Core Viewpoint - The IPO application of Maijizhi Biotechnology has not yet entered the hearing stage, increasing the likelihood of failure in its listing attempt, despite the acceptance of its core product MG-K10's application by the NMPA [1][6]. Company Overview - Maijizhi Biotechnology, established in 2016, focuses on clinical-stage biopharmaceuticals for allergic and autoimmune diseases, with a pipeline of eight innovative candidates, the most advanced being the long-acting anti-IL-4Rα antibody MG-K10 [2][3]. Product Development - MG-K10 targets the IL-4Rα pathway, which has significant commercial potential, as evidenced by Sanofi's Dupilumab, projected to generate $14.2 billion in sales by 2024. MG-K10 is the only long-acting anti-IL-4Rα candidate validated through Phase III clinical trials as of July 2025 [3][5]. - The global market for atopic dermatitis drugs is expected to grow from $14.2 billion in 2023 to $29.1 billion by 2032, with the Chinese market projected to increase from 8.4 billion RMB to 46.4 billion RMB [5]. Competitive Landscape - The IL-4Rα market in China is highly competitive, with several companies, including Sanofi and CanSino, already having approved products. Multiple candidates are also in Phase III trials, indicating a crowded market upon MG-K10's potential launch [5][6]. Financial Status - Since its inception, Maijizhi has operated at a loss, with cumulative losses exceeding 800 million RMB. The company reported revenues of only 8.72 million RMB, 24,000 RMB, and 0 RMB for 2023 and the first quarter of 2025, respectively [11][12]. - As of March 31, 2025, the company had only 70.78 million RMB in cash, while estimates suggest that completing the global Phase III trials for MG-K10 could require 500 to 600 million RMB [11]. Intellectual Property Challenges - Maijizhi faces significant intellectual property challenges, including ongoing patent disputes with its former parent company, 3SBio. The company has been involved in two patent disputes regarding the IL-4Rα target, which could impact the commercial viability of MG-K10 [9][10]. - The stability of core patents is crucial for the commercial value of MG-K10, as any invalidation could pose substantial risks to its market exclusivity [10]. Investment and Financing - The company has raised over 700 million RMB through multiple financing rounds since its establishment, with a post-money valuation increasing nearly 45 times over eight years [12]. - However, the financial structure is concerning, with a debt-to-asset ratio exceeding 100% for several years, indicating a precarious financial position [12]. Future Obligations - Investors have stipulated that if Maijizhi does not complete a qualified IPO or merger by December 31, 2025, they have the right to require the company or its founders to repurchase shares at principal plus 12% interest, adding pressure to meet listing deadlines [13].

Core Viewpoint - The report from Guoyuan International highlights that Kangzhe Pharmaceutical (00867) has established a global pipeline of 40 innovative drugs primarily focused on FIC and BIC, with 5 approved innovative drugs accelerating commercial value release, 7 NDA reviews ongoing, and over 10 clinical trials in progress. The oral JAK1 inhibitor Povorcitinib has received breakthrough therapy designation, and a "Buy" rating is given with a target price of HKD 17.68 per share [1]. Group 1: Innovative Drug Pipeline - The company has a rich pipeline of innovative drugs, with 40 global projects focused on FIC and BIC, and 5 approved innovative drugs accelerating commercial value [2]. - The NDA application for the first-class injectable drug Y-3 has been accepted, which is the world's first brain cell protector developed based on PSD95-nNOS and MPO targets, expected to address both stroke treatment and post-stroke depression and anxiety [2]. - The market potential for injectable Y-3 is estimated at RMB 3 billion [2]. Group 2: Clinical Trials and Market Demand - The oral JAK1 inhibitor Povorcitinib has received breakthrough therapy designation from China's NMPA, targeting adult non-segmental vitiligo, with a large unmet treatment demand in China, where there are approximately 10.3 million vitiligo patients, including 8.2 million with non-segmental vitiligo [2]. - Multiple clinical trials for Povorcitinib are ongoing in various countries, including Phase III trials for non-segmental vitiligo and moderate to severe hidradenitis suppurativa, as well as a Phase II asthma trial [2]. Group 3: Financial Performance - In the first half of 2025, the company achieved revenue of RMB 4.67 billion, a year-on-year increase of 8.9%, and a net profit of RMB 930 million, up 3.1% year-on-year [3]. - The skin health line generated revenue of RMB 498 million, a significant increase of 104.3%, accounting for 10.7% of the group's drug sales [3]. - The company's brand and innovative products generated a total revenue of RMB 2.9 billion, a year-on-year growth of 20.6%, representing 62.1% of total revenue [3]. Group 4: Investment Recommendations - The company's performance is expected to recover, with a significant optimization of its product structure focusing on innovative drugs. Revenue projections for 2025-2027 are RMB 7.86 billion, RMB 8.95 billion, and RMB 10.02 billion, with net profits of RMB 1.667 billion, RMB 1.941 billion, and RMB 2.308 billion respectively [4]. - The target price of HKD 17.68 corresponds to a PE ratio of 16.9 times for 2027, indicating a potential upside of 32% from the current price [4].

