机构：华创证券 研究员：郑辰/王宏雨 站在当前时点，公司在手项目数量稳步攀升，尤其是商业化验证前期关键环节的 PPQ（工艺验证）项 目持续增加，充分印证公司IND 后管线正加速向商业化阶段转化。随着公司逐步进入商业化项目收获 期，收入体量与利润规模有望实现中长期快速增长。 从ADC 到XDC，生物偶联药物行业高速发展。ADC 药物作为生物偶联药物中最主要的一类，以2024 年销售额计已出现6 款"重磅炸弹"药物；此外，以双抗ADC 和双载荷ADC 为代表的新型ADC 商业化在 即。据Frost & sullivan统计及预测，全球ADC 药物有望于2030 年达到662 亿美元。除了ADC，载体和有 效载荷还可以替换为其他形式的药物，并且有望拓展肿瘤以外的多种适应症，进一步拓宽应用场景。 同时，生物偶联药物开发复杂，高度依赖外包，产业链有望充分受益。据Frost& sullivan 和公司分析， 未来ADC 药物的外包率有望维持在较高水平（~60%），同时格局相对集中，结合公司分析，2025 年药 明合联在全球ADC 外包市场市占率已达到24+%。 药明合联前瞻投入资本开支，生物偶联CRDMO 龙头扬帆起航。 ...

Investment Rating - The report assigns a "Buy" rating for the company, marking its first coverage [1]. Core Insights - The company is entering a new drug approval harvest period with a well-structured pipeline covering ADC (Antibody-Drug Conjugates) and IO (Immuno-Oncology) [3][10]. - The company has multiple oncology product pipelines, including immune therapy, ADC targeted therapy, and oncolytic virus drugs, with several candidates in clinical stages [3][11]. - The company achieved its first profitability and positive operating cash flow in the first half of 2025, driven by business development and sales [3][25]. Summary by Sections R&D Coverage and Pipeline - The company focuses on oncology treatment, establishing a comprehensive ADC technology platform and has developed multiple ADC products, including PD-1 monoclonal antibody and MRG003 [11][14]. - The pipeline includes six ADC drugs, one oncolytic virus, and one TCE (T-cell Engager) drug in clinical stages, with several candidates entering pivotal trials [14][18]. Unique Features of ADC Candidates - MRG003 (EGFR ADC) has been approved for NPC (Nasopharyngeal Carcinoma) in China, showing superior survival benefits and safety compared to competitors [4][30]. - MRG004A (TF-ADC) is in Phase III trials for pancreatic cancer, while MRG006A (GPC3 ADC) targets the liver cancer market and is expected to enter Phase III trials in 2026 [6][30]. Oncolytic Virus and International Expansion - The company introduced the oncolytic virus therapy CG0070, which is in critical registration trials in China and has shown promising efficacy in the U.S. for bladder cancer [5][30]. - The company has successfully partnered for international expansion with MRG007 (CDH17 ADC) and CTM012 (CD3/4-1BB/DLL3 tri-antibody) [5][30]. Financial Projections and Investment Recommendations - Revenue projections for 2025, 2026, and 2027 are estimated at 880 million, 1.02 billion, and 1.49 billion yuan, respectively, with expected growth rates of 138%, 16%, and 47% [6][30]. - The company is still in the investment phase for innovative drug development, with projected net profits of -20 million, 10 million, and 280 million yuan for the same years [6][30].

