（来源：一度医药） 转自：一度医药 2025年9月25日，据外媒报道，海德堡制药（Heidelberg Pharma）近日宣布计划裁员75%。这一重大决 策的导火索，源于美国FDA对泰利克斯制药（Telix Pharmaceuticals）一款影像剂的驳回。 根据此前海德堡制药与Telix Pharmaceuticals签订的许可协议，如果TLX250-CDx获得市场批准，海德堡 制药有权获得里程碑付款和两位数的特许权使用费。为提前回笼资金，海德堡制药已将其未来特许权使 用费的一部分出售给HealthCare Royalty（HCRx），根据协议，公司将在TLX250-CDx获得FDA批准时 从HCRx获得7000万美元。 海德堡制药原本期待在2025年8月末，随着TLX250-CDX诊断试剂的获批，获得一笔7000万美元的付 款。然而，FDA的拒绝让这笔资金化为泡影，公司资金链陷入紧张。截至2025年年中，Heidelberg账上 仅有3300万欧元（约合3900万美元），原本的资金仅能维持到2026年第一季度。资金的短缺迫使公司不 得不采取紧急措施。 其中，HDP-101是一款新型的抗BCMA抗体药物偶联 ...

Core Insights - Hualing Pharmaceutical's drug Huatangning, the world's first glucose kinase activator (GKA) for diabetes, was approved in 2022, marking a significant milestone in China's biopharmaceutical industry [1][4] - Despite initial expectations, Huatangning's sales performance was underwhelming while partnered with Bayer, leading to a strategic shift to self-commercialization in 2025, resulting in a significant sales increase [1][8][15] - The drug's development faced challenges, with previous GKA candidates failing due to a lack of understanding of glucose kinase's role as a blood sugar sensor, which Hualing addressed by focusing on blood sugar variability rather than just lowering blood sugar levels [5][6][9] Company Performance - After taking back commercialization rights from Bayer, Hualing Pharmaceutical's sales team expanded significantly, achieving a 108% year-on-year increase in Huatangning's sales volume to 1.764 million boxes in the first half of 2025 [15] - The company reported a revenue of 2.174 billion yuan from Huatangning, with a net profit of 11.839 billion yuan, largely due to a one-time payment from terminating the agreement with Bayer [15][16] - Hualing's performance is part of a broader trend in the Chinese innovative drug sector, which saw a 7.26% revenue growth among 84 innovative drug companies in the first half of 2025 [15] Industry Trends - The Chinese innovative drug market is experiencing a surge, with domestic drugs accounting for 38% of global new drug approvals in 2024, expected to exceed 50% in 2025 [17] - The ongoing business development (BD) trend indicates a growing alignment between domestic biotech companies and international pharmaceutical firms, with a significant portion of FDA-approved drugs originating from biotech [17][18] - Future opportunities in the biotech sector are anticipated as new modalities like ADCs and bispecific antibodies emerge, suggesting that the market for innovative drugs will continue to expand [18]

Core Insights - Hualing Pharmaceutical's drug Huatangning, the world's first glucose kinase activator (GKA) for diabetes, was approved in 2022, marking a significant milestone in China's biopharmaceutical industry [2] - Despite initial expectations, Huatangning's sales performance was underwhelming while partnered with Bayer, leading to a strategic shift to self-commercialization in 2025, resulting in a sales volume increase of 108% in the first half of 2025 [2][14] - The company emphasizes the importance of glucose kinase's "glucose-dependence" in its drug development, aiming to stabilize blood sugar levels rather than merely lowering them [5][8] Company Development - Huatangning's development began in 1995, inspired by the discovery of glucose kinase, which regulates blood sugar levels [3][4] - The drug faced significant challenges, with over 20 candidates failing before Huatangning's success, attributed to a misunderstanding of glucose kinase's role [5] - The drug's clinical trials showed a low incidence of hypoglycemia, maintaining below 1% during trials and post-market surveillance [6] Commercial Strategy - Initially, Hualing partnered with Bayer for commercialization, which included a prepayment of 300 million yuan and potential milestone payments up to 4.18 billion yuan [7] - The partnership was seen as a model for collaboration between domestic biotech firms and multinational pharmaceutical companies, leveraging Bayer's market presence [7][12] - However, Bayer's internal restructuring and management inefficiencies hindered the drug's market performance, prompting Hualing to take over commercialization [12] Financial Performance - After taking back commercialization rights, Hualing's sales team expanded significantly, achieving a sales volume of 1.764 million boxes in the first half of 2025, with revenue reaching 217.4 million yuan [14] - The company reported a one-time income of 1.2435 billion yuan from terminating the agreement with Bayer, leading to a net profit of 1.1839 billion yuan, marking its first profitable quarter since going public [14] Industry Trends - The Chinese innovative drug market is experiencing rapid growth, with domestic drugs accounting for 38% of global new drug approvals in 2024, projected to exceed 50% [15][16] - The surge in interest in innovative drugs is linked to improved R&D efficiency and a growing trend of business development (BD) collaborations between biotech firms and multinational companies [15][16] - Future opportunities in the biotech sector are expected to arise from new modalities and technologies, indicating a continuous demand for innovative drug development [17]