Core Viewpoint - Company has a rich pipeline of innovative drugs, with 40 products globally focused on FIC and BIC, including 5 approved innovative drugs accelerating commercial value [1][2] Group 1: Innovative Drug Pipeline - The company has 40 innovative drugs in its pipeline, with 5 approved drugs that are beginning to release commercial value [2] - 7 NDA applications are under review, and over 10 clinical trials are progressing [2] - The first-in-class injectable Y-3 has received NMPA acceptance for its new drug application, targeting stroke treatment and post-stroke depression and anxiety [2] Group 2: Market Potential and Clinical Trials - The market potential for injectable Y-3 is estimated at 3 billion RMB [2] - The oral JAK1 inhibitor Povorcitinib has received breakthrough therapy designation in China, targeting adult non-segmental vitiligo, with a large unmet treatment need [2] - There are approximately 10.3 million vitiligo patients in China, with 8.2 million being non-segmental [2] Group 3: Financial Performance - In the first half of 2025, the company achieved revenue of 4.67 billion RMB, a year-on-year increase of 8.9%, and a net profit of 930 million RMB, up 3.1% [3] - The skin health line generated revenue of 498 million RMB, a significant increase of 104.3%, accounting for 10.7% of total drug sales [3] - Brand and innovative products accounted for 2.9 billion RMB in sales, a 20.6% increase, representing 62.1% of total revenue [3] Group 4: Investment Recommendations - The company's performance is expected to recover, with a significant optimization of its product structure towards innovative drugs [4] - Projected revenues for 2025-2027 are 7.86 billion, 8.95 billion, and 10.02 billion RMB, with net profits of 1.667 billion, 1.941 billion, and 2.308 billion RMB respectively [4] - The target price is set at 17.68 HKD per share, implying a 32% upside from the current price [4]

Core Viewpoint - 康哲药业's subsidiary 德镁医药 has received approval from the NMPA for its innovative oral JAK1 inhibitor povorcitinib, aimed at treating non-segmental vitiligo in adults, which is expected to accelerate the product's development and review process in China [1][2] Group 1 - The product povorcitinib has been included in the list of breakthrough therapeutic drugs, which is anticipated to expedite its research and review process in mainland China [2] - If approved for sale in China, povorcitinib is expected to synergize with 德镁医药's existing innovative drugs, enhancing clinical and commercial value for skin disease patients [2] - The product will provide differentiated and comprehensive treatment options for vitiligo patients alongside the topical formulation of phosphoric acid alfacalcidol [2] Group 2 - On March 31, 2024, the company entered into a collaboration and licensing agreement with Incyte for povorcitinib, securing exclusive rights for research, development, registration, and commercialization in mainland China, Hong Kong, Macau, Taiwan, and eleven Southeast Asian countries [2] - The subsidiary has sublicensed rights for povorcitinib in regions outside mainland China back to the company, excluding 德镁医药 and its subsidiaries [2]

Core Viewpoint - 康哲药业's subsidiary 德镁医药 has received approval from the NMPA for its innovative oral JAK1 inhibitor povorcitinib, which is expected to accelerate the drug's development and review process in China for treating non-segmental vitiligo [1][2] Group 1: Product Development - Povorcitinib is a selective oral small molecule JAK1 inhibitor with substance and use patents in specific countries/regions [1] - The drug is currently undergoing Phase 3 clinical trials for non-segmental vitiligo, moderate to severe hidradenitis suppurativa, and nodular prurigo in several overseas countries, along with a Phase 2 trial for asthma [1] Group 2: Market Potential - The inclusion of povorcitinib in the breakthrough therapy list is expected to expedite its research and review process in mainland China, potentially leading to a faster market launch [2] - If approved, povorcitinib will complement 德镁医药's existing innovative drugs, enhancing clinical and commercial value for skin disease patients [2] - The product will provide differentiated and comprehensive treatment options for vitiligo patients alongside the topical formulation of phosphoric acid lukotinin ointment [2] Group 3: Licensing and Collaboration - On March 31, 2024, 德镁医药 entered into a collaboration and licensing agreement with Incyte for povorcitinib, securing exclusive rights for research, development, registration, and commercialization in mainland China, Hong Kong, Macau, Taiwan, and eleven Southeast Asian countries [2] - The subsidiary has sublicensed rights for regions outside mainland China, excluding 德镁医药 and its subsidiaries [2]

