Core Viewpoint - The biopharmaceutical industry in China is rapidly developing, with significant growth expected in market size from 257.65 billion yuan in 2018 to 454.17 billion yuan in 2024, and projected to reach 460 billion yuan by 2025 [1][6][4]. Group 1: Definition and Classification - Biopharmaceuticals are products used for prevention, treatment, and diagnosis, developed using principles from microbiology, biology, medicine, biochemistry, and biotechnology [2][4]. - The biopharmaceutical industry can be categorized into biopharmaceuticals, chemical drugs, and modern traditional Chinese medicine, with biopharmaceuticals further divided into blood products, recombinant proteins, vaccines, monoclonal antibodies, and cell therapy products [2]. Group 2: Current Development Status - The development of the biopharmaceutical industry is closely linked to innovations in biotechnology, with significant advancements since the 20th century [4][6]. - China's biopharmaceutical market is still in its early stages but is experiencing strong growth, with biopharmaceuticals becoming a crucial part of the pharmaceutical sector [6][4]. Group 3: Industry Chain - The upstream of the biopharmaceutical industry consists of raw materials, pharmaceutical equipment, and biotechnology, with raw materials primarily sourced from natural biological materials [8]. - The midstream involves the research and production of biopharmaceutical products, while the downstream focuses on sales channels to medical institutions, diagnostic agencies, research units, and consumers [8]. Group 4: Development Environment and Policies - Recent policies have supported and regulated the development of the biopharmaceutical industry, focusing on improving new drug pricing mechanisms, drug price governance, centralized procurement, and medical service standardization [10][12]. Group 5: Competitive Landscape - The biopharmaceutical industry is a strategic emerging industry in China, with notable companies including WuXi AppTec, HengRui Medicine, and BeiGene, among others [13][15]. - Various segments within the biopharmaceutical industry have seen the emergence of leading companies, such as vaccine producers and diagnostic reagent manufacturers [15][20]. Group 6: Development Trends - There is a strong emphasis on developing new vaccines and improving traditional vaccines to meet global health challenges [25]. - The industrialization of antibody drugs and protein drugs is advancing, with significant roles in treating various diseases [26][27]. - Research and product development in diagnostic and detection technologies for major diseases are increasingly utilizing nanomaterials for enhanced sensitivity and specificity [28].

Major Events - Silver诺医药-B (02591) is set to conduct an IPO from August 7 to August 12, with an expected listing date of August 15 [1] - Boan Biotech (06955) plans to place 48 million shares at a discount of approximately 8.78%, aiming to raise about HKD 780 million [1] - Derin Holdings (01709) intends to raise HKD 653.3 million, focusing on the development of blockchain, RWA, and virtual asset businesses [1] - Fuhong Hanlin (02696) received FDA approval to initiate a Phase 1 clinical trial for HLX43, a PD-L1 targeted antibody-drug conjugate for thymic cancer treatment [1] - China Biopharmaceutical (01177) obtained NMPA approval for the Phase II clinical trial application of LM-24C5, a dual antibody targeting CEACAM5/4-1BB [1] Financial Reports - China Mobile (00941) reported a shareholder profit of HKD 84.235 billion, a year-on-year increase of 5.03% [1] - Manulife Financial-S (00945) announced a core profit of CAD 1.7 billion for the second quarter [1] - Swire Properties (01972) reported a basic profit attributable to shareholders of HKD 4.42 billion, a year-on-year growth of 15% [1] - Hutchison Whampoa (00013) posted a net profit of USD 455 million, a significant year-on-year increase of 1663.32% [1] - MGM China (02282) disclosed a net profit of HKD 2.383 billion, a year-on-year decrease of 11.25% [1] - SMIC (00981) reported a shareholder profit of USD 132 million for the second quarter, with a revenue guidance for the third quarter indicating a sequential growth of 5% to 7% [1] - Zai Lab (09688) achieved a total revenue of approximately USD 216 million for the first half of the year, reflecting a year-on-year growth of 15.35% [1] - Innovent Biologics (01801) reported total product revenue exceeding RMB 5.2 billion for the first half of the year, maintaining a strong growth rate of over 35% [1] - Pacific Basin Shipping (02343) announced a profit attributable to shareholders of USD 25.6 million, a year-on-year decrease of 56% [1] - Lee & Man Paper Manufacturing (02314) reported a net profit of HKD 811 million, a year-on-year increase of 0.7%, with an interim dividend of HKD 0.066 per share [1] - Swire Group reported a profit attributable to shareholders of HKD 815 million for the first half of the year, a year-on-year decrease of 79% [1] - Lee & Man Chemical Company (00746) reported a profit increase of 36.0% to HKD 327 million, with an interim dividend of HKD 0.195 per share [1] - Hua Hong Semiconductor (01347) reported a profit attributable to parent company owners of USD 7.952 million for the second quarter, a year-on-year increase of 19.2% [1] - Wharf Real Estate Investment (01997) reported a loss attributable to shareholders of HKD 2.406 billion, a year-on-year increase of 128.71%, with the first interim dividend of HKD 0.066 per share [1] - Dekang Agriculture (02419) issued a profit warning, expecting a year-on-year increase in fair value adjustments of biological assets to approximately RMB 1.1 billion to 1.4 billion [1] - Mongol Mining (00975) issued a profit warning, anticipating a net loss of approximately USD 15 million to 25 million for the first half of the year, marking a shift from profit to loss [1] - Dongfeng Motor Group (00489) issued a profit warning, expecting a decline in net profit attributable to the parent company of 90% to 95% for the first half of the year [1]

