Core Viewpoint - 康哲药业's subsidiary 德镁医药 is applying for an independent listing on the Hong Kong Stock Exchange and has received acceptance for its new drug application for MG-K10, an innovative long-acting anti-IL-4Rα monoclonal antibody, which is intended for the treatment of moderate to severe atopic dermatitis in adults [1][2]. Group 1: Product Development and Clinical Trials - MG-K10 is designed to block key type 2 inflammatory factors IL-4 and IL-13 signaling pathways and has shown positive results in a Phase III clinical trial for adult moderate to severe atopic dermatitis, achieving primary endpoints [2]. - In the clinical trial, 76.6% of participants achieved an Investigator's Global Assessment (IGA) score of 0 or 1, with at least a 2-point improvement from baseline, while 94.3% achieved at least a 75% improvement in the Eczema Area and Severity Index (EASI75) [2]. - The drug has a longer half-life allowing for administration every four weeks, compared to existing anti-IL-4Rα drugs that require biweekly dosing, positioning MG-K10 as a potential Best-in-Class treatment [2]. Group 2: Future Potential and Indications - MG-K10 has potential applications for other type 2 inflammatory diseases, including asthma, nodular prurigo, seasonal allergic rhinitis, chronic obstructive pulmonary disease, chronic spontaneous urticaria, chronic sinusitis with nasal polyps, and eosinophilic esophagitis [3]. - Clinical trials for asthma, nodular prurigo, and seasonal allergic rhinitis have already entered Phase III in China [3].

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其 準確性或完整性亦不發表任何聲明，並表明概不就因本公告全部或任何部分內容而產生 或因倚賴該等內容而引致的任何損失承擔任何責任。 自願性及業務進展公告 長效抗IL-4Rα人源化單抗注射液特應性皮炎適應症 中國上市許可申請已獲受理 性肺疾病、慢性自發性蕁麻疹、慢性鼻竇炎伴鼻息肉及嗜酸性粒細胞性食管炎等。其中， 哮喘、結節性癢疹和季節性過敏性鼻炎均已進入中國III期臨床試驗階段。 特應性皮炎（AD） MG-K10的首發適應症AD是一種伴有劇烈瘙癢的慢性炎症性皮膚病，是全球疾病負擔最 高的非致命性皮膚病，同時也是我國患病率較高、疾病負擔較重的慢性疾病。據估算， 2024年中國特應性皮炎患者超過5,400萬人，基於SCORAD評分，中重度特應性皮炎的 占比為27%，即超過1,450萬患者。由於傳統AD系統治療藥物療效及安全性等方面的不 足，在臨床中，中重度AD患者啟動系統治療往往較晚、依從性不佳、總體控制率較低， 臨床上仍存在大量未被滿足的治療需求。MG-K10給藥間隔更長，每4週給藥一次，有望 提升患者依從性，給中重度AD患者帶來新的有效且安 ...

Group 1 - The core point of the article is that innovative drug developments and partnerships are shaping the competitive landscape in the pharmaceutical industry, with significant implications for market performance and patient care [1][2][4]. Group 2 - Xinda Biopharma's dual receptor agonist, Masitide, achieved primary endpoints in its Phase III clinical trial, demonstrating superior efficacy in blood sugar control and weight management compared to Semaglutide in Chinese patients with type 2 diabetes and obesity [1]. - Kangzhe Pharmaceutical signed an exclusive distribution agreement with Novartis for two ophthalmic drugs, which is expected to enhance the company's academic brand competitiveness and positively impact its performance [2]. - Sanbo Brain Science reported a 20% decrease in net profit for the first three quarters of 2025, despite a 20.26% increase in revenue, indicating potential challenges such as rising costs and market competition [3]. - Wanbangde's subsidiary received orphan drug designation from the FDA for WP203A, which is under development for treating pemphigus, providing the company with various regulatory advantages in the U.S. market [4].

