Core Viewpoint - The collaboration between Nocera and Zenas marks a significant milestone in the internationalization process of Nocera, accelerating the global development and commercialization of its products, including Obeticholic Acid [1] Group 1: Internationalization and Partnerships - The partnership with Zenas is highlighted as a crucial step in Nocera's international expansion efforts [1] - The collaboration is expected to expedite the development and commercialization of Obeticholic Acid and other pipeline products globally [1] Group 2: Product Development Timeline - Obeticholic Acid is set to initiate Phase III trials for Primary Progressive Multiple Sclerosis (PPMS) in Q3 2025 and for Secondary Progressive Multiple Sclerosis (SPMS) in Q1 2026 [1] - The Phase III registration clinical trial for Obeticholic Acid in Immune Thrombocytopenic Purpura (ITP) in China has completed patient enrollment, with a market application submission expected in the first half of 2026 [1] - Zenas's core pipeline product, Obexelimab, is anticipated to report 12-week primary endpoint data from its Phase II clinical trial in the RMS field in Q4 2025, with 24-week data expected in Q1 2026 [1] Group 3: Product Pipeline and Market Position - Nocera has a comprehensive pipeline in hematological malignancies, autoimmune diseases, and solid tumors, indicating a broad market presence [1] - The core products are expected to drive performance, with ongoing advancements in the hematological, autoimmune, and solid tumor pipelines [1] - The successful business development (BD) of products like Obeticholic Acid is seen as a continuous coverage strategy for the company [1]

Core Viewpoint - The innovative drug sector is experiencing a rebound, with the Hang Seng Hong Kong Stock Connect Innovative Drug Index rising by 2.54% as of 15:15. The recent fluctuations in the sector are attributed to the digestion of previous positive news and geopolitical concerns, rather than a reversal in industry trends. The recognition of Chinese innovative drugs by overseas pharmaceutical companies has shifted from a "stock selection" approach to a "country-level" strategic focus, making China a core supplier in the global innovative drug landscape [1]. Group 1: Market Dynamics - The innovative drug sector is currently undergoing a fundamental transformation in its business development (BD) logic, with overseas companies increasingly recognizing the importance of Chinese innovative drugs [1]. - The current slowdown in BD transaction activity is viewed as a minor fluctuation within a longer-term trend, rather than a sign of a significant downturn [1]. Group 2: Upcoming Catalysts - The fourth quarter is expected to be a period of intensive catalysts for the innovative drug sector, with major academic conferences such as ESMO, ASH, and SABCS set to present key clinical data from Chinese innovative drugs, which could enhance market confidence if results exceed expectations [2]. - The traditional peak season for BD transactions is anticipated in October and November, with significant deals already initiated, such as the one involving Innovent Biologics, which may validate long-term industry logic [2]. - Policy adjustments, both domestically and internationally, are expected to support the innovative drug sector, including the opening of a window for adjustments to the medical insurance catalog and the potential benefits from a renewed interest in interest rate cuts by the Federal Reserve [2]. Group 3: Related Investment Vehicles - Relevant investment vehicles include the Hang Seng Innovative Drug ETF (159316), Hong Kong Stock Connect Pharmaceutical ETF (513200), and Pharmaceutical ETF (512010), which provide exposure to the innovative drug sector [3].