Investment Rating - The report maintains an "Outperform" rating for the industry [1] Core Insights - There is an unmet clinical need in HR+/HER2- breast cancer (BC), which accounts for approximately 60-70% of all breast cancer cases globally [2][8] - New mechanism drugs are expected to extend chemotherapy-free survival for HR+/HER2- BC patients, with a focus on overcoming resistance to endocrine therapy (ET) and enhancing the efficacy of CDK4/6 inhibitors [2][40] - The report highlights the potential of various new target molecules and mechanisms to improve patient outcomes and expand market size [2][40] Summary by Sections 1. Unmet Clinical Needs in HR+/HER2- BC - HR+/HER2- BC is the most common subtype of breast cancer, with significant unmet clinical needs, especially for patients with specific mutations [2][8] - Current treatment options, including ET and CDK4/6 inhibitors, are limited for patients who progress after first-line therapy [2][40] 2. Endocrine Therapy: New Mechanism Molecules to Overcome Resistance - New generation oral SERDs and ER PROTACs are promising in overcoming resistance caused by ESR1 mutations [2][40] - The estrogen signaling pathway plays a critical role in breast cancer, and targeting this pathway is essential for effective treatment [13][48] 3. CDK Inhibitors: Partners in ET to Extend Treatment Duration - CDK4/6 inhibitors significantly improve progression-free survival (PFS) when combined with ET in first-line treatment [14][25] - There is a need for new mechanism molecules targeting the CDK-cyclin pathway to address resistance after first-line therapy [2][40] 4. Other New Target Molecules: Potential to Extend Chemotherapy-Free Survival - Activation of the PI3K/AKT/mTOR pathway is a common resistance mechanism in HR+/HER2- BC, with several products already approved for treatment [2][40] - New targets such as KAT6i and ADCs are expected to show advantages over chemotherapy and occupy significant positions in treatment sequences [2][40] 5. Company Analysis - Companies leading in the development of new mechanism drugs include BeiGene, Hansoh Pharmaceutical, Kelun-Botai Biopharmaceutical, and China National Pharmaceutical Group [2][40]

