Core Insights - Baili Tianheng's BL-B01D1 has become the world's first dual antibody-drug conjugate (ADC) to complete Phase III clinical trials, targeting recurrent or metastatic nasopharyngeal carcinoma after failure of PD-1/PD-L1 monoclonal antibody treatment and at least two lines of chemotherapy [1][4][5] - The successful Phase III trial may position nasopharyngeal carcinoma as the primary indication for BL-B01D1, with potential for additional indications such as esophageal cancer to be analyzed in mid-2025 [1][2][5] Company Developments - Baili Tianheng's BL-B01D1 achieved a major clinical endpoint in its Phase III trial, marking a significant milestone for the company and the dual ADC category [2][3] - The company has over 30 ongoing clinical trials for BL-B01D1, including 9 Phase III trials, with the nasopharyngeal carcinoma indication being recognized as a breakthrough therapy by the National Medical Products Administration (NMPA) in April 2024 [2][5] - In 2023, Baili Tianheng entered a partnership with BMS, which included a total transaction value of $8.4 billion for the rights to BL-B01D1, making it the first dual ADC licensed from China [3][5] Industry Context - The success of BL-B01D1 in Phase III trials is seen as a validation of the quality and potential of dual ADCs globally, highlighting the strength of Chinese innovative drug assets [1][5] - The number of dual ADCs entering clinical stages globally remains limited, with only a few others, such as TQB2102 and JSKN003, also in Phase III trials [5][6] - The dual targeting nature of BL-B01D1, which targets EGFR and HER3, positions it favorably in the competitive landscape, with broad anti-tumor activity demonstrated across multiple cancer types [5]

Core Viewpoint - The Chinese innovative pharmaceutical sector is experiencing a significant moment, with multiple companies, including China Biologic Products, announcing major out-licensing deals and collaborations, indicating a strong trend towards internationalization and growth in the industry [1][2][6] Group 1: Company Developments - China Biologic Products announced at the Goldman Sachs Global Healthcare Conference that it expects at least one major out-licensing deal to be finalized this year, which is a key strategic goal for the company [2][3] - The company has identified several products with out-licensing potential, including PDE3/4, HER2 bispecific antibodies, and various ADCs, and has begun outreach to potential partners [3][4] - The stock price of China Biologic Products surged nearly 15% following the announcement of these developments, reflecting strong market interest [3] Group 2: Market Trends - The trend of out-licensing deals among Chinese innovative drug companies is gaining momentum, with several companies announcing significant transactions, such as 60.5 billion USD by 3SBio and 50 billion USD by CSPC [5][6] - In the first quarter of 2025, there were 41 out-licensing transactions in China, totaling 36.93 billion USD, indicating a rapid increase in activity compared to previous years [5] - The innovative drug sector in Hong Kong has seen substantial growth, with an ETF rising approximately 60% this year, driven by the performance of companies like 3SBio and CSPC [6] Group 3: Clinical Advancements - China Biologic Products has made significant progress in clinical trials, with its PDE3/4 inhibitor TQC3721 recently approved for Phase III trials for COPD, positioning it as a global leader in development [3][4] - The company has also received approvals for its HER2 bispecific ADC TQB2102 and is advancing multiple other projects in the ADC and bispecific antibody fields [4]