Investment Rating - The report assigns a "Buy" rating for the company, Lepu Biopharma (2157.HK), marking its first coverage [1]. Core Insights - The company is entering a harvest period for new drug approvals, having established a comprehensive pipeline in oncology that includes immunotherapy, ADC (Antibody-Drug Conjugate) targeted therapy, and oncolytic virus drugs. The company has multiple ADC drugs and other therapies in clinical stages, with expectations for new drug approvals in the next 3-5 years [3][10]. - The ADC pipeline is characterized by unique features and competitive advantages in various indications, with MRG003 (EGFR ADC) already approved for NPC (nasopharyngeal carcinoma) in China and showing promising results in other indications [4][30]. - The introduction of oncolytic virus therapy CG0070 has shown potential in the bladder cancer market, with successful regulatory progress in the U.S. and ongoing clinical trials in China [5][30]. - Financially, the company has achieved its first profit and positive operating cash flow in the first half of 2025, with steady revenue growth driven by business development and sales [25]. Summary by Sections R&D Coverage and Pipeline - The company focuses on oncology treatment, with a pipeline that includes immunotherapy, ADCs, and oncolytic virus therapies. It has developed a robust ADC technology platform and has multiple products in various stages of clinical development [11][10]. - The pipeline includes 6 ADC drugs and 1 oncolytic virus therapy, with several candidates in pivotal clinical stages, indicating a well-structured development strategy [14][10]. Unique Features of ADCs - MRG003 has been approved for NPC and is in advanced trials for HNSCC (head and neck squamous cell carcinoma) and NSCLC (non-small cell lung cancer), showcasing its broad applicability and competitive edge [30][4]. - Other ADCs in development, such as MRG004A for pancreatic cancer and MRG006A for liver cancer, are also progressing well, with MRG004A entering pivotal trials [30][6]. Financial Performance and Projections - The company reported revenues of 4.66 billion yuan in the first half of 2025, a significant increase from 1.33 billion yuan in the same period of 2024. The net profit for the same period was 290 million yuan, marking a turnaround from a loss of 197 million yuan in the previous year [25][30]. - Revenue projections for 2025, 2026, and 2027 are estimated at 8.8 billion yuan, 10.2 billion yuan, and 14.9 billion yuan, respectively, with expected growth rates of 138%, 16%, and 47% [30].

Core Viewpoint - The stock of Immune-Oncological Biotech (09606) has risen over 6%, currently trading at 340.6 HKD, with a transaction volume of 154 million HKD, following the announcement of BioNTech initiating the first Phase III clinical trial for BNT324 (DB-1311), a B7-H3ADC drug developed by Immune-Oncological Biotech [1] Group 1 - BioNTech has started the first Phase III clinical trial for BNT324, marking it as the fifth B7-H3ADC to enter this stage [1] - BNT324 was licensed to BioNTech in April 2023, granting them development, production, and commercialization rights outside of China [1] - Guotai Junan Securities predicts that by 2026, multiple clinical data sets for ADC+IO and core monotherapy will be released, indicating a significant milestone for Immune-Oncological Biotech [1] Group 2 - Immune-Oncological Biotech is leading the ADC iteration wave, with expectations for commercialization in 2026 [1] - The company is continuously developing next-generation ADCs, including bispecific ADCs, novel mechanism payload ADCs, and self-immune ADCs [1] - Two bispecific ADCs have already entered clinical stages, and the unique MOA payload ADC DB-1316 is expected to address existing ADC resistance issues and is about to enter clinical trials [1]

Core Viewpoint - The stock of InnoCare Pharma (09606) has risen over 6%, currently trading at 340.6 HKD, with a transaction volume of 154 million HKD, following the announcement of BioNTech initiating the first Phase III clinical trial for BNT324 (DB-1311), a B7-H3 ADC developed by InnoCare [1] Group 1: Clinical Development - BioNTech has started the first Phase III clinical trial for BNT324, marking it as the fifth B7-H3 ADC to enter this stage [1] - InnoCare has licensed BNT324 to BioNTech, which holds the rights for development, production, and commercialization outside of China [1] Group 2: Future Prospects - Guolian Minsheng Securities predicts that by 2026, multiple clinical data for ADC+IO and core monotherapy will be released, with InnoCare's collaboration with BioNTech expected to lead to significant developments [1] - InnoCare is at the forefront of the ADC evolution, with expectations for commercialization in 2026 [1] - The company is actively developing next-generation ADCs, including bispecific ADCs, novel mechanism payload ADCs, and immune ADCs, with two bispecific ADCs already in clinical stages [1] - The unique MOA payload ADC DB-1316 is anticipated to address existing ADC resistance issues and is set to enter clinical stages soon [1]

