申万宏源主要观点如下： 再鼎医药为一家处于商业化阶段的创新型全球生物制药公司。凭借授权引进(license-in)与自主研发，目 前公司共有七款产品于国内获批上市，包括四款肿瘤产品(则乐、爱普盾、擎乐、奥凯乐)、一款免疫产 品(艾加莫德)，以及两款感染性疾病产品(纽再乐、鼎优乐)。此外，公司拥有涵盖肿瘤、免疫、神经科 学和感染性疾病的广泛产品管线。 核心产品持续销售放量，新产品有望进一步丰富产品组合 2019年以来，随着首款商业化产品尼拉帕利于国内获批上市，目前公司已有七款商业化产品。2024年公 司总收入达到3.99亿美元，同比增长50%，主要由于卫伟迦/卫力迦、纽再乐等产品销售放量。新产品方 面，公司已于今年上半年向NMPA递交了KarXT和维替索妥尤单抗(TF ADC)的上市申请。此外，公司预 计将于今年下半年向NMPA递交贝玛妥珠单抗针对1L胃癌的上市申请。随着现有商业化产品的销售放 量，以及Kar-XT、贝玛妥珠单抗、ZL-1310(DLL3ADC)、povetacicept等新产品未来获批上市，公司预计 2028年营收有望达到20亿美元。 申万宏源发布研报称，随着商业化产品的销售放量，以及本地化生 ...

智通财经APP获悉，申万宏源发布研报称，随着商业化产品的销售放量，以及本地化生产布局，再鼎医 药(09688)预计将于2025年四季度实现non-GAAP经营利润。此外，该行预计2025-2027年公司收入分别 为5.53亿美元，8.02亿美元和12.03亿美元，2025-2027年公司归母净利润分别为-1.34亿美元、0.15亿美元 和1.73亿美元。基于DCF模型，给予目标价35.2港元。目标价对应39%的上涨空间，看好公司的创新管 线布局，首次覆盖给予买入评级。 申万宏源主要观点如下： 再鼎医药为一家处于商业化阶段的创新型全球生物制药公司。凭借授权引进（license-in）与自主研发， 目前公司共有七款产品于国内获批上市，包括四款肿瘤产品（则乐、爱普盾、擎乐、奥凯乐）、一款免 疫产品（艾加莫德），以及两款感染性疾病产品（纽再乐、鼎优乐）。此外，公司拥有涵盖肿瘤、免 疫、神经科学和感染性疾病的广泛产品管线。 核心产品持续销售放量，新产品有望进一步丰富产品组合 2019年以来，随着首款商业化产品尼拉帕利于国内获批上市，目前公司已有七款商业化产品。2024年公 司总收入达到3.99亿美元，同比增长50%，主 ...

Investment Rating - The report initiates coverage with a "Buy" rating for the company [5][11]. Core Insights - The company is positioned to reach a profitability inflection point due to its differentiated innovative pipeline and ongoing commercialization of its products [2][13]. - The company expects significant revenue growth, projecting revenues of $3.99 billion in 2024, $5.53 billion in 2025, $8.02 billion in 2026, and $12.03 billion in 2027, with a potential revenue of $2 billion by 2028 [2][5][11]. Summary by Sections Product Pipeline and Commercialization - The company has seven products approved for sale in China, including four oncology products, one immunology product, and two infectious disease products [2][27]. - The core products are experiencing strong sales growth, with a projected revenue increase of 50% year-over-year in 2024, driven by products like Weiwei Jia and Niu Zai Le [2][30]. - The company has submitted applications for new products, including KarXT and TF ADC, and anticipates further submissions for other products [2][12]. Financial Projections - The company forecasts revenues of $5.53 billion, $8.02 billion, and $12.03 billion for 2025, 2026, and 2027, respectively, with net profits expected to turn positive by 2027 [5][11]. - The report indicates that the company will achieve non-GAAP operating profit by Q4 2025, supported by local production and increasing product sales [41]. Market Position and Valuation - The company's current stock price reflects a valuation of 7 times the 2025 price-to-sales ratio, compared to an average of 18 times for comparable companies, indicating attractive valuation [11]. - The target price is set at HKD 35.2, representing a 39% upside potential from the current price [5][11]. Key Product Highlights - Efgartigimod (艾加莫德) is expected to become a leading product in the autoimmune field, with significant sales growth projected due to new indications and formulations [3][12]. - ZL-1310 (DLL3 ADC) has shown promising clinical data and is expected to enter critical global studies [4][38]. - The company is actively expanding its global pipeline, focusing on ADCs and bispecific antibodies, with multiple products in various stages of clinical development [4][38].