Summary of Sino Biopharmaceutical Conference Call Company Overview - **Company**: Sino Biopharmaceutical (1177.HK) - **Industry**: Pharmaceuticals, specifically focusing on oncology treatments Key Points and Arguments Clinical Efficacy - **Anlotinib and Benmelstobart Combination**: Demonstrated superior efficacy in first-line (1L) non-small cell lung cancer (NSCLC) without brain or liver metastasis compared to current standard of care (SoC) treatments - **PFS Comparison**: Anlotinib/benmelstobart combination showed a progression-free survival (PFS) of 11.0 months versus 7.1 months for Keytruda (HR=0.70) [2] - **Squamous Subtype**: Stronger PFS benefits observed in squamous subtype (HR=0.63) compared to non-squamous (HR=0.83) [2] - **Sequential Treatment**: In patients with wild-type NSCLC, the combination of benmelstobart plus chemotherapy followed by anlotinib resulted in longer PFS (10.12 months) compared to tislelizumab plus chemotherapy (7.79 months, HR=0.64) [2] Safety Concerns - **Adverse Events**: Notable safety concerns with the anlotinib/benmelstobart combination, particularly VEGF-related adverse events - **Hemoptysis**: 21.3% vs 3.4% for Keytruda - **Hypertension**: 51.1% vs 14.2% for Keytruda [2] Market Potential and Innovative Assets - **Emerging Assets**: Focus on innovative assets with global potential - **TQ05105**: First-in-class JAK/ROCK inhibitor for myelofibrosis and GVHD, currently in phase 3 trials - **TQC3721**: PDE3/4 inhibitor showing preliminary efficacy for COPD - **TQB2102**: HER2 bispecific ADC with anti-tumor effects in various solid tumors [2] Financial Outlook - **Price Target**: Buy-rated with a 12-month sum-of-the-parts (SOTP) based target price of HK$3.92 - **Valuation Breakdown**: Innovative pipeline valued at HK$41.5 billion and generics at HK$32.1 billion [7] - **Revenue Projections**: Expected revenue growth from Rmb 28.87 billion in 2024 to Rmb 37.42 billion by 2027 [10] Risks - **Key Risks**: - Broader price cuts on generics portfolio - Delays in regulatory approval for key products - Low return on R&D investment due to resource allocation issues - Below-expectation ramp-up of innovative drugs [7] Additional Important Information - **Market Capitalization**: Approximately HK$83.0 billion (US$10.6 billion) [10] - **Enterprise Value**: HK$92.1 billion (US$11.7 billion) [10] - **Analyst Contact Information**: Ziyi Chen and Honglin Yan from Goldman Sachs [4] This summary encapsulates the critical insights from the conference call regarding Sino Biopharmaceutical's clinical advancements, market positioning, financial outlook, and associated risks.

当地时间5月30日-6月3日，2025年美国临床肿瘤学会（ASCO）年会将在美国芝加哥举行。这也是全球 规模最大、最具权威性的临床肿瘤会议，其间将展示国际最前沿的临床肿瘤学科研进展和治疗成效。今 年的ASCO年会中，迪哲医药、科伦药业、中国生物制药等多家本土企业最新在研成果入选，涉及PD-1 单抗、ADC（抗体偶联药物）等领域。入选口头报告的中国研究者原创研究数量也超过去年，达70多 项。 多项研究将公布最新进展 每年的美国临床肿瘤学会，都被视为全球肿瘤领域权威的学术交流盛会，会议期间将展示国际最前沿的 临床肿瘤学科研进展和治疗成效。ASCO年会近日公布的常规摘要显示，中国研究者共计70余项原创研 究入选口头报告，数量超越去年（55项）。从目前公布的具体情况来看，部分研究有望为肿瘤患者带来 全新的治疗选择。 迪哲医药近日公告，公司自主研发的两款源头创新产品DZD8586、DZD6008将亮相ASCO年会，分别展 示在B细胞非霍奇金淋巴瘤（B-NHL）和非小细胞肺癌（NSCLC）领域的3项最新研究进展。其中，治 疗慢性淋巴细胞白血病/小淋巴细胞淋巴瘤（CLL/SLL）的汇总分析成果将以口头报告形式公布，即 DZ ...

