FF301 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年5月31日 狀態: 新提交 致：香港交易及結算所有限公司 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6月4日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 09969 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 25,000,000,000 | USD | 0.000002 | USD | | 50,000 | | 增加 / 減少 (-) | | | | | | USD | | | | 本月底結存 | | | 25,000,000,000 | USD | 0.000002 | USD | | 50,000 | 本月底法 ...

Core Insights - Chronic Lymphocytic Leukemia (CLL) is increasingly prevalent among the aging population in China, with a median age of diagnosis at 65 years, and the patient count is expected to grow at an annual rate of over 10% in the next decade [3] - The approval of multiple BTK inhibitors for first-line treatment of CLL marks a significant shift in therapy, moving away from traditional chemotherapy, which has considerable side effects and is less suitable for older patients [1][4] - The introduction of oral BTK inhibitors, such as Orelabrutinib, enhances patient compliance and offers a more manageable treatment option, although monitoring for adverse effects remains essential [4][5] Industry Overview - As of now, five BTK inhibitors have been approved in China for CLL treatment, including three imported drugs and two domestic ones, indicating a growing market for targeted therapies [1][3] - The challenges in CLL treatment include the concentration of quality medical resources in major cities, weak capabilities in grassroots healthcare, and the need for standardized treatment protocols [3] - The future direction of CLL treatment is leaning towards "chemotherapy-free" strategies, with ongoing developments in new drugs and combination therapies expected to refine treatment options [5]

Investment Rating - The report assigns a "Buy" rating to several companies in the pharmaceutical sector, indicating a potential upside of over 15% in their stock prices over the next 12 months [31]. Core Insights - The MSCI China Healthcare Index has increased by 27.6% since the beginning of 2025, outperforming the MSCI China Index by 14.5% [2]. - The international competitiveness of Chinese innovative drugs is being demonstrated through significant overseas licensing deals, reflecting a strong market presence [2]. - The report anticipates a valuation recovery in the pharmaceutical industry by 2025, driven by factors such as overseas licensing transactions, optimization of domestic procurement policies, and the implementation of new medical insurance categories [5]. Summary by Sections 1. **Industry Research - Medical Insurance Negotiations** - Continued support for innovation and recovery in overseas R&D demand [5]. 2. **Industry Research - Medical Equipment** - Expected recovery in bidding for medical devices and fruitful outcomes from innovative drug overseas transactions [5]. 3. **Industry Research - Medical Insurance Directory** - The results of adjustments to the medical insurance directory are expected to continuously support innovation [5]. 4. **Industry Research - Ongoing Policy Efforts** - Positive outlook for valuation rebound due to sustained policy support [5]. 5. **Industry Research - New Medical Insurance Categories** - The introduction of new medical insurance categories is expected to open up domestic payment space for innovative drugs [5]. 6. **Industry Research - Valuation Recovery** - The industry is poised for a valuation recovery, with several companies recommended for purchase [5]. 7. **Industry Research - Drug Pricing Policies** - Drug pricing policies are expected to be optimized, with accelerated commercialization of medical AI [5]. 8. **Industry Research - Anticipated Drug Procurement Policy Optimization** - Expectations for the implementation of an "innovative drug directory" [5]. 9. **Industry Research - 2024 Performance Review** - Innovative drugs are expected to dominate the market [5].

Group 1 - The Hang Seng Biotechnology ETF (159615) opened with a gap up, rising over 4% during the day, reaching a high of 1.008 yuan, marking a new high for the year [1] - The fund saw a turnover of 18.97% with a transaction volume of 61.0632 million yuan, indicating active market trading [1] - The Hang Seng Biotechnology Index surged by 3.83%, with constituent stocks such as Innovent Biologics rising over 16%, Zai Lab increasing by 7.66%, and Tigermed up by 6.42% [1] Group 2 - The National Medical Products Administration recently approved 11 new drugs for market launch, covering areas such as oncology and endocrinology, with several being the "first in China" or "first domestic" in their respective fields [1] - Among the 11 new drugs, 7 are classified as Category 1 drugs, representing the highest level of drug innovation in China's registration classification [1] - Guotai Junan Securities reported that the number of oral presentations for Chinese innovative drug assets at ASCO reached a historical high of 73, reflecting the growing demand for Chinese innovative drug assets from multinational corporations [2] Group 3 - The Hang Seng Biotechnology Index aims to reflect the overall performance of the largest 50 biotechnology companies listed in Hong Kong, with the top ten weighted stocks including Innovent Biologics, WuXi Biologics, BeiGene, and others [2]