CEACAM5(癌胚抗原相关细胞黏附分子5)在多种实体瘤中高表达，包括非小细胞肺癌、结直肠癌和胃癌 等，使其成为一个极具前景的肿瘤治疗靶点。LM-24C5是礼新医药基于条件激活型4-1BB平台开发的双 特异性抗体，通过特异性结合肿瘤细胞表面的CEACAM5和免疫细胞表面的4-1BB，将免疫细胞特异性 定向至肿瘤微环境，激活并增强其抗肿瘤活性。LM-24C5的独特结构可以CEACAM5依赖性方式选择性 激活4-1BB信号通路，避免非特异性外周免疫系统激活带来的毒性风险。 临床前研究表明，LM-24C5可诱导持久的抗肿瘤免疫记忆，并与其他免疫治疗药物具有协同效应，具有 成为同类首创(First-in-Class)免疫疗法的潜力。目前，LM-24C5正在美国开展I/II期临床试验。 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)自主研发的创新药LM-24C5 "CEACAM5/4-1BB双抗"已获得中国国家药品监督管理局(NMPA)的临 床试验批准，同意其在CEACAM5阳性的晚期实体瘤患者中开展一项联合其他抗肿瘤药物的II期临床试 验。 ...

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 创新药LM-24C5"CEACAM5/4-1BB双抗"已获得中国国家药品监督管理局(NMPA)的临床试验批准，同 意其在CEACAM5阳性的晚期实体瘤患者中开展一项联合其他抗肿瘤药物的II期临床试验。 CEACAM5(癌胚抗原相关细胞黏附分子5)在多种实体瘤中高表达，包括非小细胞肺癌、结直肠癌和胃癌 等，使其成为一个极具前景的肿瘤治疗靶点。LM-24C5是礼新医药基于条件激活型4-1BB平台开发的双 特异性抗体，通过特异性结合肿瘤细胞表面的CEACAM5和免疫细胞表面的4-1BB，将免疫细胞特异性 定向至肿瘤微环境，激活并增强其抗肿瘤活性。LM-24C5的独特结构可以CEACAM5依赖性方式选择性 激活4-1BB信号通路，避免非特异性外周免疫系统激活带来的毒性风险。 临床前研究表明，LM-24C5可诱导持久的抗肿瘤免疫记忆，并与其他免疫治疗药物具有协同效应，具有 成为同类首创(First-in-Class)免疫疗法的潜力。目前，LM-24C5正在美国开展I/II期临床试验。 ...

临床前研究表明，LM-24C5可诱导持久的抗肿瘤免疫记忆，并与其他免疫治疗药物具有协同效应，具有 成为同类首创(First-in-Class)免疫疗法的潜力。目前，LM-24C5正在美国开展I/II期临床试验。 格隆汇8月7日丨中国生物制药(01177.HK)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")自主研发的创新药LM-24C5"CEACAM5/4-1BB双抗"已获得中国国家药品监督管理局(NMPA)的临 床试验批准，同意其在CEACAM5阳性的晚期实体瘤患者中开展一项联合其他抗肿瘤药物的II期临床试 验。 CEACAM5(癌胚抗原相关细胞黏附分子5)在多种实体瘤中高表达，包括非小细胞肺癌、结直肠癌和胃癌 等，使其成为一个极具前景的肿瘤治疗靶点。LM-24C5是礼新医药基于条件激活型4-1BB平台开发的双 特异性抗体，通过特异性结合肿瘤细胞表面的CEACAM5和免疫细胞表面的4-1BB，将免疫细胞特异性 定向至肿瘤微环境，激活并增强其抗肿瘤活性。LM-24C5的独特结构可以CEACAM5依赖性方式选择性 激活4-1BB信号通路，避免非特异性外周免疫系统激活带来的毒性风险。 ...

（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 LM-24C5「CEACAM5/4-1BB 雙抗」II期臨床試驗申請獲NMPA批准 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」）自主研發的創新藥LM-24C5 「CEACAM5/4-1BB雙抗」已獲得中國國家藥品監督管理局(NMPA)的臨床試驗批准，同意其在 CEACAM5陽性的晚期實體瘤患者中開展一項聯合其他抗腫瘤藥物的II期臨床試驗。 CEACAM5（癌胚抗原相關細胞黏附分子5）在多種實體瘤中高表達，包括非小細胞肺癌、結直腸癌和 胃癌等，使其成為一個極具前景的腫瘤治療靶點[1]。LM-24C5是禮新醫藥基於條件激活型4-1BB平台 開發的雙特異性抗體，通過特異性結合腫瘤細胞表面的CEACAM5和免疫細胞表面的4-1BB，將免疫 細胞特異性定向至腫瘤微環境，激活並增強其抗腫瘤活性。LM-24C5的獨特結構可以CEACAM5依 賴性方式選擇性激活4-1BB信號通路，避免非特異性外周免疫系 ...