作 者丨季媛媛 编 辑丨张星 图 源丨摄图网 当创新药行业的领军企业恒瑞医药在港股市场首日上市即收涨25%时，A股和H股市场上的创 新药板块也呈现出显著的上涨趋势。回顾整个创新药板块的市场表现，尽管在5月26日经历了 一定程度的回调，但整体来看， 创新药板块依旧是今年表现最为出色的子板块之一 ，其成绩 令人鼓舞。 根据Wind数据，截至5月26日10时30分， 恒生行业指数中的医疗保健业，年初至今涨幅已超 30% 。其中，三生制药年初至今涨幅高达210.86%、远大医药涨幅达94.17%、科伦博泰生物- B涨幅达87.88%、诺诚健华涨幅达69.28%、乐普生物-B涨幅达64.12%。另外，港股概念板块 中的未盈利生物科技指数年初至今涨幅超39%。其中，德琪医药-B年初至今涨幅达456.92%、 和铂医药-B涨幅达358.60%、加科思-B涨幅达244.88%、康宁杰瑞制药-B涨幅超148%。 面 对 市 场 表 现 ， 许 多 行 业 专 家 坦 率 表 示 ： 医 药 领 域 ， 特 别 是 创 新 药 物 ， 已 经 从 " 寒 冬"迈向"暖春"，进入了一个新的政策扶持和发展的周期。 长江证券分析认为， ...

创新药：爆款，突围，与自证 编者按：创新药行业正迎来政策扶持、产业升级与业绩回暖的"三重共振"，资本市场估值逻辑加速重 构，"熊市思维"下的传统评估方式已难适用。21世纪经济报道将持续聚焦行业热点——从BD交易模式 到全球化竞争策略，从高估值背后的风险到政策波动的应对，推出系列报道专题《创新药：爆款，突 围，与自证》，深入解读创新药企如何在变革中穿越周期，重塑价值坐标，定义行业新未来，此篇为第 一篇。 21世纪经济报道记者季媛媛 上海报道 当创新药行业的领军企业恒瑞医药在港股市场首日上市即收涨25%时，A股和H股市场上的创新药板块 也呈现出显著的上涨趋势。回顾整个创新药板块的市场表现，尽管在5月26日经历了一定程度的回调， 但整体来看，创新药板块依旧是今年表现最为出色的子板块之一，其成绩令人鼓舞。 根据Wind数据，截至5月26日10时30分，恒生行业指数中的医疗保健业，年初至今涨幅已超30%。其 中，三生制药年初至今涨幅高达210.86%、远大医药涨幅达94.17%、科伦博泰生物-B涨幅达87.88%、诺 诚健华涨幅达69.28%、乐普生物-B涨幅达64.12%。另外，港股概念板块中的未盈利生物科技指数年初 ...

May 23, 2025 04:34 AM GMT China Healthcare | Asia Pacific CSPC (+): 1) SYS6010 (EGFR ADC) in combo with SYH2051 (Ph1) showed preliminary efficacy for 2L advanced gastrointestinal cancers - mPFS of 5.8 mo in 6 gastric cancer and 4.2 mo in 9 KRAS-wt colorectal cancer pts (data not mature). G3+ TRAE rate of 48% is consistent with earlier AACR data (note), and compares favorably to Biokin's BL-B01D1. In addition, for 2L EGFRm NSCLC treatment, sac- TMT showed cORR of 45.1% and HER3-DXd showed ORR of 35.2%, which ...

点击注册小程序 查看完整报告 上周，百济神州的注射用BGB-B455、康诺亚的CM336注射液的临床申请新进承办；迪哲医药的DZD8586片、 康弘药业的KH607片的IND申请新进承办。上周，三生制药的SSGJ-707、正大天晴的TQB2102正在进行三期临 床；康宁杰瑞的KN060正在进行二期临床；绿叶制药的富马酸LPM526000133正在进行一期临床。 本周观点：商业化进程有望加速，关注外骨骼机器人在医疗康复领域应用 在医疗康复领域，外骨骼机器人主要应用于三大场景：1）脊髓损伤修复、2）脑卒中偏瘫康复、3）老龄化辅 助。全球外骨骼机器人市场正进入高速增长期，根据Grand View Research数据显示，2024年市场规模达18亿美 元，预计2030年将突破120亿美元，年复合增长率28%。叠加中国"十四五"规划将外骨骼纳入高端医疗装备重 点发展领域，多地医保已将部分康复型外骨骼纳入报销范围，我们认为外骨骼机器人在医疗康复领域的商业化 有望加速落地。 2025年年度投资策略：重塑底层逻辑，掘金支付视角 特别申明： 本订阅号中所涉及的证券研究信息由光大证券研究所编写，仅面向光大证券专业投资者客户，用 ...