Core Viewpoint - Zai Ding Pharmaceutical (09688) shares rose over 5%, currently up 5.38% at HKD 25.48, with a trading volume of HKD 224 million [1] Group 1: Clinical Research Updates - Recently, Zai Ding Pharmaceutical announced that its partner Amgen has completed the final analysis of the FORTITUDE-101 Phase III clinical study, which evaluates the efficacy of Bemarituzumab combined with chemotherapy (mFOLFOX6) for first-line treatment of gastric cancer [1] - The interim analysis showed significant statistical and clinical improvement in overall survival with the Bemarituzumab combination compared to chemotherapy alone; however, the survival benefit observed in the interim analysis weakened in the final analysis [1] - Amgen stated that the results of both the interim and final analyses will be presented at an upcoming major medical conference [1] Group 2: Future Research Plans - Based on the updated results from the FORTITUDE-101 study, the company plans to wait for the results of the FORTITUDE-102 study, which aims to evaluate Bemarituzumab combined with Nivolumab and chemotherapy for the same patient population, before submitting a registration application [1] - Data from the FORTITUDE-102 study is expected to be released by the end of 2025 or in the first half of 2026 [1]

Core Viewpoint - Zai Ding Pharma (09688) shares rose over 5%, reaching HKD 25.48 with a trading volume of HKD 224 million following the announcement of the final analysis of the FORTITUDE-101 Phase III clinical trial for Bemarituzumab combined with mFOLFOX6 in first-line gastric cancer treatment [1] Group 1: Clinical Trial Results - The FORTITUDE-101 trial showed significant statistical and clinical improvement in overall survival when comparing Bemarituzumab combined with chemotherapy to chemotherapy alone during the pre-set interim analysis [1] - However, the final analysis indicated a reduction in the previously observed survival benefit [1] - Amgen, the partner and sponsor of the study, plans to present the results of both the interim and final analyses at an upcoming major medical conference [1] Group 2: Future Plans - The company intends to wait for the results of the FORTITUDE-102 study, which evaluates Bemarituzumab combined with Nivolumab and chemotherapy for the same patient population, before submitting a registration application [1] - Data from the FORTITUDE-102 study is expected to be available by the end of 2025 or the first half of 2026 [1]

Investment Rating - The report indicates a positive outlook for the pharmaceutical and biotechnology sector, with a weekly increase of 1.4%, outperforming the Wind All A index (-1.37%) and the CSI 300 index (-0.81%) [3][8]. Core Insights - The report highlights the acceleration of business development (BD) in small nucleic acid drugs, with significant deals announced by Arrowhead Pharmaceuticals and Novartis, indicating a strong interest in this area from multinational corporations [3][12]. - The report emphasizes the importance of the World Conference on Lung Cancer (WCLC) held from September 6-9, where several key research advancements in lung cancer were presented, suggesting potential investment opportunities in innovative drug companies participating in the conference [3][11]. - The report notes the strong performance of specific stocks within the sector, such as Haichen Pharmaceutical (28.7%), Changchun High-tech (24.2%), and Baihua Pharmaceutical (21.3%), while also identifying underperformers like Shuyou Shen (24%) and Guangsheng Tang (15.8%) [3][11]. Market Weekly Review - The pharmaceutical and biotechnology sector saw a weekly increase of 1.4%, with the best-performing sub-sectors being other biological products (4.86%), chemical products (4.52%), and medical research outsourcing (3.78%) [3][8]. - Conversely, sectors such as hospitals (-2.31%), vaccines (-2.08%), and medical devices (-1.97%) experienced declines [3][8]. - Notable individual stock performances included significant gains for Haichen Pharmaceutical, Changchun High-tech, and Baihua Pharmaceutical, while Shuyou Shen and Guangsheng Tang faced substantial losses [3][11]. Industry News and Key Company Announcements - Arrowhead Pharmaceuticals announced a global licensing and collaboration agreement with Novartis for a siRNA therapy targeting Parkinson's disease, with an upfront payment of $200 million and potential milestone payments totaling up to $2 billion [3][15]. - A strategic collaboration was established between Novartis and Wobang Pharmaceuticals for cardiovascular products, with an upfront payment of $160 million and potential total milestone payments of $5.2 billion [3][13]. - The report also mentions various clinical trial advancements and approvals for several companies, including the approval of new indications for existing drugs and the initiation of new clinical trials [3][16].