Investment Rating - The report maintains an "Outperform" rating for the biopharmaceutical industry [1]. Core Insights - The report is optimistic about the trend of innovative drugs, particularly focusing on the upcoming ESMO conference and national medical insurance negotiations [1][3]. - The innovative drug sector is expected to experience a qualitative change driven by quantitative growth over the next 5-10 years, with business development (BD) overseas, continuous data catalysts, and new product sales driving the rise of innovative drugs [3]. Summary by Sections 1. Innovative Drug Highlights - uniQure's gene therapy AMT-130 for Huntington's disease showed significant results in a key I/II clinical trial, with a 75% reduction in disease progression at high doses [3][5]. - Novartis acquired Akero Therapeutics for $5.2 billion, focusing on FGF21-targeted therapies for MASH, with the core asset being efruxifermin, currently in Phase III trials [22][23]. - The report emphasizes the importance of clinical data from the upcoming ESMO conference and the third-quarter earnings reports, as well as the November national medical insurance negotiations [3]. 2. Industry Catalysts and Strategies - The report suggests focusing on companies with strong clinical data, commercialization capabilities, and potential for successful international expansion, recommending specific companies in both the Biopharma and Pharma sectors [3]. - Suggested companies include: - Pharma: CSPC Pharmaceutical Group, China Biologic Products, and Hengrui Medicine [3]. - Biopharma: Innovent Biologics, Kelun-Biotech, and Zai Lab [3]. 3. Investment Recommendations - The report recommends a dual focus on Biotech and generic-to-innovative companies with potential catalysts, highlighting specific companies in each category [3]. - Suggested Biotech companies include: EdiGene, CanSino Biologics, and I-Mab Biopharma [3]. - Suggested generic-to-innovative companies include: Jingxin Pharmaceutical, Enhua Pharmaceutical, and Changchun High-tech [3].

Core Viewpoint - The collaboration between Nocera and Zenas, valued at over $2 billion, aims to accelerate the global clinical development of obexelimab, enhancing its global value despite market skepticism due to recent stock fluctuations [1][2]. Group 1: Transaction Purpose and Financial Aspects - The primary goal of the transaction is to expedite the global multi-center clinical development of obexelimab, with Nocera under no cash flow pressure [1]. - The upfront payment includes $100 million in cash and 7 million shares, totaling nearly $300 million, providing immediate financial and equity benefits to Nocera [1][4]. - Zenas is expected to pay a tiered royalty of 17%-19% on sales, along with milestone payments, indicating Zenas's strong recognition of obexelimab's potential value [4]. Group 2: Strategic Fit and Development Capability - The high compatibility between Nocera and Zenas is crucial, as Zenas specializes in the autoimmune field, allowing focused resource allocation to obexelimab [5]. - Zenas's leadership team has extensive experience in the autoimmune sector, enhancing clinical development efficiency [5]. - Zenas's strategy combines experienced leadership with a rigorous candidate product portfolio, aiming to discover and develop products that provide excellent clinical efficacy for autoimmune disease patients [5]. Group 3: Clinical Development and Financial Health - Zenas plans to release key data from the obexelimab clinical trial for relapsing multiple sclerosis (RMS) by Q4 2025, with a peak sales potential of $3 billion for its first commercialized product [6]. - Zenas reported a cash balance of $275 million with no debt, indicating a healthy balance sheet, and has recently completed financing rounds totaling up to $300 million [6]. - The collaboration allows Nocera to alleviate financial burdens associated with international clinical trials while benefiting from Zenas's expertise [7]. Group 4: Market Confidence - In response to recent market corrections in the innovative drug sector, the company demonstrated confidence by repurchasing shares worth nearly HKD 12 million [9].

Core Insights - The "Double Ten Law" highlights the high threshold of "ten years of R&D and one billion USD" that every innovative pharmaceutical company must face, including Nocare Pharma [1][6] - Nocare Pharma's sustainable development is supported by significant R&D investments, which accounted for over 90% of its revenue in the past three years, totaling over 2.2 billion RMB [1][7] - The company has successfully transitioned from relying on external funding to achieving self-sustaining revenue through its core product, Oubatinib, which has surpassed 1 billion RMB in annual sales [1][8] Company Development - Nocare Pharma was established in 2015, focusing on innovative drug development for malignant tumors and autoimmune diseases, with several indications successfully approved for market [3] - Oubatinib, the company's first commercial product, is the first BTK inhibitor in the autoimmune disease field in China, with three indications approved and included in the national medical insurance directory by the end of 2024 [3][4] Financial Performance - In the first quarter of 2025, Nocare Pharma achieved a significant milestone by recording its first quarterly profit, with revenue of 381 million RMB, a year-on-year increase of 129.92% [8] - The company reported a net profit of 18 million RMB, a substantial improvement from a loss of 142 million RMB in the same period last year [8] Business Development - Nocare Pharma has engaged in strategic business development (BD) partnerships to enhance its profitability, including a collaboration with Prolium that could yield up to 5.025 billion RMB in milestone payments [8][9] - A recent licensing agreement with Zenas BioPharma for Oubatinib and two preclinical assets could generate over 2 billion USD in total, marking a record for small molecule licensing in China's autoimmune field [9]

