Science Drives INNOVATION For the Benefit of Patients 中期報告 股份代號：9969 （於開曼群島註冊成立的有限公司） 2025 中期報告 科學驅動創新患者所需為本 InnoCare Pharma Limited 諾誠健華醫藥有限公司 InnoCare Pharma Limited 2025 諾誠健華醫藥有限公司 目錄 諾誠健華醫藥有限公司 2025年中期報告 | 技術詞彙及釋義 | 2 | | --- | --- | | 公司資料 | 7 | | 業務摘要 | 8 | | 財務摘要 | 15 | | 管理層討論及分析 | 17 | | 企業管治及其他資料 | 51 | | 獨立審閱報告 | 75 | | 中期簡明綜合損益表 | 76 | | 中期簡明綜合全面收益表 | 77 | | 中期簡明綜合財務狀況表 | 78 | | 中期簡明綜合權益變動表 | 80 | | 中期簡明綜合現金流量表 | 82 | | 中期簡明綜合財務資料附註 | 84 | 技術詞彙及釋義 在本報告內，除文義另有所指外，以下詞彙具有下列涵義。該等詞彙及其定義未必與任何業內標準定義 相符 ...

Group 1 - The Hang Seng Index declined by 0.32% and the Hang Seng Tech Index fell by 0.68% [1] - Kuaishou experienced a drop of over 6% [1] - Pharmaceutical stocks showed strength, with Nuo Cheng Jian Hua rising by over 3% [1]

Group 1 - The pharmaceutical stocks have generally risen, with notable increases in companies such as WuXi AppTec (6.82% increase), Innovent Biologics (5.72% increase), and WuXi Biologics (3.86% increase) [1] - The National Healthcare Security Administration has released the 11th batch of centralized procurement documents for drugs, emphasizing principles such as "stabilizing clinical use, ensuring quality, preventing collusion, and countering internal competition" [1] - The optimization of price control benchmarks in the procurement process indicates a shift away from simply selecting the lowest bid, reflecting a proactive approach by the healthcare authority to improve the domestic market [1] Group 2 - Guojin Securities expresses strong confidence in a reversal trend for the pharmaceutical sector in 2025, highlighting innovative drugs and the recovery of left-behind sectors as significant investment opportunities [2] - The upward trend in the innovative drug industry remains intact, with multinational corporations facing patent cliffs and likely to continue using business development strategies to fill revenue gaps [2] - Dongwu Securities notes that the easing interest rate environment is expected to enhance the prosperity of the innovative industry chain, benefiting upstream biotech and CXO sectors [2]

每经AI快讯，9月22日，港股医药股多数上扬。截至发稿，药明合联(02268.HK)涨6.82%，报75.2港元； 诺诚健华(09969.HK)涨5.72%，报17.38港元；药明生物(02269.HK)涨3.86%，报39.24港元；歌礼制药- B(01672.HK)涨3.09%，报11.01港元；恒瑞医药(01276.HK)涨2.74%，报90港元。 ...

Investment Rating - The report indicates a positive outlook for the atopic dermatitis (AD) market, highlighting significant unmet medical needs and potential for new therapies, particularly in small molecules and biologics [4][10][12]. Core Insights - Atopic dermatitis is a chronic, recurrent inflammatory skin disease characterized by severe itching, affecting approximately 600-700 million patients globally, with around 67 million in China, indicating a substantial unmet demand for effective treatments [1][18][20]. - Recent advancements in small molecules and biologics have marked a new phase in AD treatment, with several new products entering the market, although the number remains limited [1][10][32]. - JAK inhibitors have shown excellent efficacy but come with safety concerns, while TYK2 inhibitors are emerging as a promising new option due to their selective action and potentially better safety profile [2][11][12]. - Biologics targeting IL-4Rα and IL-13 have demonstrated significant efficacy in improving skin lesions, with IL-31 showing strong itch relief capabilities [3][12][13]. - The development of dual/multi-target antibodies is seen as a new strategy to enhance treatment efficacy by combining the advantages of different targets [4][13][21]. Summary by Sections Investment Highlights - The AD market has immense potential, with a pressing need for effective therapies [4][10]. - The patient population is large, with over 600 million affected globally, necessitating urgent treatment options [1][18]. Disease Characteristics - AD is characterized by chronic inflammation and severe itching, significantly impacting patients' daily lives [1][14]. - The disease burden is heavy, with a complex pathogenesis involving multiple factors, primarily driven by Th2-type inflammation [21][24]. Current Treatment Landscape - Traditional therapies have safety concerns, leading to a shift towards biologics and small molecules [32][35]. - JAK inhibitors are the most approved class of drugs for AD, but they carry black box warnings due to safety issues [11][12]. - Emerging therapies, particularly TYK2 inhibitors, show promise for better safety and efficacy [2][11]. Biologics and Emerging Therapies - Currently approved biologics include IL-4Rα, IL-13, TSLP, and IL-31, with ongoing research into additional targets [3][12][13]. - Dual/multi-target antibodies are being explored to improve treatment outcomes and extend dosing intervals [4][13][21]. Market Potential - The report emphasizes the significant market potential for AD treatments, with projected growth driven by increasing patient numbers and the introduction of innovative therapies [4][10][20].

