Investment Rating - The report maintains a "Buy" rating for the company, with a target price of 23.54 CNY based on a 22x P/E ratio for 2026 [5][12]. Core Insights - The company is in a rapid growth phase for its core business and key products over the next 1-2 years, with adjustments made to revenue and expense forecasts [5]. - The first innovative drug, Dazisin, has been approved and is expected to perform well commercially, with significant market potential in the insomnia treatment sector [12][42]. - The company has a strong pipeline focusing on central nervous system and lipid-lowering therapies, with promising products in various stages of development [12][22]. Financial Summary - Revenue projections for the company are as follows: - 2023: 3,999 million CNY - 2024: 4,159 million CNY (growth of 4.0%) - 2025: 4,279 million CNY (growth of 2.9%) - 2026: 4,714 million CNY (growth of 10.2%) - 2027: 5,363 million CNY (growth of 13.8%) [7]. - Net profit attributable to the parent company is projected to grow from 619 million CNY in 2023 to 1,079 million CNY in 2027, reflecting a compound annual growth rate of approximately 17.5% [7]. Business Focus - The company has shifted its focus towards innovation after facing challenges from centralized procurement, with a robust pipeline of generic and innovative drugs [12][15]. - The main therapeutic areas include central nervous system disorders, cardiovascular diseases, and digestive system conditions, with a strong emphasis on innovative drug development [15][19]. Product Pipeline - The company has a diverse pipeline with key products such as: - Dazisin (approved for insomnia) - JX11502 (in Phase II for schizophrenia) - JX2201 (in Phase I for high Lp(a) levels) [23][32]. - The company is also pursuing first-generic opportunities for high-value products, such as Calira, which has significant market potential [27][29]. Market Position - The company has established a solid market presence in the CNS and lipid-lowering sectors, with leading market shares in several key products [24][26]. - The innovative drug Dazisin is positioned to capture a significant share of the insomnia treatment market, which has over 200 million patients in China [42][45].

Core Insights - Guangdong Tianenkang Pharmaceutical Co., Ltd. has received a notice of acceptance from the National Medical Products Administration for its clinical trial application of CKBA ointment combined with narrowband ultraviolet B (NB-UVB) for treating non-segmental vitiligo in children aged 2 to 12 [1][2] - This marks a significant step for Tianenkang in the innovative treatment of pediatric vitiligo, potentially offering new hope for affected children and their families [1] - The CKBA ointment, a first-in-class immunomodulator targeting ACC1/MFE-2, demonstrates a unique mechanism of action by inhibiting the differentiation of CD8+ T cells and downregulating the expression of IFN-γ and IL-17, thereby improving the immune environment of the skin [1][2] Company Development - CKBA is recognized as the world's first drug targeting T cell fatty acid metabolism pathways, developed from natural products by a team from Shanghai Jiao Tong University, highlighting its innovative value and clinical potential [2] - The acceptance of the clinical trial application represents another important milestone in Tianenkang's journey of innovative drug development, reflecting the company's commitment to addressing unmet clinical needs and building a high-quality pipeline of innovative drugs [2] - Tianenkang aims to continue its focus on the pharmaceutical health sector, striving for more innovative outcomes to safeguard public health and create long-term value for investors [2]

Core Insights - Guangdong Taiankang Pharmaceutical Co., Ltd. has made significant progress in the innovative treatment of pediatric vitiligo with the acceptance of its clinical trial application for CKBA cream combined with narrowband ultraviolet B (NB-UVB) for children aged 2-12 [1][2] - The global prevalence of vitiligo, a chronic autoimmune disease characterized by skin pigment loss, is high, with children accounting for 32%-40% of cases, highlighting a substantial unmet clinical need in this demographic [1] Group 1 - The acceptance of the clinical trial application marks a key advancement for the company in the pediatric vitiligo treatment sector, potentially providing new options for affected children and their families [1] - Currently, there are no approved products for treating vitiligo in children globally, indicating a significant market opportunity for the company [1] - The company aims to address unmet clinical needs and enhance its innovative drug pipeline, reinforcing its commitment to public health and long-term value creation for investors [2] Group 2 - CKBA, a First-in-Class innovative drug with global intellectual property rights, is progressing steadily in its indication layout, with adult vitiligo in Phase II trials and plans for Phase III submission [2] - The company is also preparing for II/III phase trials for rosacea and advancing preclinical research for Alzheimer's disease, with an IND application planned for the second half of 2026 [2] - The acceptance of the pediatric vitiligo indication further enriches the company's indication matrix, showcasing its deep accumulation in innovative drug research and development [2]

