class of drugs is becoming a focal point for multinational corporations (MNCs) in the metabolic disease space, with domestic companies poised to benefit from rapid innovation and lower R&D costs [2][12]. Market Weekly Review - The pharmaceutical and biotechnology sector's performance from April 14 to April 18 showed a decline of -0.36%, with the market favoring defensive stocks. The top gainers included Shuangcheng Pharmaceutical (56.4%), Kangpeng Technology (56.3%), and Lifang Pharmaceutical (47.1%), while the largest losers were *ST Jiyuan (-50.7%), Hasanlian (-19.1%), and Changyao Holdings (-18.5%) [7][10]. Industry News and Key Company Announcements - On April 17, Eli Lilly announced that its oral GLP-1 receptor agonist Orforglipron achieved positive results in its Phase III study, showing significant reductions in A1C levels and weight loss compared to placebo [12]. - Pfizer terminated the development of its GLP-1 small molecule receptor agonist Danuglipron due to potential liver damage in trial participants [12]. - The report highlights several companies making strides in the industry, including the approval of new indications for Merck's Gardasil 9 HPV vaccine and the progress of various clinical trials for innovative drugs [13][14].

Core Insights - A total of 10 first-class innovative drugs have received clinical trial approval in China from April 14 to April 19, covering various types including small molecules, antibody-drug conjugates (ADC), gene therapy, and cell therapy, targeting conditions such as advanced solid tumors, type 1 diabetes, spinal cord injury, Duchenne muscular dystrophy (DMD), and paroxysmal nocturnal hemoglobinuria [1] Group 1: Company-Specific Developments - Hansoh Pharmaceutical's HS-10529, a KRAS G12D small molecule inhibitor, has been approved for clinical trials to treat advanced solid tumors with KRAS G12D mutations, showing good preclinical efficacy and safety [2] - Kanghong Pharmaceutical's KH815, a TROP2-targeted dual-payload ADC, has received clinical approval for treating advanced solid tumors, demonstrating potential to overcome drug resistance [3] - Innovent Biologics' IBI3020, a CEACAM5-targeted dual-payload ADC, has been approved for clinical trials aimed at treating unresectable, locally advanced, or metastatic solid tumors [4] - Xinneng Pharmaceutical's BBM-D101, an AAV gene therapy drug, has been approved for clinical trials to treat Duchenne muscular dystrophy (DMD), aiming for long-term efficacy with a single administration [5] - Zhixin Haosheng's E-islet 01, a universal allogeneic islet regeneration product, has received clinical approval for treating type 1 diabetes, utilizing advanced cell reprogramming techniques [6] - Shizhe Biotechnology's XS228, an iPSC-derived neural precursor cell injection, has been approved for clinical trials to treat subacute spinal cord injury (SCI) [7] - Baili Pharmaceutical's BL-M09D1, an ADC drug, has been approved for treating locally advanced or metastatic solid tumors, sharing technology with another ADC [8] - Renfu Innovation's HWS116, a biological product, has received clinical approval for treating advanced solid tumors, although specific mechanisms are not yet disclosed [9]

证券代码：688506 证券简称：百利天恒 公告编号：2025-032 四川百利天恒药业股份有限公司 首次公开发行部分限售股上市流通公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈 述或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 一、本次上市流通的限售股类型 根据中国证券监督管理委员会于 2022 年 11 月 23 日出具的《关于同意四川百 利天恒药业股份有限公司首次公开发行股票注册的批复》（证监许可〔2022〕2969 号），同意四川百利天恒药业股份有限公司（以下简称"公司"或"发行人"）首 次公开发行股票的注册申请。公司首次向社会公众公开发行人民币普通股（A 股） 股票 40,100,000 股，并于 2023 年 1 月 6 日在上海证券交易所科创板上市，发行完 成后总股本为 401,000,000 股，其中有限售条件流通股 367,936,702 股，无限售条 件流通股 33,063,298 股。 本次上市流通的限售股为公司首次公开发行部分限售股，限售期为自公司股 票上市之日起 12 个月。本次上市流通的限售股股东共计 5 名，限售股数量共计 10,820 ...