Investment Rating - The report maintains an "Accumulate" rating for the pharmaceutical and biotechnology sector [4]. Core Viewpoints - The domestic weight loss drug market is entering commercialization, emphasizing the importance of sales capabilities for companies [1][19]. - The competition in the global weight loss drug market is intensifying, particularly between Novo Nordisk and Eli Lilly, where marketing strategies play a crucial role in sales performance [19][23]. - Companies with advanced R&D progress and strong sales execution will hold competitive advantages in the commercialization phase of weight loss drugs [1][19]. Summary by Sections Market Review - The pharmaceutical and biotechnology index rose by 1.16%, outperforming the CSI 300 index by 0.77 percentage points but underperforming the ChiNext index by 1.08 percentage points, ranking 15th among 31 sub-industries [1][15]. - The Hong Kong Hang Seng Healthcare Index increased by 8.44%, outperforming the Hang Seng Index by 6.12 percentage points [1][15]. Company Updates - Recent clinical application updates include Baiyi Shenzhou's injection BGB-B2033 and Nuo Cheng Jian Hua's injection ICP-B794, both newly undertaken [27]. - Ongoing clinical trials include Bo Rui Pharmaceutical's BGM0504 and Hua Dong Pharmaceutical's HDM1002, currently in Phase III [27]. Investment Strategy - The report suggests a structural selection of investment opportunities based on payment willingness and ability, focusing on three payment channels: in-hospital payments, out-of-pocket payments, and overseas payments [2]. - Key recommended companies include Heng Rui Pharmaceutical, Mai Rui Medical, and United Imaging Healthcare [2]. Company Profit Forecasts and Valuation - Heng Rui Pharmaceutical is rated "Accumulate" with a projected EPS of 0.99 yuan for 2024 and a PE ratio of 51 [3]. - Mai Rui Medical is rated "Buy" with a projected EPS of 11.47 yuan for 2024 and a PE ratio of 19 [3]. - United Imaging Healthcare is also rated "Buy" with a projected EPS of 2.88 yuan for 2024 and a PE ratio of 44 [3].

Investment Rating - The industry investment rating is "stronger than the market" [3][47]. Core Viewpoints - The approval of Ivosidenib for first-line treatment of NSCLC in China is a significant milestone, being the first to show positive results in a clinical trial comparing it to Pembrolizumab [3]. - The HARMONi-2 trial demonstrated that Ivosidenib significantly improved progression-free survival (mPFS of 11.14 months vs. 5.82 months for Pembrolizumab), with a hazard ratio (HR) of 0.51, indicating a 49% reduction in the risk of disease progression or death [3]. - The interim analysis of overall survival (OS) at 39% maturity showed a 22.3% reduction in mortality risk for Ivosidenib compared to Pembrolizumab (HR=0.777) [3]. Summary by Sections Industry News - Ivosidenib has received approval for a new indication in first-line treatment of PD-L1 positive locally advanced or metastatic NSCLC based on the HARMONi-2 trial results [3]. - The trial involved a randomized comparison of Ivosidenib and Pembrolizumab, with primary endpoints focused on progression-free survival (PFS) [3]. - Additional studies have shown Ivosidenib's efficacy in various NSCLC settings, including in combination with chemotherapy [4]. Investment Strategy - The report suggests focusing on "innovation," "overseas expansion," "equipment upgrades," and "consumption recovery" as key investment themes [6]. - Companies to watch include innovative drug developers and those with strong overseas market potential, such as BeiGene, Dongcheng Pharmaceutical, and others [6]. Key Companies to Watch - **Nocera Healthcare**: Expected to achieve over 1 billion yuan in revenue from its core product, with a 49% year-on-year growth in sales [7]. - **Sihuan Pharmaceutical**: Strong fundamentals with a stable growth outlook, particularly in the ADC market [10]. - **China Biopharmaceutical**: Rapid revenue growth with a focus on innovative products, particularly in oncology [11]. - **Aier Eye Hospital**: Benefiting from increasing demand for eye care services and a strong pipeline of new products [20].