Group 1 - Xinda Biologics announced that its GCG/GLP-1 dual receptor agonist, Masitide, achieved its primary endpoint in the Phase III clinical trial DREAMS-3, showing significant efficacy in blood glucose control and weight management compared to Semaglutide in Chinese patients with type 2 diabetes and obesity [1] - The key research for Masitide was primarily conducted in the Chinese patient population, indicating that its dosage selection, tolerability, and weight loss trends are more aligned with local metabolic characteristics and clinical needs [1] Group 2 - Kangzhe Pharmaceutical signed an exclusive distribution agreement with Novartis for two ophthalmic drugs, Ranibizumab injection (trade name: Noshide) and Brolucizumab injection (trade name: Beiyoushi), with a collaboration period of five years [2] - The addition of Noshide and Beiyoushi is expected to enhance the company's academic brand competitiveness and promote the continuous development of urgently needed innovative ophthalmic products, positively impacting the group's performance [2] Group 3 - Sanbo Brain Science reported a 20% decrease in net profit for the first three quarters of 2025, despite a 20.26% increase in revenue to approximately 1.273 billion yuan [3] - The decline in net profit suggests potential challenges such as rising costs, intensified market competition, or adjustments in business structure, necessitating careful consideration of the company's long-term strategy and short-term performance fluctuations by investors [3] Group 4 - Wanbangde's subsidiary received orphan drug designation from the FDA for its product WP203A (Afanotide) for the treatment of pemphigus, with the long-acting formulation currently under development [4] - The orphan drug designation provides the company with policy support in the U.S., including tax credits for clinical trial costs, exemption from new drug application fees, and seven years of market exclusivity post-approval, which will accelerate the company's international drug development process [4]

Core Viewpoint - The collaboration between 康哲药业 and Novartis Pharma Services AG aims to enhance the competitive edge of 康哲维盛 in the ophthalmology sector through exclusive rights for the import, distribution, and promotion of two key products in mainland China [1][2] Group 1: Agreement Details - 康哲药业 has signed a distribution agreement with Novartis for 雷珠单抗注射液 (诺适得) and 布西珠单抗注射液 (倍优适) [1] - The agreement grants 康哲药业 exclusive rights for import, distribution, sales, and promotion in mainland China, while Novartis will continue to handle production and supply [1] - The duration of the collaboration is set for five years from the effective date of the agreement [1] Group 2: Impact on Business - The partnership is expected to enhance 康哲维盛's overall competitiveness in the ophthalmology field, which already covers conditions such as retinal diseases, visual fatigue, and glaucoma [2] - The introduction of 诺适得 and 倍优适 will synergize with existing products like the exclusive drug 施图伦滴眼液 and the EyeOP1 glaucoma treatment device, improving academic brand competitiveness [2] - 康哲维盛's specialized ophthalmology team will integrate market channels and academic resources, leading to improved overall team efficiency and a positive impact on the company's performance [2]

Core Insights - 康哲药业 has signed a distribution agreement with Novartis for the exclusive import, distribution, sales, and promotion rights of two ophthalmic products in mainland China, which is expected to enhance its competitiveness in the ophthalmology sector and positively impact its performance [1][2] Group 1: Agreement Details - The agreement grants 康哲药业 exclusive rights for 雷珠单抗注射液 ("诺适得") and 布西珠单抗注射液 ("倍优适") in China for a duration of five years, while Novartis will continue to handle production and supply [1] - Both products are already approved for sale in China, with "诺适得" being the first anti-VEGF drug approved for ophthalmology in the country and "倍优适" being the smallest molecular weight anti-VEGF drug [1][2] Group 2: Market Context - "诺适得" is approved for multiple retinal neovascular diseases, including wet age-related macular degeneration (nAMD) and diabetic macular edema (DME), and was included in the National Basic Medical Insurance Drug List in 2017 [2] - "倍优适" is expected to be approved for DME by May 2025, with an estimated 7.89 million DME patients in China by that year, indicating a strong demand for effective treatment options [2] - The collaboration is anticipated to create synergies with existing products in 康哲维盛's portfolio, enhancing its market presence in various ophthalmic conditions [2]

