Core Insights - Heng Rui Medicine's SHR-A1904 has been included in the list of breakthrough therapies by the National Medical Products Administration, marking a significant advancement in the ADC field [1] - The global ADC market is experiencing explosive growth, with the market size surpassing $10 billion in 2023 and projected to reach $66.2 billion by 2030 [4] Group 1: Company Developments - Heng Rui Medicine's SHR-A1904 is a targeted Claudin18.2 antibody-drug conjugate (ADC) with a payload of topoisomerase inhibitor, currently undergoing multiple clinical studies for various solid tumors [1] - The company has invested approximately 174 million yuan in the development of SHR-A1904 [1] - Heng Rui Medicine's SHR-A2102, another ADC targeting Nectin-4, has received clinical trial approval, with a total investment of about 248 million yuan in its development [2] - The company has established a proprietary technology platform for ADCs, with over 10 differentiated ADC molecules successfully approved for clinical trials [2] Group 2: Industry Trends - Other innovative pharmaceutical companies, such as CanSino Biologics, BaiLi TianHeng, and Kelun-Biotech, are also making significant progress in ADC development [3] - The ADC drug market is characterized by rapid innovation and increasing recognition of the value of Chinese ADC assets in international markets [4] - Strategic partnerships, such as the one between Kelun-Biotech and Crescent Biopharma, highlight the growing trend of Chinese ADC companies expanding their reach globally [4]

Core Viewpoint - Heng Rui Medicine's SHR-A1904 has been included in the list of breakthrough therapeutic varieties by the National Medical Products Administration, marking a significant advancement in the ADC (antibody-drug conjugate) sector, which is expected to grow substantially in the oncology treatment market [1][2]. Group 1: Company Developments - SHR-A1904 is a targeted Claudin18.2 antibody-drug conjugate developed by Heng Rui Medicine, with a cumulative R&D investment of approximately 174 million yuan [2]. - The company has also received approval for clinical trials of SHR-A2102, another ADC targeting Nectin-4, with a cumulative R&D investment of about 248 million yuan [2]. - Heng Rui Medicine has established a proprietary technology platform for ADCs, with over 5,000 patients across 15 tumor types validated globally, and more than 10 differentiated ADC molecules successfully approved for clinical use [3]. Group 2: Industry Trends - The ADC drug market is experiencing explosive growth, with the global market size surpassing $10 billion in 2023 and projected to reach $66.2 billion by 2030, according to Frost & Sullivan [6]. - Other innovative pharmaceutical companies, such as Cangzhou Jianan, Bai Li Tianheng, and Ke Lun Bo Tai, are also making significant advancements in ADC development, indicating a competitive landscape in the sector [4]. - Chinese companies are becoming key players in global ADC innovation, with increasing recognition of the value of Chinese ADC assets in international collaborations [6].

2025年，在"双循环"新发展格局下，中国资本市场正经历一场深刻的蜕变。全球资本再平衡的浪潮中，中国逐渐成为那个不可忽视的核心锚点。 而在这一宏大叙事中，创新药板块无疑是今年最为亮眼的主角之一。行业从过去的"数量追逐"大步迈向"硬科技决胜"，资本市场也以真金白银投票：板块整 体走强，细分赛道黑马频出。 其中，康宁杰瑞在2025年不仅完成蜕变，在资本市场获得认可，年内股价涨幅220.57%(数据截止2025年12月22日收盘)，成为中大型未盈利生物科技公司中 的领跑者，更在近期荣获由格隆汇颁布的"年度创新力奖"，这一奖项背后，是对其"以平台化技术为引擎，实现管线高效、快速产出"创新模式的权威肯定。 那么，在创新药走向硬科技之路下，为什么康宁杰瑞能够脱颖而出?背后的底层逻辑是什么? 2025年，创新药板块走出了一轮清晰的结构性牛市。在估值修复、政策支持与BD出海浪潮的多重推动下，整个行业的估值体系正在被系统性重构。 资本市场的共识已然明确：创新药的投资逻辑，已从早先的"故事与管线"叙事，转向对"商业化兑现能力"与"持续创新动能"的深度定价。政策鼓励源头创 新、审评审批持续提速、头部药企海外授权(BD)高频落地：这 ...