Investment Rating - The report does not explicitly state an investment rating for the industry, but it suggests a long-term focus on domestic innovative drugs in the oncology field and AI medical investment opportunities [3][4]. Core Insights - The pharmaceutical and biotechnology sector saw a weekly increase of 1.16%, outperforming the Wind All A index (1.15%) and the CSI 300 index (0.38%) [3][8]. - The upcoming ASCO conference is highlighted as a significant event for domestic innovative drug companies, with over 70 oral presentations and more than 10 major studies expected [3][4]. - The Ministry of Industry and Information Technology and six other departments issued a plan for the digital transformation of the pharmaceutical industry, aiming for significant advancements by 2027 and full coverage by 2030 [3][4]. Market Weekly Review - The pharmaceutical and biotechnology sector increased by 1.16% from April 21 to April 25, outperforming the Wind All A index and the CSI 300 index [3][8]. - Notable performers included medical research outsourcing (6.34%) and raw materials (4.72%), while blood products (-3.26%) and vaccines (-6.38%) continued to decline [3][9]. - Individual stock performances showed significant gains for Yong'an Pharmaceutical (31.4%), Shuyou Shen (28.4%), and Erkang Pharmaceutical (27.7%), while *ST Jiyuan (-43.2%), Nanhua Biological (-35.3%), and Shuangcheng Pharmaceutical (-27.7%) faced substantial losses [3][11]. Industry News and Key Company Announcements - On April 25, Kangfang Bio announced FDA approval for its drug Anike for the treatment of recurrent or metastatic nasopharyngeal carcinoma [12]. - The same day, Kangfang Bio also reported the approval of its PD-1/VEGF bispecific antibody for first-line treatment of specific lung cancer types [13]. - The digital transformation plan for the pharmaceutical industry aims to enhance competitiveness and quality management through AI and data integration by 2030 [3][4].

Investment Rating - The report maintains an "Overweight" rating for the pharmaceutical and biotechnology industry [1]. Core Insights - The approval of 康方生物's依沃西单抗 for first-line treatment of PD-L1 positive non-small cell lung cancer (NSCLC) has significantly increased global interest in PD-1/VEGF dual antibodies, indicating a promising investment opportunity in this sector [21][23]. - The report highlights the strong performance of the A-share pharmaceutical index, which has increased by 1.2% this week and decreased by 0.3% year-to-date, outperforming the CSI 300 index by 0.8% and 3.5% respectively [4][9]. - The report suggests a ranking of favored sub-industries as follows: innovative drugs > CXO > traditional Chinese medicine > medical devices > pharmacies > pharmaceutical commerce [10][11]. Summary by Sections Industry Trends - The A-share pharmaceutical index has shown a weekly increase of 1.2% and a year-to-date decrease of 0.3%, while the H-share biotechnology index has increased by 9% this week and 30% year-to-date, outperforming the Hang Seng Technology Index by 7% and 18.5% respectively [4][9]. - Specific sectors such as raw materials (+4.7%), medical services (+3.4%), and chemical drugs (+2.7%) have seen significant price increases, while pharmaceutical commerce (-0.3%), traditional Chinese medicine (-0.5%), and biological products (-0.9%) have experienced declines [4][9]. Research and Development Progress - 康方生物's依沃西单抗 has been approved for use in treating PD-L1 positive NSCLC, marking a significant milestone in the development of PD-1/VEGF dual antibodies [21]. - The report notes that several companies, including 三生制药 and 宜明昂科, are advancing their PD(L)1/VEGF dual antibodies through various clinical stages, indicating a competitive landscape in this therapeutic area [23]. Investment Strategy - The report recommends focusing on growth-oriented stocks primarily in the innovative drug sector, with specific mentions of companies such as 信达生物, 康方生物, and 恒瑞医药 [11]. - For undervalued stocks, the report suggests looking into traditional Chinese medicine companies like 佐力药业 and 东阿阿胶, while high-dividend stocks are recommended from the same sector, including 江中药业 and 云南白药 [11].