Core Insights - The company, Kangzheng Pharmaceutical, has signed a distribution agreement with Novartis Pharma Services AG for the exclusive import, distribution, sales, and promotion rights of two ophthalmic products in mainland China [1][2] - The collaboration is expected to enhance the competitiveness of Kangzheng Weisheng in the ophthalmology sector, which already covers various eye diseases [2] Group 1 - The agreement grants Kangzheng exclusive rights for the products Ranibizumab Injection (trade name: 诺适得) and Brolucizumab Injection (trade name: 倍优适) for a period of five years [1] - Novartis will continue to be responsible for the production and supply of these products [1] - Novartis is a globally recognized pharmaceutical company focusing on four core therapeutic areas and five key technology platforms [1] Group 2 - The addition of these products is expected to create synergies with existing offerings, enhancing academic brand competitiveness in the ophthalmology field [2] - Kangzheng Weisheng's professional ophthalmology team will integrate market channels and academic resources to improve overall team efficiency [2] - The anticipated outcome of this collaboration is a positive impact on the company's performance and a broader range of treatment options for patients with eye diseases [2]

Core Viewpoint - 康哲药业 has signed a distribution agreement with Novartis Pharma Services AG for the exclusive import, distribution, sales, and promotion rights of two ophthalmic products in mainland China, enhancing its competitive position in the ophthalmology sector [1][2] Group 1: Agreement Details - The agreement grants 康哲药业 exclusive rights for 雷珠单抗注射液 (诺适得®) and 布西珠单抗注射液 (倍优适®) in mainland China, excluding Hong Kong, Macau, and Taiwan [1] - The collaboration will last for five years from the effective date of the agreement [1] Group 2: Strategic Impact - The partnership is expected to enhance 康哲维盛's overall competitiveness in the ophthalmology field, which already covers diseases such as retinal diseases, visual fatigue, and glaucoma [2] - The introduction of 诺适得® and 倍优适® will synergize with existing products, including the exclusive drug 施图伦滴眼液 and the EyeOP1 glaucoma treatment device, improving academic brand competitiveness and providing diverse treatment options for patients [2] - 康哲维盛's specialized ophthalmology team will integrate market channels and academic resources, leading to improved overall team efficiency and a positive impact on the company's performance [2]

Group 1 - The company, Kangzheng Pharmaceutical, has signed a distribution agreement with Novartis Pharma Services AG for the exclusive import, distribution, sales, and promotion rights of two injectable products in mainland China [1][2] - The agreement covers the products Lezhu Single Antibody Injection (brand name: Noshide) and Busizhu Single Antibody Injection (brand name: Beiyoushi), with Novartis responsible for production and supply [1] - The collaboration is set to last for five years from the effective date of the agreement [1] Group 2 - This partnership is expected to enhance the competitiveness of Kangzheng Weisheng in the ophthalmology sector, which already covers diseases such as retinal diseases, visual fatigue, and glaucoma [2] - The addition of Noshide and Beiyoushi will synergize with existing products, including the exclusive eye drop medication and glaucoma treatment device, improving academic brand competitiveness in the ophthalmology field [2] - The professional ophthalmology team at Kangzheng Weisheng will integrate market channels and academic resources, leading to improved overall team efficiency and a positive impact on the company's performance [2]

Group 1 - The company, Kangzheng Pharmaceutical, has signed a distribution agreement with Novartis Pharma Services AG for the exclusive import, distribution, sales, and promotion rights of two ophthalmic products in mainland China [1][2] - The agreement covers the products Ranibizumab Injection (trade name: 诺适得®) and Brolucizumab Injection (trade name: 倍优适®) for a duration of five years [1] - Novartis will continue to be responsible for the production and supply of these products [1] Group 2 - This collaboration is expected to enhance the competitiveness of Kangzheng Weisheng, the company's ophthalmology division, in the field of eye diseases [2] - The addition of these products will synergize with existing offerings, including the exclusive drug and medical device currently available, thereby strengthening the academic brand competitiveness in ophthalmology [2] - The professional ophthalmology team at Kangzheng Weisheng will integrate market channels and academic resources, which is anticipated to have a positive impact on the company's overall performance [2]