Core Viewpoint - China National Pharmaceutical Group (01177.HK) has received approval from the National Medical Products Administration (NMPA) for its self-developed Class 1 innovative drug, Bemosituzumab (brand name: Andevate®), for a new indication in treating patients with unresectable stage III non-small cell lung cancer (NSCLC) who do not have known epidermal growth factor receptor (EGFR) sensitive mutations or anaplastic lymphoma kinase (ALK) rearrangements after platinum-based chemoradiotherapy without disease progression [1]. Group 1 - The drug Bemosituzumab has been approved for a specific patient population, which includes those with unresectable stage III NSCLC [1]. - The approval is significant as it addresses a critical need for treatment options in patients who have not progressed after receiving platinum-based therapies [1]. - The indication specifically targets patients without known EGFR sensitive mutations or ALK rearrangements, highlighting a niche market for the drug [1].

Core Viewpoint - China National Pharmaceutical Group's innovative drug Bemosituzumab (brand name: Andevate®) has received approval from the National Medical Products Administration (NMPA) for a new indication in treating unresectable stage III non-small cell lung cancer (NSCLC) patients who have not experienced disease progression after platinum-based chemoradiotherapy [1] Group 1 - The approval is based on positive results from the R-ALPS study, which was presented at the 2025 American Society of Clinical Oncology (ASCO) annual meeting [1] - The study included patients with locally advanced or unresectable stage III NSCLC who received either Bemosituzumab or a placebo as consolidation treatment until disease progression, with the primary endpoint being progression-free survival (PFS) assessed by blinded independent central review (BICR) [1] Group 2 - The median follow-up time was 19.4 months, with a median PFS of 9.69 months for the Bemosituzumab group compared to 4.17 months for the placebo group (HR=0.53, 95% CI 0.39-0.72, p<0.0001), indicating a 47% reduction in the risk of disease progression or death [2] - Subgroup analyses showed consistent benefit trends across various groups, demonstrating the broad applicability of this treatment [2] - Overall survival (OS) data is not yet mature, with median OS not reached, but a trend towards OS benefit was observed (HR=0.76, 95% CI 0.50-1.14) [2] Group 3 - The incidence of grade 3 or higher treatment-related adverse events (TRAEs) was 29.4% in the Bemosituzumab group compared to 19.7% in the placebo group [2] - Bemosituzumab is the third PD-L1 inhibitor approved in China for consolidation treatment after radical chemoradiotherapy for locally advanced or unresectable NSCLC [2] - The company aims to continue focusing on innovation in lung cancer treatment, developing a pipeline that covers multiple molecular subtypes and treatment scenarios to enhance patient survival benefits [2]

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或因倚賴該等內 容而引致的任何損失承擔任何責任。 （於開曼群島註冊成立之有限公司） 網站：www.sinobiopharm.com （股份編號：1177） 自願公告 • 中位隨訪時間19.4個月，貝莫蘇拜單抗組中位PFS為9.69個月，安慰劑組為4.17個月（HR=0.53， 95% CI 0.39-0.72， p<0.0001 ），患者疾病進展或死亡風險降低47%； • 預設的亞組分析（是否吸煙、前序治療方式為同步╱序貫）結果顯示，各亞組與意向性治療(ITT) 人群獲益趨勢一致，展現出該治療方案的廣泛適用性； 貝莫蘇拜單抗注射液非小細胞肺癌放化療後維持適應症獲批上市 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，本集團自 主研發的國家1類創新藥貝莫蘇拜單抗（商品名：安得衛® ）新適應症已獲得中國國家藥品監督管理局 (NMPA)的上市批准，用於在接受鉑類藥物為基礎的同步或序貫放化療後未出現疾病進展的未攜帶已 ...

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]

Core Viewpoint - China Biopharmaceutical announced the latest results of a Phase III clinical study comparing Bemesumab injection combined with Anlotinib capsules to Pembrolizumab injection for first-line treatment of PD-L1 positive advanced non-small cell lung cancer (NSCLC), achieving the primary endpoint of progression-free survival (PFS) [1][2]. Group 1: Clinical Study Results - The CAMPASS study included 531 PD-L1 positive (TPS≥1%) patients with locally advanced (IIIB/C) or recurrent/metastatic NSCLC, randomized in a 2:1 ratio to receive either Bemesumab combined with Anlotinib or Pembrolizumab combined with placebo [1]. - In the overall population, the median PFS for the Bemesumab and Anlotinib group was 11.0 months, an increase of 3.9 months compared to the Pembrolizumab group (7.1 months), with a 30% reduction in the risk of disease progression/death (HR=0.70) [2]. - In the subgroup with TPS≥50%, the median PFS for the Bemesumab and Anlotinib group was extended by 6.1 months compared to the Pembrolizumab group, with a 40% reduction in the risk of disease progression/death (HR=0.60) [2]. Group 2: Safety and Tolerability - The common treatment-related adverse events in the Bemesumab and Anlotinib group were consistent with those seen in multi-targeted anti-angiogenic tyrosine kinase inhibitors (TKIs) or immunotherapy, with no new safety signals observed [3]. - Despite the extended median treatment duration due to efficacy advantages, tolerability was not significantly affected, with the rate of treatment discontinuation due to adverse events being 7.1%, lower than the Pembrolizumab group (8.0%) [3]. - The study is the first global Phase III clinical trial of an anti-PD-L1 monoclonal antibody combined with multi-targeted anti-angiogenic TKI for first-line treatment of PD-L1 positive advanced NSCLC, highlighting its significant clinical value [3].

Core Viewpoint - China Biologic Products (01177) announced positive results from a Phase III clinical trial comparing Bemesumab injection combined with chemotherapy and Anlotinib hydrochloride capsules against Tislelizumab injection combined with chemotherapy for first-line treatment of advanced squamous non-small cell lung cancer (sq-NSCLC) [1][2] Group 1: Clinical Trial Results - The trial involved 565 patients randomly assigned to treatment and control groups, showing a median progression-free survival (mPFS) of 10.12 months for the trial group compared to 7.79 months for the control group, resulting in a 36% reduction in disease progression risk [2] - The objective response rates (ORR) were 71.9% for the trial group and 65.1% for the control group, with a median duration of response (DoR) of 9.69 months versus 8.34 months, indicating a significant improvement in the trial group [2] - Subgroup analysis revealed benefits across nearly all subgroups, particularly in the PD-L1 expression 1-49% population, with a hazard ratio (HR) of 0.47 [2] Group 2: Clinical Significance - The study addresses unmet clinical needs, as lung cancer has the highest incidence and mortality rates globally, with sq-NSCLC accounting for approximately 30% of all NSCLC cases [3] - The innovative treatment regimen may change existing treatment paradigms for advanced sq-NSCLC patients, who have limited options due to low mutation rates for targeted therapies [3] - The company aims to leverage its innovation and commercialization capabilities to accelerate the global market entry of this product, benefiting more patients [3]