Core Insights - The company announced that its self-developed ADAM9 ADC drug DB-1317 has received IND approval from the NMPA to conduct clinical trials in patients with advanced/metastatic malignant solid tumors [1] - DB-1317 targets ADAM9, which is highly expressed in various cancers such as gastric, colorectal, pancreatic, and non-small cell lung cancer, while showing low expression in normal tissues [1] - The company is leading the ADC innovation wave and expects significant commercialization opportunities in 2026, with multiple clinical data readouts scheduled for that year [2] Clinical Development - The company is collaborating with BioNtech to develop three ADC pipelines, with multiple clinical data readouts expected in 2026, including HER2 ADC in breast cancer and B7H3 ADC in non-small cell lung cancer [2] - The HER2 ADC DB-1303 has reached its primary endpoint in a Phase III trial for HER2-positive unresectable or metastatic breast cancer, accelerating its market approval process [3] - The company anticipates that 2026 will be a pivotal year for commercialization, with potential approvals for multiple indications [3] Financial Projections - Revenue projections for the company are estimated at 1.95 billion, 1.97 billion, and 2.1 billion yuan for 2025-2027, with year-on-year growth rates of 0.5%, 1.1%, and 6.5% respectively [3] - The net profit attributable to the parent company is projected to be -247 million, -386 million, and -341 million yuan for the same period, with growth rates of 76.5%, -56.1%, and 11.5% respectively [3] - The company has initiated coverage with a "recommended" rating based on its growth potential and upcoming clinical data [3]

Investment Rating - The report assigns a "Buy" rating for the company, indicating a positive outlook for its stock performance [5]. Core Insights - The company is leading the ADC (Antibody-Drug Conjugate) iteration wave and is expected to achieve commercialization by 2026 [2][3]. - The company has received IND approval for its self-developed ADAM9 ADC drug DB-1317, allowing clinical trials in late-stage metastatic solid tumor patients [2]. - The HER2 ADC DB-1303 has reached its primary endpoint in a Phase III clinical trial for HER2-positive unresectable or metastatic breast cancer, accelerating its path to market [3]. - The company is expected to report significant clinical data in 2026, which could enhance its market position and revenue potential [9]. Financial Forecasts - Projected revenues for the company are as follows: 1,941 million RMB in 2024, 1,950 million RMB in 2025, 1,972 million RMB in 2026, and 2,100 million RMB in 2027, with growth rates of 8.7%, 0.5%, 1.1%, and 6.5% respectively [4]. - The net profit attributable to shareholders is forecasted to be -1,050 million RMB in 2024, -247 million RMB in 2025, -386 million RMB in 2026, and -341 million RMB in 2027, showing a significant improvement in 2025 with a growth rate of 76.5% [4]. - Earnings per share (EPS) are expected to be -11.75 RMB in 2024, -2.76 RMB in 2025, -4.31 RMB in 2026, and -3.82 RMB in 2027 [4].

Investment Rating - The report assigns a "Buy" rating for the company, indicating a positive outlook for its stock performance [5]. Core Insights - The company is leading the ADC (Antibody-Drug Conjugate) innovation wave and is expected to achieve commercialization by 2026 [2][3]. - The company has received IND approval for its self-developed ADAM9 ADC drug DB-1317, allowing clinical trials in late-stage metastatic solid tumor patients [2]. - The HER2 ADC DB-1303 has reached its primary endpoint in a Phase III clinical trial for HER2-positive unresectable or metastatic breast cancer, accelerating its market approval process [3]. - The company is expected to report multiple clinical data readouts in 2026, which could significantly impact its growth trajectory [9]. Financial Forecasts - Projected revenues for 2024, 2025, 2026, and 2027 are 1,941 million, 1,950 million, 1,972 million, and 2,100 million RMB respectively, with growth rates of 8.7%, 0.5%, 1.1%, and 6.5% [4]. - The net profit attributable to shareholders is forecasted to be -1,050 million, -247 million, -386 million, and -341 million RMB for the same years, reflecting growth rates of -193.8%, 76.5%, -56.1%, and 11.5% [4]. - Earnings per share (EPS) are expected to be -11.75, -2.76, -4.31, and -3.82 RMB for 2024, 2025, 2026, and 2027 respectively [4]. Clinical Development and Pipeline - The company is advancing its ADC pipeline, including DB-1316, which aims to address existing ADC resistance issues and is set to enter clinical stages soon [9]. - Collaborations with BioNtech are expected to yield significant clinical data in 2026, enhancing the company's competitive position in the ADC market [9].