Core Viewpoint - 康哲药业's subsidiary, 德镁医药, is applying for an independent listing on the Hong Kong Stock Exchange, focusing on innovative pharmaceuticals for skin health [1] Group 1: Company Developments - 德镁医药 has received approval from the National Medical Products Administration (NMPA) for its innovative oral JAK1 inhibitor, povorcitinib, to be included in the list of breakthrough therapies [1] - The proposed indication for povorcitinib is for adult patients with non-segmental vitiligo, which is expected to accelerate the product's research and review process [1] Group 2: Market Implications - The listing on the Hong Kong Stock Exchange is scheduled for April 22, 2025, indicating a strategic move to enhance capital and visibility in the market [1]

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。 二零二五年八月，德鎂醫藥獲NMPA簽發的藥物臨床試驗批准通知書，同意開展 povorcitinib用於治療非節段型白癜風等適應症的臨床試驗。德鎂醫藥已啓動產品在中國 的臨床開發工作，並考慮擇機在中國推動其治療HS和結節性癢疹等皮膚相關疾病的臨 *僅供識別 1 CHINA MEDICAL SYSTEM HOLDINGS LIMITED 康哲藥業控股有限公司* （於開曼群島註冊成立的有限公司） （香港股份代號：867） （新加坡股份代號：8A8） 自願性及業務進展公告 創新藥口服小分子JAK1抑制劑Povorcitinib 納入突破性治療品種名單 China Medical System Holdings Limited（「本公司」，連同其附屬公司統稱為「本集團」） 欣然宣佈，旗下德鎂醫藥有限公司（「德鎂醫藥」，專業聚焦皮膚健康的創新型醫藥企 業，正申請於香港聯合交易所有限公司主板獨立上市，詳見本公司日期為二零二 ...

Core Viewpoint - Kangzheng Pharmaceutical's new drug application for Y-3 has been officially accepted by the National Medical Products Administration, targeting acute ischemic stroke treatment and potentially preventing post-stroke depression and anxiety symptoms [1][2] Group 1: Product Development - Y-3 is the world's first multi-target neuroprotective agent aimed at PSD95-nNOS and MPO, showing promising efficacy in treating ischemic stroke [1] - The company has established a strong presence in the central nervous system field, with a product portfolio that includes the marketed innovative drug Vituco and the original brand drug Dailixin, along with the NDA-reviewed modified new drug ZUNVEYL [1] Group 2: Clinical Research and Impact - The burden of stroke-related disabilities has increased over the past thirty years, with post-stroke depression and anxiety affecting approximately 30% and 25% of patients, respectively [2] - Y-3 has reached its primary efficacy endpoint in Phase III clinical trials in China, demonstrating significant clinical benefits and good overall safety [2] - The main research results for Y-3 are planned to be presented at international academic conferences, with the overall study set to be published in international academic journals [2]

Group 1 - The core point of the news is that Kangzheng Pharmaceutical has received acceptance for the New Drug Application (NDA) of its innovative drug Y-3 for the treatment of acute ischemic stroke by the National Medical Products Administration (NMPA) in China [1] - Y-3 is the world's first brain cell protector developed based on key pathological targets PSD95-nNOS and MPO, which acts on multiple critical pathological processes of ischemic stroke [1] - The Phase III clinical study of Y-3 in China has achieved its primary efficacy endpoint, showing significant clinical benefits for patients and good overall safety [1] Group 2 - In China, approximately 3.94 million new stroke cases occur annually, accounting for one-third of global new cases, with ischemic stroke making up about 72% of these cases [2] - The burden of stroke-related disabilities has been increasing over the past thirty years, compounded by an aging population, leading to greater challenges for stroke prevention and control [2] - Post-stroke depression and anxiety are common complications, with incidence rates of about 30% and 25%, respectively, which can affect neurological recovery and increase mortality risk [2] Group 3 - Kangzheng Pharmaceutical has established a deep product layout in the central nervous system field, which is one of its core strengths [2] - If Y-3 is approved, it will synergize with existing innovative drugs such as Vitoqu (for cluster epilepsy) and the original brand drug Dailixin (for anxiety and depression), as well as the modified new drug ZUNVEYL (for Alzheimer's disease) under NDA review [2] - The company aims to leverage its excellent commercialization experience and efficient operational system to accelerate the availability of innovative therapies for more patients [2][3]

Core Viewpoint - Kangzheng Pharmaceutical (00867.HK) has received acceptance for its New Drug Application (NDA) for the injection Y-3, a brain cell protective agent intended for acute ischemic stroke, from the National Medical Products Administration (NMPA) of China on December 11, 2025 [1] Group 1 - The product Y-3 is classified as a Class 1 new drug [1] - The intended use of Y-3 is for the protection of brain cells in cases of acute ischemic stroke [1] - The NDA acceptance marks a significant step in the product's development and potential market entry [1]