Core Viewpoint - The Hong Kong stock market continues to adjust, with the Hang Seng Index showing mixed performance, while the innovative drug sector demonstrates resilience, as evidenced by the performance of the Hong Kong Stock Connect Innovative Drug ETF (520880) which ended a four-day decline [1][3]. Group 1: Market Performance - The Hong Kong Stock Connect Innovative Drug ETF (520880) saw a price increase of 1.79% during the day, successfully ending its previous four-day decline [1]. - The ETF's performance is supported by major leading stocks in the innovative drug sector, with notable gains from companies such as Innovent Biologics, which rose by 2.84%, and others like China Biologic Products and Kintor Pharmaceutical, which increased by over 1% [1]. Group 2: Investment Insights - Following a strong rebound of nearly 7% the previous week, the ETF has returned to a state of fluctuation, currently trading at a near four-month low, indicating a potential area for cost-effective investment [3]. - The fund manager, Feng Chen, suggests that each significant pullback in the innovative drug sector presents an opportunity for accumulation [3]. - The innovative drug sector is undergoing a notable correction since early September, attributed to market style shifts and the return to more realistic expectations regarding business development (BD) rhythms and amounts [3]. Group 3: ETF Characteristics - The Hong Kong Stock Connect Innovative Drug ETF (520880) is characterized by three unique advantages: it is purely focused on innovative drug companies, has a significant concentration of leading stocks with over 71% weight in the top ten holdings, and maintains better risk control by reducing the weight of less liquid component stocks [3][4]. - The top ten holdings in the ETF account for 71.51% of the total weight, showcasing the dominance of leading companies in the sector [4]. - As of November 19, the ETF has a scale of 2.12 billion HKD and an average daily trading volume of 464 million HKD since its inception, making it the largest and most liquid ETF tracking the same index [4].

Core Viewpoint - The company has received official inclusion of its innovative anti-PD-1 monoclonal antibody, Hanshuo (Sru Li Single Antibody Injection), in the breakthrough therapy drug program by the National Medical Products Administration (NMPA) for the neoadjuvant/adjuvant treatment of gastric cancer [1] Group 1 - Hanshuo has been approved for multiple indications in mainland China, including first-line treatment for squamous non-small cell lung cancer (sq-NSCLC), extensive small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC), and non-squamous non-small cell lung cancer (nsq-NSCLC) [1] - The drug has also received approvals in various countries/regions including the EU, UK, Indonesia, Cambodia, Thailand, Malaysia, Singapore, and India, and has been granted orphan drug designation by regulatory authorities in the US, EU, Switzerland, and South Korea [1] - The company is actively advancing multiple clinical trials for Hanshuo and related combination therapies globally, covering a wide range of indications including lung cancer, esophageal cancer, head and neck squamous cancer, colorectal cancer, and gastric cancer [1]

令人惊讶的是，这一估值背后是一个仅有47名员工的团队。截至2025年6月30日，公司研发相关人员 （药物发现与临床前开发+临床开发）共有31人，其余16人为一般与行政人员。在生物制药行业，这几 乎是一个"微型"团队。按估值计算，人均价值近4700万元。 然而，财务数据却呈现出另一番现实。 2023年7月，公司发生高管变更，财务负责人由潘家喆变更为王丽；2025年9月，公司财务负责人由王丽 变更为刘扬。王丽目前仍在公司实控人孝作祥控制的另一家企业——昊迈（杭州）企业管理咨询有限公 司中担任财务负责人，这家公司还是时迈药业的控股股东之一。但公司招股书中，并未披露王丽的离任 及履历情况。 在更早的2021年，公司还曾有另一位财务负责人。根据上市公司初灵信息（300250）2021年8月发布的 公告，严思恩是该公司的独立董事。在严思恩的简历中，初灵信息表示，严思恩现任公司独立董事、浙 江时迈药业有限公司CFO（首席财务官）、金华思来文化传媒有限公司经理、执行董事。 这也意味着，从2021年至2025年，时迈药业相继有严思恩、潘家喆、王丽和刘扬这四任财务负责人。 深圳报业集团旗下财中社在近日发布的报道《可能永远无法盈利 ...

Core Viewpoint - The company is advancing the development of WP103, an innovative drug targeting Hypoxic-Ischemic Encephalopathy (HIE) in newborns, which currently has no approved treatments globally [1] Group 1: Disease Significance and Market Potential - HIE is a serious neonatal brain injury caused by lack of oxygen and reduced blood flow, leading to high mortality rates and long-term neurological issues such as cerebral palsy and epilepsy, imposing a heavy burden on families and society [1] - The market for HIE treatments is vast, with hundreds of thousands of infants affected annually, and the market capacity is expected to reach $10 billion [1] Group 2: Drug Development Progress - WP103 has received both Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) from the FDA, indicating its innovative value and potential for 7 years of market exclusivity, priority review for new drug applications, and exemption from registration fees [1] - Recent large animal efficacy studies have shown WP103's promising therapeutic effects on key indicators, improving behavioral, neurological scores, and brain tissue pathology [1] - The company plans to communicate with the FDA to advance clinical research for HIE following the completion of preclinical studies [1] Group 3: Company Strategy and Expertise - The company has focused on HIE as a breakthrough area due to the lack of available treatments and urgent clinical needs, supported by a dedicated R&D team of approximately 120 members [1] - The company has established high-end platforms, including a postdoctoral workstation and an academician workstation, and has closely collaborated with the FDA to design non-clinical studies, which has been crucial for the rapid advancement of the project [1]