Core Insights - Rongchang Biopharmaceutical has authorized all overseas rights of its PD-1/VEGF dual antibody RC148 to AbbVie, with an upfront payment of $650 million, potentially reaching a total of $5.6 billion, approximately 4 billion RMB [3][21][28] - The transaction marks a significant turnaround for Rongchang Biopharmaceutical, which had faced skepticism regarding its aggressive strategy due to slow commercialization and substantial losses in recent years [5][22][28] Company Overview - Founded in 2008 by Wang Weidong and Harvard-returned scientist Fang Jianmin, Rongchang Biopharmaceutical is one of the early innovators in China's pharmaceutical industry, focusing on ADC (antibody-drug conjugate) products [3][21] - The company has a total market capitalization exceeding 100 billion RMB across its A and H shares [21] Financial Impact - The $650 million upfront payment from AbbVie is nearly three times Rongchang Biopharmaceutical's revenue for the first three quarters of the previous year [20][28] - This deal injects substantial funds into the company, which had reported losses exceeding 500 million RMB and had only 1.07 billion RMB in cash reserves as of the third quarter of last year [5][22] Market Position and Strategy - Rongchang Biopharmaceutical has historically adopted a "high-risk, high-reward" strategy, with a large sales team and extensive R&D pipeline [4][22] - The company has been proactive in signaling potential new business development (BD) deals, although it took until 2025 to confirm two significant collaborations [24][28] Product Development - RC148 is the first product from Rongchang's dual antibody platform to enter clinical trials, focusing on solid tumors [10][27] - The clinical data for RC148 shows promising results, with objective response rates of 61.9% for monotherapy and 66.7% when combined with chemotherapy, indicating potential to surpass standard treatments [31] Competitive Landscape - The competition in the PD-1/VEGF dual antibody market is intensifying, with other companies like Kangfang Biopharmaceutical and Sanofi entering advanced clinical stages [29][31] - The ability to conduct global clinical trials and explore multiple indications is becoming a key competitive factor in this space [30][31]

Group 1 - The core point of the news is the acquisition of Easton Pharmaceuticals by WuXi AppTec, which aims to strengthen its position in the ADC (Antibody-Drug Conjugate) sector by acquiring a CDMO (Contract Development and Manufacturing Organization) company at a significant premium of approximately 99% over the market price [1][2] - The acquisition is valued at around HKD 3.1 billion, with WuXi AppTec offering HKD 4 per share for Easton Pharmaceuticals, which has a market capitalization of HKD 31.68 billion post-announcement [1][2] - Following the acquisition announcement, Easton Pharmaceuticals' stock surged by 64%, while WuXi AppTec's stock initially rose but later fell by 3.04% [1] Group 2 - The ADC market has seen substantial growth, with a compound annual growth rate (CAGR) of 38.6%, increasing from USD 2 billion in 2018 to USD 10.4 billion in 2023, and is projected to continue expanding with 21 ADC drugs expected to be approved by the end of 2025 [4] - WuXi AppTec, established in May 2021, is uniquely positioned in the industry as it holds capabilities in small molecule toxins, linkers, and antibody biologics, making it a comprehensive player in the ADC space [4][5] - Easton Pharmaceuticals, originally a biotech company focused on ADC drug development, has shifted its strategy to become a full-fledged ADC CDMO after terminating its TAA013 project due to competitive pressures from similar products [5][6] Group 3 - Easton Pharmaceuticals has faced challenges in its revenue contributions from its CDMO business, with product sales accounting for 80% of its revenue, and a decline in both product sales and CDMO/CMO business revenue reported for the first half of 2025 [6] - WuXi AppTec has been actively expanding its production capacity, with a global dual-plant strategy and a recent completion of a USD 350 million refinancing to support this expansion [7][9] - The acquisition is seen as a potential turning point for the industry, reflecting a trend of consolidation and capacity expansion among key players in the ADC market [9]