Group 1 - The core viewpoint of the news is that Nocera Biopharma experienced a significant drop in stock price, with a 9.16% decline on October 10, 2023, and a trading volume of 490 million yuan [1] - On the same day, Nocera Biopharma had a financing buy-in amount of 50.08 million yuan, with a net financing buy of 16.32 million yuan, indicating strong investor interest despite the stock price drop [1] - The total financing and securities balance for Nocera Biopharma reached 287 million yuan, accounting for 4.40% of its circulating market value, which is above the 90th percentile of the past year, indicating a high level of financing activity [1] Group 2 - Nocera Biopharma, established on November 3, 2015, and listed on September 21, 2022, focuses on the research, production, and commercialization of biopharmaceuticals, particularly in oncology and autoimmune diseases [2] - The company's revenue composition shows that 87.67% comes from drug sales, 12.04% from technology licensing, and minimal contributions from testing and research services [2] - For the first half of 2025, Nocera Biopharma reported a revenue of 731 million yuan, representing a year-on-year growth of 74.26%, while the net profit attributable to shareholders was -30.09 million yuan, an increase of 88.51% compared to the previous period [2] Group 3 - As of June 30, 2025, the top ten circulating shareholders of Nocera Biopharma included several funds, with notable changes in holdings, such as an increase of 3.98 million shares by China Europe Medical Health Mixed A [3] - New entrants among the top shareholders include E Fund Innovative Medicine Mixed A and Yifangda Medical Health Industry Mixed A, indicating a shift in institutional interest [3] - The exit of certain funds like Xingquan Helun Mixed A and Ping An Medical Health Mixed A from the top ten shareholders suggests a reallocation of investment strategies among institutional investors [3]

Investment Rating - The report maintains a "Recommended" investment rating for the pharmaceutical industry [1] Core Insights - The trend of Chinese innovative drugs going overseas is a long-term phenomenon, with external environmental changes having limited impact. In the first half of 2025, there were 72 License-out transactions, exceeding half of the total for 2024, with a total transaction amount 16% higher than in 2024. Notably, there were 16 transactions exceeding $1 billion each [2] - The small nucleic acid drug sector has seen significant breakthroughs, particularly in the treatment of chronic diseases such as hypertension and hyperlipidemia, with major collaborations and potential milestone payments indicating a robust commercial outlook [3] - The trend towards oral autoimmune drugs is gaining attention, with significant partnerships and clinical advancements in this area, highlighting the importance of oral formulations in autoimmune therapies [4] - Recent clinical data on long-acting insulin analogs shows promising weight loss results, with ongoing developments in combination therapies for metabolic diseases, indicating a growing market potential [5] - The CXO sector is gradually recovering, with an increase in License-out transactions serving as a vital funding source for biotech companies, leading to a resurgence in innovation and clinical development [6] - The 2025 national medical insurance negotiations and the commercial insurance innovative drug directory are crucial for companies involved, with a focus on orphan drugs and imported PD-1/L-1 products [7] Summary by Sections Industry Tracking - The pharmaceutical sector has underperformed compared to the CSI 300 index, with a recent weekly decline of 1.20% and a monthly decline of 3.38%, ranking 25th among 31 industry indices [22][26] Industry Trends and Valuation - The pharmaceutical industry index currently has a PE ratio of 39.05, above the five-year historical average of 31.36, indicating a higher valuation compared to historical trends [48][50] Recent Research Achievements - The research team has published several in-depth reports on various pharmaceutical topics, including the growth of the blood products industry and the potential of GLP-1 drugs in chronic disease management [53] Important Policies and News - Recent regulations have been introduced to standardize clinical research and ensure drug traceability, which will impact the pharmaceutical landscape significantly [55][56]