和誉 20251119 摘要 FGFR 4 项目目前进展如何？ FGFR 4 项目在研发日提供的数据和进展超出预期。目前二线加丹药的注册性 临床试验已于今年（2025 年）6 月开始患者入组，进展比原计划更快。预计明 年（2026 年）此时将完成试验并获得 ORR 数据，以便向 CDE 递交 NDA 申请。 这意味着 FGFR 4 可能在 2027 年四季度至 2028 年上半年进入商业化状态。 此外，一线加 Combo FURTHER 研究方案已与 FDA 初步沟通完毕，计划明年 上半年确定方案并开展全球多中心 MRCT 试验。 匹米替尼预计 2026 年下半年在中美欧实现商业化，有望带来可持续现 金流。美国市场销售峰值预计 5-6 亿美元，欧洲 4-5 亿欧元，中国 10- 15 亿人民币，加拿大和日本市场也将贡献增量。 FGFR 4 项目二线加丹药注册性临床试验提前至 2025 年 6 月启动患者 入组，预计 2026 年完成试验并获得 ORR 数据，有望 2027 年四季度至 2028 年上半年商业化。一线加 Combo FURTHER 研究方案已与 FDA 初步沟通，计划明年上半年开展全球多中心 M ...

Financial Performance - Revenue for 1-9/2025 was RMB 19,891 million, a decrease of 12.3% compared to RMB 22,686 million in 1-9/2024[27] - Gross profit for 1-9/2025 was RMB 13,049 million, down 18.4% from RMB 15,985 million in 1-9/2024[27] - Gross profit margin decreased by 4.9 percentage points, from 70.5% in 1-9/2024 to 65.6% in 1-9/2025[27] - R&D expenses increased by 7.9%, from RMB 3,880 million in 1-9/2024 to RMB 4,185 million in 1-9/2025[27] - Reported profit attributable to shareholders decreased by 7.1%, from RMB 3,778 million in 1-9/2024 to RMB 3,511 million in 1-9/2025[27] - Underlying profit attributable to shareholders decreased by 23.0%, from RMB 3,999 million in 1-9/2024 to RMB 3,079 million in 1-9/2025[27] - Finished drugs revenue decreased by 17.2%, from RMB 18,670 million to RMB 15,450 million[28] - Revenue from oncology decreased significantly by 56.8%, from RMB 3,809 million to RMB 1,645 million[29] - Revenue from nervous system decreased by 21.6%, from RMB 7,234 million to RMB 5,669 million[29] - License fee revenue was RMB 1,540 million in 1-9/2025, compared to no revenue in 1-9/2024[29] R&D and Regulatory Updates - 3 new drugs were approved[5] - 5 breakthrough therapy designations were received[5] - 12 new pivotal clinical trials were initiated[7] - 52 IND approvals were obtained, including 42 in China and 10 in North America[7] BD and Shareholder Returns - License-out agreements were made for SYS6005, Irinotecan Liposome Injection, SYH2086 and strategic collaboration with AstraZeneca[9, 115] - A total of HK$300 million worth of shares have been repurchased this year[8] - The 2025 interim dividend is HK14 cents per share[8] R&D Pipeline Highlights - Anbenitamab injection co docetaxel treatment of 1L HER2+ relapse/metastasis breast cancer was published in Cancer Communications, with ORR of 76.4% and mPFS of 27.7m[37] - SYS6091 for injection has been granted as BTD by NMPA for the treatment of platinum resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or whole population of patients with fallopian tube cancer and HER2-positive advanced colorectal cancer[45] - JMT101+ Irinotecan has been granted as BTD by NMPA for the treatment of RAS, RAF, EGFR ECD and PIK3CA exon 20 wild-type advanced colorectal cancer after failure of standard treatment in second-line or beyond[51] - The company has approximately 200 innovative drugs and new formulations[4, 96]

会上，白云山稀核健康与全球医疗科技巨头GE医疗签署战略合作协议，双方将致力在精准医疗与核医 学领域的发展与创新，为充分发挥白云山稀核健康在放射性药物研发、生产与管理专业优势，以及GE 医疗深厚的技术沉淀，推动医学影像前沿技术的提升及转化，共同引领核医学诊疗一体化的发展。此次 合作既是广药集团"科技化""国际化"战略的具体实践，也是跨界资源整合、推动产业升级的重要探索。 白云山稀核健康此次发布的完全自主知识产权医用放射性核素一体化解决方案，成功攻克固体靶系统与 分离纯化技术壁垒，构建了从辐照到核素制备的全链条技术体系；同步推出的镓-68、锆-89、铼-186与 铜-64四大核心医用核素，涵盖精准诊断、靶向治疗及诊疗一体化方向，标志着广药集团已能完全自 主、稳定地制备上述四种关键医用放射性核素以及在多核素药物研发平台的建设上取得了决定性突破。 中证报中证网讯（王珞）11月18日，2025年广药集团、广药白云山（600332）战略合作研讨会在南京举 办。大会汇聚合作伙伴、行业专家及企业代表等430余位嘉宾，搭建起覆盖医药大健康全产业链的高端 对话与资源对接平台，集中发布了广药集团创新战略、创新成果与合作规划，其中核 ...