Core Insights - Lymphoma is the 10th most common cancer globally and has a rapidly increasing incidence rate, with approximately 100,000 new cases reported annually in China, over 50% of which are in individuals aged 60 and above [1] - The Chinese government has made significant advancements in the diagnosis, classification, staging, and treatment of lymphoma, including the implementation of quality control measures for cancer treatment [1][4] - The approval of innovative drugs, such as tanzimab and lenalidomide for treating relapsed/refractory diffuse large B-cell lymphoma (DLBCL), marks a significant step forward in lymphoma treatment in China [2][3] Group 1: Disease Statistics and Trends - Lymphoma is one of the fastest-growing malignant tumors, with a notable increase in younger patients [1] - DLBCL accounts for 30%-40% of adult non-Hodgkin lymphoma (NHL) cases in Western countries and 35%-50% in China, with a median onset age of 50-70 years [3] Group 2: Government Initiatives and Guidelines - The National Cancer Center has initiated pilot projects for standardized diagnosis and treatment quality control for lymphoma, with 60 institutions selected for this purpose in 2023 [1] - The "Healthy China Action - Cancer Prevention and Control Action Implementation Plan (2023-2030)" aims to enhance cancer prevention and control systems, improve early diagnosis and treatment capabilities, and increase the overall five-year survival rate for cancer to 46.6% by 2030 [4] Group 3: Drug Development and Market Impact - The conditional approval of tanzimab for relapsed or refractory follicular lymphoma and its combination with lenalidomide for DLBCL patients represents a significant advancement in treatment options [2] - Clinical studies indicate that tanzimab combined with lenalidomide shows promising efficacy, with an overall response rate (ORR) of 57.5% and a complete response (CR) rate of 41.3% in global studies, and an ORR of 73.1% in Chinese patients [3]

Core Insights - Lymphoma is the 10th most common cancer globally and has the fastest-growing incidence rate among malignant tumors, with approximately 100,000 new cases annually in China, over 50% of which are in individuals aged 60 and above [1][2] - The Chinese government has made significant progress in lymphoma diagnosis, treatment guidelines, and quality control measures, including the establishment of pilot programs for standardized treatment [1][4] - The approval of innovative drugs, such as tanzimab and lenalidomide for treating relapsed/refractory diffuse large B-cell lymphoma (DLBCL), marks a significant advancement in lymphoma treatment options [2][3] Industry Developments - The National Medical Products Administration conditionally approved tanzimab for adult patients with relapsed or refractory follicular lymphoma in November 2022, and its combination therapy for DLBCL was approved in May 2023 [2][3] - Clinical studies show promising results for tanzimab, with an overall response rate (ORR) of 57.5% and a complete response (CR) rate of 41.3% in global studies, while Chinese patients showed an ORR of 73.1% [3] - The 2023 "Healthy China Action - Cancer Prevention and Control Implementation Plan" aims to enhance cancer prevention and treatment capabilities, targeting a 5-year survival rate of 46.6% by 2030 [4][5]

Market Overview - The chemical pharmaceutical sector experienced a decline of 0.34% on September 15, with Nocera leading the drop [1] - The Shanghai Composite Index closed at 3860.5, down 0.26%, while the Shenzhen Component Index rose by 0.63% to 13005.77 [1] Stock Performance - Notable gainers in the chemical pharmaceutical sector included: - Dezhan Health (Code: 000813) with a closing price of 4.72, up 10.02% and a trading volume of 1.0571 million shares [1] - Mengke Pharmaceutical (Code: 688373) closed at 8.13, up 9.57% with a trading volume of 353,100 shares [1] - Tuhua Pharmaceutical (Code: 002262) closed at 28.64, up 6.07% with a trading volume of 277,100 shares [1] - Conversely, Nocera (Code: 688428) saw a significant decline of 8.20%, closing at 27.44 with a trading volume of 175,600 shares [2] Capital Flow - The chemical pharmaceutical sector saw a net outflow of 1.19 billion yuan from institutional investors, while retail investors contributed a net inflow of 582 million yuan [2] - The capital flow for key stocks indicated: - Dezhan Health had a net inflow of 128 million yuan from institutional investors, but a net outflow from retail investors [3] - Nocera experienced a net inflow of 47.59 million yuan from institutional investors, with significant outflows from both retail and speculative investors [3]