Group 1 - Debon Logistics has launched a logistics line connecting China to six Middle Eastern countries, including the UAE and Saudi Arabia, with tailored customs and delivery solutions for various product categories [5][6] - Temu has partnered with e-commerce platform Base.com to enhance operational efficiency for cross-border sellers in markets like the UK and the US, offering streamlined order fulfillment and inventory management [5][6] - SHEIN plans to open its first physical stores in France in November, marking its first foray into brick-and-mortar retail after focusing primarily on online sales [6] Group 2 - TikTok is testing a self-operated e-commerce feature called "Trendy Beat" in the UK, aiming to sell products directly sourced by TikTok, enhancing its e-commerce strategy [6] - Xiaomi is accelerating its European expansion by opening flagship stores in Germany and Spain, with plans to sell electric vehicles by 2027 [7] - BYD has officially rolled out its 14 millionth new energy vehicle in Brazil, with the Brazilian president becoming a car owner, highlighting BYD's dominance in the Brazilian market [8] Group 3 - Hesai Technology has become the first company globally to produce over one million lidar units annually, maintaining a leading market share in the ADAS sector [8] - Natural堂 has completed a new financing round, raising 300 million RMB, with a valuation exceeding 7 billion RMB, and plans for an IPO in Hong Kong [9] - Anlan Power has secured angel funding to develop electric smart jet skis, targeting markets in North America, Europe, and emerging regions [9] Group 4 - Dap Bio has completed a Series B financing round to accelerate the global commercialization of its high-end life science instruments, focusing on drug discovery and synthetic biology [9] - Saudi Arabia will implement new freight regulations requiring advance declaration of cargo through the FASAH platform, effective October 29, 2025, to enhance logistics efficiency [11] - The trend of Chinese innovative drugs going global continues, with notable partnerships and licensing agreements, reflecting the global recognition of China's R&D capabilities [12]

Core Viewpoint - The A-share and Hong Kong stock markets experienced significant fluctuations, with the A-share medical sector facing downward pressure, particularly in the CXO segment, while the innovative drug sector remains a focal point for investors despite recent adjustments [1][5][7]. Group 1: A-share Market Performance - The A-share medical sector opened lower and continued to decline, with major player WuXi AppTec leading the drop at 7.2%, and the largest medical ETF (512170) falling by 2.03% [1]. - The overall trend for the medical sector has been a recent upward movement, indicating potential for rebound despite short-term corrections [1]. Group 2: Hong Kong Market Performance - The Hong Kong medical sector initially showed signs of recovery but faced renewed selling pressure, with innovative drug stocks like Rongchang Bio and Innovent Biologics dropping over 11% [1][5]. - The Hong Kong innovative drug ETF (520880) experienced a decline of 2.25%, losing all moving averages, with a trading volume of 3.69 billion [1][5]. Group 3: Innovative Drug Sector Insights - The innovative drug sector, despite entering a phase of adjustment since September, continues to attract significant investor interest, with the Hong Kong innovative drug ETF (520880) raising over 675 million in the last 20 days [5][7]. - Analysts suggest that the innovative drug sector may see renewed opportunities in Q4, driven by upcoming academic conferences and policy implementations that could support domestic innovation [7]. Group 4: Investment Strategies - Investment strategies in the medical sector are focusing on two main lines: identifying companies with strong Q3 performance and exploring opportunities in innovative drugs for potential rebounds [7]. - The fund manager of the Hong Kong innovative drug ETF (520880) emphasizes the importance of balancing investments within the sector, including medical devices and services that may gain market attention [7].

公司名稱： 諾誠健華醫藥有限公司（於開曼群島註冊成立的有限公司） 呈交日期： 2025年10月10日 FF305 翌日披露報表 (股份發行人 ── 已發行股份或庫存股份變動、股份購回及/或在場内出售庫存股份) 表格類別： 股票 狀態： 新提交 如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司（「香港聯交所」）證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露，必須填妥第一章節 。 | 第一章節 | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 | 是 | | | 證券代號 (如上市) | 09969 | 說明 | | | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | | | | 已發行股份（不包括庫存股份）變動 | | 庫存股份變動 | | | | 事件 | | 已發行股份（不包 ...