Investment Rating - The report maintains an investment rating of "Outperform the Market - A" for the biopharmaceutical sector [6]. Core Insights - The ASCO 2025 conference is set to take place from May 30 to June 3, 2025, and several domestic pharmaceutical companies are expected to present new clinical data, with potential for exceeding expectations [2][14]. - A total of 13 new drugs or new indications were approved for market launch in the past week, alongside 50 new drug IND approvals and 27 IND applications accepted [3][17]. Weekly New Drug Market Review - From April 21 to April 27, 2025, the top five companies in the new drug sector by stock price increase were: - Yiming Oncology: +40.20% - Ascentage Pharma: +38.63% - Genscript Biotech: +27.13% - JACOB: +24.52% - Kedi: +24.02% - The top five companies by stock price decrease were: - Boan Biotech: -23.11% - ZhiXiang JinTai: -7.30% - Maibo Pharmaceutical: -7.07% - Aidi Pharmaceutical: -6.30% - Haizhi Pharmaceutical: -3.76% [10][11]. Weekly New Drug Industry Key Analysis - The ASCO 2025 conference will feature multiple oral presentations from domestic companies, including: - Innovent Biologics: PD-1/IL-2 dual antibody with three oral reports and Claudin18.2 ADC with one oral report. - Other companies such as Kelun Biotech, BaiLi TianHeng, and Hengrui Medicine are also expected to present various new drugs and indications [2][14][15]. Weekly New Drug Approvals & Acceptance - The report highlights the approval of 13 new drugs or new indications, including: - Canfuo Biotech's PD-1/VEGF dual-specificity tumor immunotherapy drug approved for new indications. - AstraZeneca's Dupixent for chronic spontaneous urticaria in patients aged 12 and older [4][18]. - Additionally, 50 new drug INDs were approved, and 27 IND applications were accepted [3][17]. Domestic New Drug Industry Focus - Key highlights include: - Canfuo Biotech's PD-1 monoclonal antibody approved by the FDA for metastatic nasopharyngeal carcinoma. - Canfuo Biotech's new indication for its PD-1/VEGF dual-specificity drug approved by NMPA for non-small cell lung cancer. - Novartis' BTK inhibitor approved for chronic lymphocytic leukemia [4][18]. Overseas New Drug Industry Focus - Notable developments include: - Sanofi's Dupixent for chronic spontaneous urticaria approved by the FDA. - AstraZeneca's Enhertu showing positive results in clinical trials for HER2-positive metastatic breast cancer. - Gilead Sciences' Trodelvy achieving positive results in clinical studies [5][7].

证券研究报告 | 医药生物 | 2025年4月26日 www.hczq.com 华创医药投资观点&研究专题周周谈·第123期 华海药业创新研发进入收获期 本周周专题联系人：王宏雨 | 华创医药团队： | | | --- | --- | | 首席分析师 郑辰 | 执业编号: S0360520110002 邮箱: zhengchen@hcyjs.com | | 联席首席分析师 刘浩 | 执业编号: S0360520120002 邮箱: liuhao@hcyjs.com | | 医疗器械组组长 李婵娟 | 执业编号: S0360520110004 邮箱: lichanjuan@hcyjs.com | | 中药和流通组组长 高初蕾 | 执业编号：S0360524070002 邮箱：gaochulei@hcyjs.com | | 分析师 王宏雨 | 执业编号: S0360523080006 邮箱: wanghongyu@hcyjs.com | | 分析师 朱珂琛 | 执业编号: S0360524070007 邮箱: zhukechen@hcyjs.com | 本报告由华创证券有限责任公司编制 报告仅供华创证券有限责任公 ...

Core Viewpoint - The approval of the new BTK inhibitor, Oubatinib (brand name: Yinuokai), by the National Medical Products Administration (NMPA) in China for first-line treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) represents a significant advancement in the treatment options available for lymphoma patients [1] Group 1: Company Overview - Nocare Biopharma (stock codes: 688428 on SSE; 09969 on HKEX) is a biopharmaceutical high-tech company focused on the development of innovative drugs for malignant tumors and autoimmune diseases [3] - The company has multiple new drug products at various stages of commercialization, clinical trials, and preclinical research, with branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States [3] Group 2: Product Approval and Impact - Oubatinib has previously been approved in China for treating relapsed/refractory CLL/SLL, mantle cell lymphoma (R/R MCL), and marginal zone lymphoma (R/R MZL), all of which are included in the national medical insurance [1] - The first-line approval for CLL/SLL is expected to benefit a larger number of lymphoma patients, with clinical trials showing a complete remission rate of 12.1% [1] - Experts have highlighted Oubatinib's high selectivity and low off-target effects, which enhance its efficacy and safety in treating blood cancers [1] Group 3: Clinical Research and Expert Opinions - Clinical researchers noted that Oubatinib demonstrated significant efficacy and safety even during the challenges posed by the COVID-19 pandemic, confirming its innovative nature [1] - The drug has been included as a Class I recommendation in the CSCO lymphoma treatment guidelines for first-line therapy of CLL/SLL, indicating its recognized importance in clinical practice [1] - Experts anticipate that the accumulation of real-world data will further guide clinical practices and improve treatment options for more lymphoma patients [1]

