Core Insights - China Biologic Products (01177.HK) announced the latest results of a Phase III clinical study for Bemesumab injection combined with or without Anlotinib capsules for the treatment of unresectable stage III non-small cell lung cancer (NSCLC) at the 2025 ASCO annual meeting [1][3] Group 1: Clinical Study Results - The study (R-ALPS) demonstrated that the combination of Bemesumab and Anlotinib significantly extended the median progression-free survival (PFS) to 15.1 months compared to 4.2 months in the placebo group, reducing the risk of disease progression or death by 51% [1][2] - A total of 553 patients were randomized in the study, with 209 in the treatment group receiving Bemesumab and Anlotinib, 212 receiving Bemesumab and placebo, and 132 in the control group receiving placebo, with a median follow-up of 19.4 months [1][2] Group 2: Safety Profile - The safety profile of the treatment was consistent with known risks, with no new safety signals reported; the incidence of grade 3 or higher treatment-related adverse events was 48.8%, 29.4%, and 19.7% for the three groups respectively [2] Group 3: Industry Context - Lung cancer has the highest incidence and mortality rates among all malignancies globally, with 2.48 million new cases reported in 2022, of which 1.061 million were in China; NSCLC accounts for approximately 80%-85% of all lung cancer cases [2] - The R-ALPS study is the first of its kind in the field of combined therapy following concurrent or sequential chemoradiotherapy for unresectable stage III NSCLC, potentially reshaping clinical practice guidelines and benefiting more NSCLC patients [3]

Group 1 - The core viewpoint of the news highlights the performance and potential of the innovative drug sector, particularly focusing on the Tianhong Innovative Drug ETF (517380), which has seen a year-to-date increase of 25.96% as of June 4, 2023 [1] - The Tianhong Innovative Drug ETF (517380) is the only ETF tracking the Hang Seng Shanghai-Shenzhen-Hong Kong Innovative Drug Selected 50 Index, which includes leading innovative drug companies from the three markets [1] - The ETF has experienced a net inflow of 11.76 million yuan recently, indicating strong investor interest and confidence in the innovative drug sector [1] Group 2 - Recent developments in domestic innovative drugs were highlighted, particularly the presentation of self-developed anti-cancer drugs by China Biopharmaceutical at the American Society of Clinical Oncology (ASCO) annual meeting [2] - The "De Fu Combination" treatment showed promising results in clinical trials, outperforming the global leader in cancer treatment, Pembrolizumab, with a median progression-free survival of 11 months [2] - Analysts from Donghai Securities and Guosheng Securities express optimism about the innovative drug sector, emphasizing its solid underlying logic and potential for continued growth despite short-term market concerns [2]

Group 1 - The Hong Kong stock market opened higher on June 5, with the Hang Seng Index rising by 0.63% and the Hang Seng Tech Index increasing by 0.65% [1] - The Hong Kong Innovative Drug ETF (159567) saw a rise of 1.26%, with a turnover rate of 16.38% and a trading volume exceeding 280 million yuan, indicating active trading [1] - Notable stocks within the ETF included Zai Lab, which rose over 7%, Hutchison China MediTech, which increased over 4%, and Luye Pharma, which gained over 3% [1] Group 2 - China National Pharmaceutical Group announced that its Bemarituzumab injection combined with Anlotinib capsules achieved a median progression-free survival (PFS) of 11 months in treating PD-L1 positive advanced non-small cell lung cancer, outperforming the global leader Pembrolizumab by 3.9 months [1] - According to Zhongtai Securities, the Chinese innovative drug industry is transitioning from a previous capital bubble to a phase of genuine results, suggesting a positive outlook for the pharmaceutical sector [1] - The report recommends actively investing in segments expected to recover, such as CRO&CDMO, upstream research, specialty raw materials, chain pharmacies, and branded OTC products [1] Group 3 - Guoyuan Securities stated that China's innovative drugs have gained recognition from large overseas pharmaceutical companies, demonstrating that the R&D capabilities are internationally competitive and a key driver for growth [2] - The innovative drug sector in China is entering a phase of realization of results, with numerous catalysts in R&D progress, which is expected to remain a main investment theme in the pharmaceutical sector through 2025 [2]

智通财经APP讯，中国生物制药(01177)发布公告，集团已在2025年美国临床肿瘤学会(ASCO)年会公布 了贝莫苏拜单抗注射液联合盐酸安罗替尼胶囊对比帕博利珠单抗注射液一线治疗PD-L1阳性晚期非小细 胞肺癌(NSCLC)的III期临床最新研究成果：达到无进展生存期(PFS)的主要研究终点，其中在TPS≥50% 的人群中，中位PFS较帕博利珠单抗组延长超过6个月，疾病进展╱死亡风险降低40%。 在安全性方面，贝莫苏拜单抗联合安罗替尼组的常见治疗相关不良事件均为多靶点抗血管生成酪氨酸激 酶抑制剂(TKI)或免疫治疗的常见不良事件，未观察到新的安全性信号。值得注意的是，尽管贝莫苏拜 单抗联合安罗替尼组因疗效优势而显著延长了中位治疗时间，但耐受性并未受到明显影响，其治疗相关 不良事件导致任意药物永久终止治疗的发生率(7.1%)和治疗相关不良事件导致死亡的发生率(1.4%)均略 低于帕博利珠单抗组(分别为8.0%和2.3%)。 CAMPASS研究是全球首个抗PD-L1单抗联合多靶点抗血管生成TKI用于PD-L1阳性晚期NSCLC一线治疗 的III期临床研究，该研究达到了PFS主要终点，尤其是对于TPS≥50%人群 ...

Policy Developments - The National Medical Products Administration (NMPA) emphasizes the need for comprehensive drug regulation reform to enhance drug safety and support high-quality development in the pharmaceutical industry [2] Drug and Device Approvals - Zai Lab's new drug application for JAK inhibitor, Tofacitinib, for treating severe alopecia areata has been accepted by the NMPA, marking its second indication for this drug [4] - Tonghua Dongbao's insulin injection has received marketing approval in Nicaragua, expanding its overseas sales potential [5] - BeiGene's new indication application for its BCL2 inhibitor, Sotorasib, for treating mantle cell lymphoma has been accepted by the NMPA [6] - Yilian Biopharma's antibody-drug conjugate targeting VEGF has received clinical trial approval in the U.S. [7] - Zhengda Tianqing's combination therapy for advanced hepatocellular carcinoma has shown positive results in a Phase III trial, with plans for a market application in November 2024 [8] - Rongchang Biopharma's clinical trial application for its ADC molecule RC278 has been accepted by the NMPA [9][10] Capital Markets - Easternova Biotechnology has submitted its IPO application to the Hong Kong Stock Exchange, focusing on regenerative medical materials [12] - China National Pharmaceutical Group plans to acquire 100% of Jinsui Technology for 302 million yuan, enhancing its e-commerce operations in health products [13] Industry Developments - Suzhou Industrial Park has launched a plan to accelerate the development of the biopharmaceutical and health industry, focusing on innovation and enterprise growth [15] - Ganli Pharmaceutical has signed a cooperation agreement with the Brazilian Ministry of Health, becoming the first Chinese pharmaceutical company to enter Brazil's PDP program [16]