Group 1 - The Ministry of Transport, Ministry of Finance, and Ministry of Natural Resources have issued a plan to complete the construction and renovation of 300,000 kilometers of rural roads by 2027, aiming to establish a convenient and efficient rural road network [1] - The plan includes implementing 300,000 kilometers of repair and maintenance projects, maintaining a good road condition rate of over 70%, and carrying out safety protection projects on 150,000 kilometers of roads [1] - The initiative aims to enhance rural transportation services and support the vision of a well-structured, high-quality rural transportation system by 2035 [1] Group 2 - U.S. stock markets saw an overall increase, with the Dow Jones rising by 81.38 points (0.19%) and the Nasdaq increasing by 252.87 points (1.21%) [2] - Notable stock movements included Apple rising by 5% due to anticipated investments in U.S. manufacturing, and McDonald's gaining over 3% following better-than-expected earnings [2] - Many popular Chinese concept stocks also saw gains, with Alibaba up over 3% and NIO increasing by over 2% [2] Group 3 - The State Grid reported a record high electricity load for three consecutive days, reaching a maximum load of 1.233 billion kilowatts, an increase of 53 million kilowatts compared to last year's peak [3] - The electricity load is expected to remain above 1.2 billion kilowatts, with a potential decrease anticipated due to upcoming rainfall and cooler temperatures [3] Group 4 - The Hong Kong Monetary Authority intervened in the currency market, buying HKD 8.439 billion after the Hong Kong dollar hit the weak end of its trading band [4] - This action is part of the linked exchange rate system, where the HKMA sells USD and buys HKD to stabilize the currency [4] Group 5 - The China Photovoltaic Industry Association is soliciting opinions on the draft amendment to the Price Law, focusing on price behavior norms and regulatory mechanisms [5] - This initiative aims to reflect the demands of the photovoltaic industry and gather feedback for potential modifications [5] Group 6 - Guangnan Group's subsidiary successfully acquired land use rights in Foshan for RMB 56.16 million, expanding its meat industry chain [6] Group 7 - Caocao Travel is exploring the tokenization of real-world assets and stablecoin payments through a strategic partnership with a licensed financial institution in Hong Kong [7][8] Group 8 - Lianzhong is integrating AI technology into traditional board games, collaborating with tech companies to enhance gaming experiences [9] Group 9 - China National Pharmaceutical Group's self-developed drug TQ05105 has been included in the breakthrough therapy designation program for chronic graft-versus-host disease treatment [10] Group 10 - China Nuclear Technology expects a mid-year profit increase of no less than 15% compared to the previous year [11] Group 11 - Hengrui Medicine's product received orphan drug designation from the FDA, which may provide regulatory advantages in the U.S. market [12] Group 12 - Huaxian Optoelectronics anticipates a significant profit increase of at least 600% for the first half of 2025 [13] Group 13 - New World Development expects a mid-year profit of no less than HKD 800 million, a substantial increase from the previous year's HKD 75.4 million [14] Group 14 - Xinwei Medical expects to achieve a net profit of at least RMB 40 million in the first half of 2025, marking a turnaround from losses [15] Group 15 - Zhiyu Technology anticipates a mid-year profit increase of approximately 108.9% to 126.7% [16] Group 16 - Ningmeng Media expects to achieve a net profit of approximately RMB 10 million to 12 million in the first half of 2025, reversing previous losses [17] Group 17 - Weixin Jinke anticipates a significant profit increase of no less than RMB 200 million for the first half of 2025, reflecting a growth of at least 65% [18] Group 18 - Uni-President China reported a 33.24% increase in shareholder profit to RMB 1.287 billion for the mid-year period [19] Group 19 - BeiGene reported a net profit of USD 94.32 million for the second quarter, marking a turnaround from a loss of USD 120 million in the previous year [20] Group 20 - Maifushi expects to achieve a net profit of approximately RMB 31.8 million to 41 million in the first half of 2025, reversing a significant loss from the previous year [21]