| A | 股代码：688428 | 股简称：诺诚健华 A | 公告编号：2025-013 | | --- | --- | --- | --- | | 港股代码：09969 | | 港股简称：诺诚健华 | | 诺诚健华医药有限公司 自愿披露关于奥布替尼新适应症 在中国上市申请获得批准的公告 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。 近日，诺诚健华医药有限公司（以下简称"公司"或"诺诚健华"）收到国家药 品监督管理局（NMPA）核准签发的《药品注册证书》，奥布替尼（商品名：宜 诺凯®）用于一线治疗慢性淋巴细胞白血病/小淋巴细胞淋巴瘤（以下简称 "CLL/SLL"）的新适应症上市申请获得批准。现将相关情况公告如下： 一、药品情况 药品名称：奥布替尼片 申请事项：药品注册（境内生产） 受理号：CXHS2400078 证书编号：2025S01123 上市许可持有人：北京诺诚健华医药科技有限公司 审批结论：批准增加适应症，新增适应症为：本品单药适用于成人慢性淋巴 细胞白血病（CLL）/小淋巴细胞淋巴瘤（SLL）患者。 二、药品 ...

Group 1 - The Hong Kong innovative drug sector has rebounded rapidly due to a favorable external environment, with the China Securities Hong Kong Innovative Drug Index (931787) experiencing a significant recovery since its low on April 9, 2023 [1][3] - As of April 25, 2023, the index reached a peak of 979.92 points, showing a maximum cumulative increase of 37.43% from its previous low [1] - The overall increase in the Hong Kong innovative drug sector has outperformed the Hang Seng Technology Index, which has only seen a year-to-date increase of 12.48% compared to the innovative drug index's 31.03% [3] Group 2 - Recent data indicates a collective performance improvement among Hong Kong innovative drug companies, significantly exceeding market expectations [4] - In 2024, 10 out of 12 Hong Kong innovative drug companies with a market capitalization over 10 billion HKD reported positive revenue growth, with 8 companies also showing positive profit growth [4] - The company with the highest revenue growth is CloudTop New Drug-B (01952), with a revenue growth rate of 341.8%, while Innovent Biologics (01801) reported a net profit growth of 91.8% [4] Group 3 - The trend of "going global" has become a key topic, with Chinese pharmaceutical companies achieving significant growth in overseas licensing transactions [6][8] - The total transaction amount for licensing-out by Chinese pharmaceutical companies reached a historical high of 51.9 billion USD in 2024, indicating a strong global competitiveness in innovative drug development [6] - The NewCo model has emerged as a favorable strategy for domestic biotech companies, allowing for cash flow support and risk sharing in international collaborations [8] Group 4 - New industry trends in pharmaceuticals, such as weight-loss drugs, dual-antibody drugs, ADC drugs, and innovative medical devices, are expected to create new investment opportunities [9] - The Chinese government is increasing support for innovative drug exports, as evidenced by recent policies aimed at facilitating the import of research materials for biopharmaceutical companies [9] - Despite market fluctuations due to trade tensions, the pharmaceutical sector remains relatively insulated, presenting a favorable opportunity for large-scale investments [9] Group 5 - The Hong Kong innovative drug sector is poised for a valuation recovery, with significant inflows of capital from southbound investors since the beginning of the year [11] - As of April 24, 2023, net capital inflows from A-share investors into Hong Kong stocks reached 611.1 billion HKD, with healthcare becoming the second most net inflow sector [11] - The current price-to-earnings ratio (TTM) for the pharmaceutical and biotechnology sector is 27.1, indicating that the sector is undervalued compared to other growth sectors [12][13]

Group 1 - The core viewpoint of the news is the performance and holdings of the Huatai-PineBridge Medical Services Flexible Allocation Mixed A Fund, which has shown significant returns in recent months and has a strong portfolio in the healthcare sector [1][3]. - As of April 24, 2025, the fund's latest net value is 1.5450 yuan, reflecting a growth of 1.25% [1]. - The fund has achieved a return of 18.21% over the past month, ranking 2 out of 8 in its category, and a return of 30.60% over the past three months, ranking 1 out of 8 [1]. - Year-to-date, the fund has returned 28.32%, also ranking 1 out of 8 in its category [1]. Group 2 - The top ten stock holdings of the fund account for a total of 64.17%, with significant positions in companies such as Heng Rui Pharmaceutical (10.23%), Kelun Pharmaceutical (9.09%), and Bai Li Tianheng (8.94%) [1]. - The fund was established on June 18, 2015, and as of March 31, 2025, it has a total asset size of 4.408 billion yuan [1]. - The fund manager, Zhang Wei, has a strong background in biomedical studies and has held various positions in the pharmaceutical research field prior to managing this fund [2].