Market Overview - The Hong Kong stock market continued its downward trend, with the Hang Seng Index falling 1.12% to stay above the 25,000-point mark, while the Hang Seng China Enterprises Index dropped 1.25% and the Hang Seng Tech Index fell 1.85% [1] Technology Sector - Major technology stocks mostly declined, with Alibaba down over 3%, Kuaishou and Xiaomi Group down over 2%, and Tencent Holdings down 1%. Meituan saw a slight increase, while Baidu rose over 2% [2] Semiconductor Sector - Semiconductor and chip stocks experienced significant declines, with Jingmen Semiconductor and Innodisk down over 7%. Other companies like SMIC, Shanghai Fudan, Huahong Semiconductor, and China Electronics Technology also followed suit [3] Oil Sector - Oil stocks fell, with China Petroleum & Chemical Corporation, China National Petroleum Corporation, and CNOOC down over 1%. Analysts expect OPEC+ to consider increasing production targets in their upcoming meeting, contributing to the decline in oil prices [4] Gold Sector - Gold stocks saw a sharp decline, with Tongguan Gold down nearly 9%. The spot gold market has been volatile, with prices dropping 0.27% to below $3,550 per ounce, indicating a potential technical correction after recent highs [5] Entertainment Sector - The film and entertainment sector showed strength, with Orange Sky Golden Harvest rising over 7%. The summer box office exceeded 11.9 billion yuan, with over 320 million attendees, surpassing last year's figures [6] Coal Sector - Coal stocks were active, with Jiutai Bangda Energy up 4%. Analysts predict that coal prices have reached a low point, and profitability for coal companies is likely to rebound, with potential for price increases by year-end [7] Banking Sector - Banking stocks rose, with Agricultural Bank of China up over 2%. Other banks like China Everbright Bank, Bank of Communications, and Postal Savings Bank also saw gains [8] Individual Stock Movement - Zai Lab saw a significant drop of nearly 12%, closing at 23.04 HKD, with a total market capitalization of 25.75 billion HKD. Recent clinical trial results showed a reduction in previously observed survival benefits for a cancer treatment [9] Capital Flow - Southbound funds recorded a net inflow of 706 million HKD, with the Shanghai-Hong Kong Stock Connect seeing a net inflow of 1.386 billion HKD, while the Shenzhen-Hong Kong Stock Connect had a net outflow of 680 million HKD [10]

Core Insights - The final analysis of the FORTITUDE-101 Phase III clinical study for bemarituzumab combined with mFOLFOX6 in first-line gastric cancer treatment has been completed, showing a reduction in previously observed survival benefits compared to the interim analysis [1] Group 1: Clinical Study Results - The interim analysis indicated significant statistical and clinical improvement in overall survival for the bemarituzumab plus chemotherapy compared to chemotherapy alone [1] - The final analysis revealed a weakening of the survival benefit previously observed in the interim analysis [1] Group 2: Future Plans - The company plans to wait for the results of the FORTITUDE-102 study, which evaluates bemarituzumab combined with nivolumab and chemotherapy for the same patient population, before submitting a registration application [1] - Data from the FORTITUDE-102 study is expected to be available by the end of 2025 or the first half of 2026 [1]

Group 1 - The core point of the article is that the final analysis of the FORTITUDE-101 Phase III clinical study for bemarituzumab combined with chemotherapy (mFOLFOX6) in first-line gastric cancer treatment shows a reduction in previously observed survival benefits compared to the interim analysis [1] - The interim analysis indicated a statistically and clinically significant improvement in overall survival for the bemarituzumab combination therapy compared to chemotherapy alone [1] - The results from both the interim and final analyses will be presented at an upcoming major medical conference [1] Group 2 - The company plans to wait for the results of the FORTITUDE-102 study, which aims to evaluate bemarituzumab combined with nivolumab and chemotherapy for the same patient population, before submitting a registration application [1] - Data from the FORTITUDE-102 study is expected to be available by the end of 2025 or the first half of 2026 [1]

Core Viewpoint - The final analysis of the FORTITUDE-101 Phase III clinical study for Bemarituzumab combined with mFOLFOX6 in first-line gastric cancer treatment shows a reduction in previously observed survival benefits compared to the interim analysis [1] Group 1: Clinical Study Results - The interim analysis indicated significant statistical and clinical improvement in overall survival for the combination therapy compared to chemotherapy alone [1] - The final analysis revealed a weakening of the survival benefit previously observed in the interim analysis [1] Group 2: Future Plans - The company plans to wait for the results of the FORTITUDE-102 study, which evaluates Bemarituzumab combined with Nivolumab and chemotherapy for the same patient population, before submitting a registration application [1] - Data from the FORTITUDE-102 study is expected to be available by the end of 2025 or the first half of 2026 [1]