Major Events - Cathay Pacific (00293) has purchased fourteen Boeing 777-9 aircraft [1] - Hengrui Medicine (01276) received FDA orphan drug designation for the combination of injection Rituximab and chemotherapy for gastric cancer or gastroesophageal junction adenocarcinoma [1] - China National Pharmaceutical Group's self-developed drug TQ05105 (JAK/ROCK inhibitor) has been included in the breakthrough therapy designation program [1] - Junshi Biosciences (02696) completed the first patient dosing in a Phase II clinical study of HLX79 injection combined with Hanli Kang® for active glomerulonephritis in China [1] - YingTai Medical (01501) plans to invest no more than 110 million yuan to establish the Huai Ge Guang Tai Fund [1] - JinJing New Energy (01783) proposed a stock split [1] Financial Data - Cathay Pacific (00293) reported a mid-term profit attributable to shareholders of 3.651 billion HKD, a year-on-year increase of 1.1%, with an interim dividend of 0.20 HKD per share [1] - Uni-President Enterprises China (00220) reported a mid-term profit attributable to shareholders of 1.287 billion CNY, a year-on-year increase of 33.24% [1] - BeiGene (06160) reported a net profit of 94.32 million USD for the second quarter, returning to profitability year-on-year [1] - Sun Hung Kai Properties (00086) issued a profit warning, expecting mid-term profit attributable to shareholders to increase to no less than 800 million HKD year-on-year [1] - Weixin Jinke (02003) issued a profit warning, expecting mid-term comprehensive net profit to be no less than 200 million CNY, a significant year-on-year increase [1] - ZhiZi Cheng Technology (09911) issued a profit warning, expecting mid-term profit attributable to shareholders to increase by approximately 108.9% to 126.7% year-on-year [1] - China Star Optoelectronics (00334) issued a profit warning, expecting a year-on-year increase of no less than 600% in profit attributable to the parent company for the first half of the year [1] - Xinli International (00732) reported a total operating revenue of approximately 1.468 billion HKD in July, a year-on-year decrease of about 3.3% [1]

Major Events - Cathay Pacific (00293) has purchased fourteen Boeing 777-9 aircraft [1] - Hengrui Medicine (01276) received FDA orphan drug designation for the combination of injection Rituximab and chemotherapy for gastric cancer or gastroesophageal junction adenocarcinoma [1] - China National Pharmaceutical Group (01177) has its self-developed drug TQ05105 (JAK/ROCK inhibitor) included in the breakthrough therapy designation program [1] - Junshi Biosciences (02696) completed the first patient dosing in a Phase II clinical study of HLX79 injection combined with Hanli Kang® for active glomerulonephritis in China [1] - YingTai Medical (01501) plans to invest no more than 110 million yuan to establish the Huai Ge Guang Tai Fund [1] - JinJing New Energy (01783) proposed a stock split [1] Financial Data - Cathay Pacific (00293) reported a mid-term profit attributable to shareholders of 3.651 billion HKD, a year-on-year increase of 1.1%, with an interim dividend of 0.2 HKD per share [1] - Uni-President Enterprises China (00220) reported a mid-term profit attributable to shareholders of 1.287 billion CNY, a year-on-year increase of 33.24% [1] - BeiGene (06160) reported a net profit of 94.32 million USD in the second quarter, returning to profitability year-on-year [1] - New World Development Company (00086) issued a profit warning, expecting mid-term profit attributable to shareholders to increase to no less than 800 million HKD year-on-year [1] - Weixin Jinkao (02003) issued a profit warning, expecting mid-term comprehensive net profit to be no less than 200 million CNY, a significant year-on-year increase [1] - ZhiZi Cheng Technology (09911) issued a profit warning, expecting mid-term profit attributable to shareholders to increase by approximately 108.9% to 126.7% year-on-year [1] - Huaxian Optoelectronics (00334) issued a profit warning, expecting a year-on-year increase of no less than 600% in profit attributable to the parent company [1] - Xinli International (00732) reported a total operating revenue of approximately 1.468 billion HKD in July, a year-on-year decrease of about 3.3% [1]