Core Viewpoint - The Hong Kong innovative drug sector has rebounded significantly after a previous decline, with several companies experiencing substantial stock price increases, indicating a positive market sentiment despite concerns over potential restrictions from the U.S. on Chinese innovative drugs [2][3][4]. Group 1: Market Performance - After a drop of approximately 3.82% in the innovative drug sector, stocks like Nocera (09969.HK) surged over 14%, nearing historical highs, while others like Hutchison China MediTech (00013.HK) and Zai Lab (09688.HK) also saw significant gains [3][4]. - The A-share market mirrored this trend, with the innovative drug index rising by 1.08%, and notable stocks like Nocera-U (688428.SH) increasing over 12% [3][4]. - Since April 9, the A-share and Hong Kong innovative drug sectors have shown strong growth, with the A-share index up 62% and the Hong Kong index up over 130% as of September 12 [4]. Group 2: Company Developments - Several pharmaceutical companies have acknowledged the rumors regarding U.S. restrictions but believe these do not currently impact the prospects for Chinese innovative drugs entering international markets [4][6]. - Key catalysts for stock price increases include recent approvals for new drugs, such as Nocera's approval for a treatment in Singapore, and positive earnings reports from companies like BeiGene and Innovent Biologics [6][11]. Group 3: Financial Performance - The innovative drug sector is entering a new cycle driven by profitability, with many companies reporting significant revenue growth. For instance, 62% of companies in the sector reported positive revenue growth, and 28% achieved positive net profit [8][11]. - In the first half of 2025, the total revenue for 50 Hong Kong-listed innovative drug companies reached 44.9 billion HKD, a year-on-year increase of 31.48%, with net profits rising by 128.4% [8][11]. - Major companies like BeiGene and Innovent Biologics have reported revenue growth exceeding 40%, marking a significant turnaround in their financial performance [11][12]. Group 4: Policy and Regulatory Environment - Recent policy changes have been favorable for the innovative drug sector, with the National Medical Products Administration optimizing clinical trial review processes to support the development of innovative drugs [3][13]. - The introduction of mechanisms to reduce supply disruption risks in drug procurement policies is expected to benefit innovative drug companies by allowing for a broader evaluation of production quality and supply capabilities [13].

Core Viewpoint - The Hong Kong innovative drug sector has rebounded significantly after a previous decline, with major companies like Nocare and Hutchison Medipharma seeing substantial stock price increases, indicating a positive market sentiment despite concerns over potential restrictions from the U.S. on Chinese innovative drugs [3][5][6]. Market Performance - Following a drop of approximately 3.82% in the innovative drug sector, the market saw a recovery with notable gains: Nocare up over 14%, Hutchison Medipharma up over 11%, and others also showing significant increases [4][5]. - The A-share market mirrored this trend, with the innovative drug index rising by 1.08% [5]. - Since April 9, the A-share and Hong Kong innovative drug sectors have shown strong performance, with the A-share index up 62% and the Hong Kong index up over 130% as of September 12 [6]. Company Performance - A total of 17 innovative drug companies have reached new stock price highs in 2025, with significant increases observed in companies like Baijie Shenzhou and Hengrui Medicine [6]. - Companies that had previously seen their stock prices halved from 2021 to 2024 have experienced substantial recoveries, with some stocks increasing by over 250% in A-shares and over 650% in Hong Kong [7][8]. Financial Results - The innovative drug sector is entering a new profit-driven cycle, with 62% of companies reporting revenue growth and 28% achieving positive net profits in the first half of 2025 [11][16]. - Notably, Baijie Shenzhou and Xinda Biotech achieved profitability for the first time in the first half of 2025, with revenue growth rates exceeding 40% for several leading companies [17]. - The total revenue for 50 Hong Kong innovative drug companies reached 44.9 billion HKD in the first half of 2025, marking a year-on-year increase of 31.48% [11]. Policy and Market Drivers - The recent approval of clinical trial applications for innovative drugs by the National Medical Products Administration is expected to enhance the development of the sector [5]. - The overseas licensing of innovative drugs has seen a significant increase, with total amounts reaching 94.3 billion USD by September 2025, surpassing the total for 2024 [18]. - Policy changes are increasingly favorable for the sector, with recent adjustments to procurement policies aimed at reducing supply chain risks and promoting quality over price [19].