智通财经APP获悉，国金证券发布研报称，预测2025/2026/2027年康宁杰瑞制药-B(09966)营业收入 4.43/4.86/5.50亿元，同比-30.87%/+9.78%/+13.22%，归母净利润-1.05/-0.98/-0.24亿元，同 比-162.91%/+6.62%/+75.61%。采用DCF估值法，给予目标价14.30港元/股，首次覆盖，给予"买入"评 级。 JSKN003为公司自研HER2双抗ADC，该产品针对多适应症的III期临床试验在中国有序推进：在铂类耐 药卵巢癌全人群适应症中，其疗效与安全性已展现出优于Enhertu的特征，预计2027年完成数据读出并 报产;预计2026年向CDE提交2L HER2阳性乳腺癌的NDA;2025年10月启动中国HER2阳性转移性结直肠 癌适应症III期临床，该行预期JSKN003预期27/28/29年销售分成为0.05/0.57/1.08亿元。 差异化靶点布局与自研偶联平台双轮驱动，存在BD机遇 公司依托自有糖基化定点偶联核心技术平台，结合差异化靶点布局策略，构筑了多元化双抗ADC产品 矩阵：其中JSKN016为全球首个TROP2/HER3双抗AD ...

风险提示：临床试验进展不及预期;新药研发结果不及预期;市场推广及销售不及预期 JSKN003凭借技术创新构筑差异化竞争优势 JSKN003为公司自研HER2双抗ADC，该产品针对多适应症的III期临床试验在中国有序推进：在铂类耐 药卵巢癌全人群适应症中，其疗效与安全性已展现出优于Enhertu的特征，预计2027年完成数据读出并 报产;预计2026年向CDE提交2L HER2阳性乳腺癌的NDA;2025年10月启动中国HER2阳性转移性结直肠 癌适应症III期临床，该行预期JSKN003预期27/28/29年销售分成为0.05/0.57/1.08亿元。 差异化靶点布局与自研偶联平台双轮驱动，存在BD机遇 公司依托自有糖基化定点偶联核心技术平台，结合差异化靶点布局策略，构筑了多元化双抗ADC产品 矩阵：其中JSKN016为全球首个TROP2/HER3双抗ADC，已在肺癌、乳腺癌等适应症入组超400例患 者，市场潜在空间广阔;JSKN022作为全球FIC靶向PD-L1/ITGB6双抗ADC于十月启动首例患者给药， JSKN027为具备细胞毒性杀伤、抗血管生成及免疫调节三重作用机制的全球FIC双抗ADC，有望近期申 ...

Investment Rating - The report gives a "Buy" rating for the company, marking its first coverage [1]. Core Views - The company is moving towards a harvest period with multiple licensing collaborations validating its platform value [1]. - The company achieved its first profit in 2024, driven by significant licensing income and a strong focus on R&D [6][22]. - The company has a robust pipeline of HER2-targeted products, with key candidates in late-stage clinical trials [6][25]. Summary by Sections 1. Technical Innovation as a Driver - The company focuses on antibody-drug conjugates (ADC) and bispecific antibodies, leveraging core technologies for differentiated cancer immunotherapy [11]. - The management team has extensive experience in research and development, ensuring innovation and operational efficiency [11][19]. - The company has secured multiple high-value licensing agreements, enhancing its platform and pipeline value [19][20]. 2. HER2-targeted Product Strategy - The company has three HER2-targeted products, including KN026 (HER2 bispecific antibody) and JSKN003 (HER2 bispecific ADC), positioned for various cancer indications [25][30]. - KN026 is expected to submit a domestic application for 2L+ HER2-positive gastric cancer by 2025, with promising clinical data [30][34]. - JSKN003 has a commercial collaboration with a partner, with a total transaction value of 30.8 billion RMB [39]. 3. JSKN016 (TROP2/HER3 ADC) Development - JSKN016 is being explored for both monotherapy and combination treatments, targeting high-expression TROP2 and HER3 in various tumors [7][25]. - The drug is in clinical phase 2, focusing on unmet needs in triple-negative breast cancer and EGFR-TKI resistant non-small cell lung cancer [7][25]. 4. Financial Performance and Projections - The company achieved a revenue of 6.4 billion RMB in 2024, a year-on-year increase of 192.6%, with a profit of 1.66 billion RMB [22][23]. - The R&D expenditure for 2024 was maintained at 4.04 billion RMB, ensuring continued investment in clinical development [22][24]. - Revenue projections for 2025-2027 are estimated at 4.58 billion RMB, 4.90 billion RMB, and 3.98 billion RMB respectively [6][25].