Investment Rating - The report suggests a positive investment outlook for the small nucleic acid drug industry, highlighting its significant growth potential and advantages over traditional therapies [2]. Core Insights - The small nucleic acid drug technology is maturing, offering notable advantages such as shorter development cycles, a rich array of targets, lasting effects, and higher success rates in research and development [2]. - The global market for small nucleic acid drugs has grown from $2.7 billion in 2019 to $4.6 billion in 2023, with a compound annual growth rate (CAGR) of 14.3%. It is projected to reach $46.7 billion by 2033, growing at a CAGR of 26.1% from 2023 [2][41]. - Domestic companies are rapidly entering the market, focusing on chronic diseases rather than the traditional rare disease approach, with several products in clinical trials [2][63]. Summary by Sections 1. Introduction to Small Nucleic Acid Drugs - Small nucleic acid drugs include antisense oligonucleotides (ASO), small interfering RNA (siRNA), and aptamers, which are designed to target mRNA and regulate gene expression [8][12]. 2. Development and Commercialization of Small Nucleic Acid Drugs - The report outlines the historical development of small nucleic acid drugs, noting significant advancements post-2014 due to improved delivery systems [11][34]. - The market is currently dominated by ASO, which holds 62.5% of the market share, while siRNA has rapidly gained traction with a 36.7% share [18]. 3. Overview of Domestic and International Companies - Key domestic companies include Rebio, Shengnuo Pharmaceutical, and others, focusing on chronic diseases like cardiovascular issues and hepatitis B [2][63]. - International leaders such as Alnylam and Ionis are recognized for their pioneering work in the small nucleic acid drug space [2]. 4. Investment Analysis and Recommendations - The report recommends focusing on companies with proprietary technology platforms and advantageous pipelines, such as Rebio and Shengnuo Pharmaceutical [2].

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].

Core Viewpoint - 康乐卫士 has made significant progress in the application for the market approval of its trivalent HPV vaccine following the successful completion of the on-site inspection by the National Medical Products Administration [1] Group 1 - 康乐卫士 and its subsidiary, 康乐卫士 (昆明) 生物技术有限公司, received a notification from the National Medical Products Administration on July 23 regarding the on-site inspection for drug registration [1] - The company has recently passed the on-site inspection for its trivalent HPV vaccine, which is based on E. coli [1] - The successful completion of the registration inspection lays a solid foundation for the approval of the trivalent HPV vaccine for market launch [1]

天风证券研报指出，长春高新与ALK合作，有望开启中国脱敏新时代。本次合作产品包括ALK自主开 发的2款变应原特异性免疫治疗产品和1款用于过敏原诊断的皮肤点刺试剂盒。中国拥有全球尘螨过敏患 者最大的患者人群，但中国过敏免疫疗法市场开发不足、缺乏创新产品。目前接受脱敏治疗的患者数量 不足100万，存在大量未满足临床需求。认为此次合作有望与金赛的生长激素产品形成协同，横向拓展 公司产品线。维持"买入"评级。 ...

Group 1 - The company, Heptagon Pharmaceuticals-B (02142), announced a share buyback on September 25, 2025, spending HKD 1.4027 million to repurchase 100,000 shares [1] - The repurchase price per share ranged from HKD 13.99 to HKD 14.06 [1]

Core Viewpoint - Baili Tianheng (688506.SH) has announced that its self-developed first-in-class and new concept drug, iza-bren (EGFR×HER3 dual antibody ADC), has been included in the list of breakthrough therapies by the National Medical Products Administration's Drug Evaluation Center for patients with unresectable locally advanced or metastatic urothelial carcinoma who have failed platinum-based chemotherapy and PD-1/PD-L1 inhibitors [1] Group 1 - The drug iza-bren is the only one to have entered Phase III clinical trials in its category [1] - The inclusion in the breakthrough therapy list signifies a potential acceleration in the drug's development and approval process [1] - The announcement highlights the company's commitment to innovative cancer treatments [1]

Core Viewpoint - The company has announced that its self-developed drug, iza-bren, has been included in the list of breakthrough therapies by the National Medical Products Administration, marking a significant milestone in the treatment of advanced or metastatic urothelial carcinoma [1] Group 1 - The drug iza-bren is a first-in-class and new concept EGFR×HER3 dual antibody ADC [1] - It is specifically designed for patients with unresectable locally advanced or metastatic urothelial carcinoma who have failed previous platinum-based chemotherapy and PD-1/PD-L1 inhibitors [1] - The drug has successfully entered the Phase III clinical trial stage [1]