Investment Rating - The report maintains a "Buy" rating for multiple companies in the pharmaceutical and biotech industry, indicating a positive outlook on their growth potential and market performance [6]. Core Insights - The ASCO conference showcased significant advancements in domestic innovative drugs, highlighting the competitive edge of Chinese pharmaceutical companies in the global market [4][12]. - The report emphasizes the clinical value and market potential of several key drugs presented at ASCO, including promising results from various companies [4][12]. Summary by Relevant Sections Domestic Key Research Overview - BaiLi Tianheng's BL-B01D1 demonstrated a 35.3% confirmed overall response rate (cORR) in patients with non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) [18]. - DiZhe Pharmaceutical's DZD6008 achieved over 80% overall response rate (ORR) in heavily treated chronic lymphocytic leukemia (CLL) patients, indicating its potential as a new treatment option [4][12]. - FuHong HanLin's PD-L1 ADC showed excellent performance in immune-resistant squamous NSCLC patients, while HLX22 is expected to redefine first-line treatment for advanced gastric cancer [4][12]. - KeLun BoTai's sac-TMT data confirmed long-term survival benefits in third-line EGFR-mutant NSCLC and first-line triple-negative breast cancer (TNBC) [4][12]. - KangNing JieRui's HER2 bispecific ADC demonstrated comparable efficacy and better safety than existing treatments [4][12]. - MaiWei Biotech's 9MW2821 combined with toripalimab is anticipated to be a strong contender in first-line urothelial carcinoma treatment [4][12]. - SanSheng Pharmaceutical updated data on SSGJ-707 for first-line treatment of wild-type NSCLC, with a significant partnership with Pfizer [4][12]. - XinDa Biotech's IBI363 showed potential in activating "cold" tumors, aiming to become a cornerstone drug in immunotherapy [4][12]. - YaSheng Pharmaceutical's Lisaftoclax achieved positive results in patients resistant to venetoclax, filling a treatment gap in myeloid malignancies [4][12]. - ZhengDa TianQing's "DeFu combination" was selected for LBA, potentially offering a new first-line treatment for PD-L1 positive NSCLC [4][12]. - ZeJing Pharmaceutical and ZaiDing Pharmaceutical presented excellent data on ZG006 and ZL-1310 for late-line SCLC treatment, showcasing the global competitiveness of domestic drugs [4][12].

Group 1 - The core viewpoint of the report is that Guangfa Securities is optimistic about the differentiated biopharmaceutical platform of CStone Pharmaceuticals-B (09966) and the development potential of its ADC drugs, which have shown preliminary clinical efficacy [1] - The company was established in 2015 and focuses on the development, production, and commercialization of innovative anti-tumor biologics, with a highly differentiated internal pipeline covering anti-tumor drugs at various research stages [1] - The first product, KN035 (Envafolimab injection), was launched in November 2021, marking the company's entry into the commercialization phase [1] Group 2 - CStone Pharmaceuticals has developed several globally leading biopharmaceutical technology platforms, including glycoengineered conjugation platform, linker payload platform, bispecific antibody platform, and subcutaneous high-concentration formulation platform, which have differentiated therapeutic advantages [1] - The glycoengineered conjugation platform reduces the production cost of ADC drugs while effectively minimizing toxin release in the circulatory system, enhancing drug safety [1] - Products developed based on this platform, JSKN003 and JSKN016, have entered clinical stages, and the company has upgraded the dual payload technology platform with corresponding products expected to enter clinical trials [1] Group 3 - The HER2 bispecific antibody KN026 is undergoing registration clinical studies for second-line gastric cancer, first-line breast cancer, and neoadjuvant therapy, with a promising path to market [2] - The HER2 bispecific ADC JSKN003 is in phase III clinical trials for breast cancer and platinum-resistant ovarian cancer, demonstrating competitive efficacy in early clinical studies [2] - The HER3/TROP2 bispecific ADC JSKN016 has initiated clinical trials for lung cancer and breast cancer, indicating a broad potential market, while new generation ADCs like JSKN021 (dual payload) and JSKN022 are expected to advance to clinical stages quickly [2]