Group 1 - The core viewpoint of the news highlights significant advancements in the biotech sector, particularly focusing on the performance of companies like Innovent Biologics and Hansoh Pharmaceutical, driven by clinical trial results and strategic partnerships [1][2]. - Innovent Biologics reported promising Phase I clinical trial data for its first-in-class PD-1/IL-2α-bias bispecific antibody IBI363, showing controllable safety and encouraging efficacy in treating advanced non-small cell lung cancer [1]. - Morgan Stanley raised the target price for Innovent Biologics from HKD 55 to HKD 74, reflecting increased confidence in its pipeline, particularly IBI363 and IBI343, maintaining an "overweight" rating [1]. Group 2 - Hansoh Pharmaceutical entered a licensing agreement with Regeneron, granting global exclusive rights (excluding mainland China, Hong Kong, and Macau) for the development and commercialization of HS-20094, with an upfront payment of USD 80 million and potential milestone payments of up to USD 1.93 billion [2]. - The pharmaceutical industry is expected to experience valuation recovery in 2025, driven by factors such as innovative drug exports, optimization of domestic procurement policies, and the implementation of new medical insurance directories [2]. - The Hong Kong Medical ETF (513700) is recommended for investors looking to capitalize on the long-term growth of the Hong Kong pharmaceutical sector, as it effectively tracks the performance of the industry [2]. Group 3 - As of May 30, 2025, the top ten weighted stocks in the CSI Hong Kong Stock Connect Pharmaceutical and Healthcare Index accounted for 60.77% of the index, including companies like BeiGene, WuXi Biologics, and Innovent Biologics [3].

Core Viewpoint - The Hong Kong stock market is expected to open higher, with a positive pre-market performance in the innovative drug sector, driven by significant approvals for new drugs in China [1] Group 1: Market Performance - The Hong Kong innovative drug index constituents saw notable gains, with Innovent Biologics rising over 6%, and other companies like Zai Lab and WuXi AppTec increasing by over 2% [1] - The Hong Kong innovative drug ETF (159567) experienced a net inflow of over 165 million yuan in the past 20 trading days, indicating high market enthusiasm [1] - The price-to-earnings ratio of the Hong Kong innovative drug index decreased from 64 times on February 21 to 27 times on June 4, highlighting improved value for investors [1] Group 2: Regulatory Developments - On May 29, the National Medical Products Administration of China approved 11 innovative drugs, including 7 first-class innovative drugs, marking a historic moment for the sector [1] - Over 20 first-class innovative drugs have been approved from January to May, setting a record for the same period in the past five years [1] - The Chinese pharmaceutical industry is transitioning from "follow-up innovation" to "global leadership," focusing on clinical value in key areas like targeted cancer therapies and immunotherapy [1] Group 3: Investment Opportunities - The innovative drug ETF (159567) tracks the National Index of Hong Kong Innovative Drugs, with 90% of its weight in innovative drug companies, positioning it to benefit from trends like AI-enabled drug development and the expansion of domestic innovative drugs [1] - The innovative drug ETF (159992) encompasses leading companies in the innovative drug industry chain, benefiting from AI advancements and the introduction of new drug reimbursement policies [2] - The domestic innovative drug sector is expected to show strong growth and investment value in the first half of 2025, driven by ongoing international collaborations and the approval of new drugs [2]

Core Viewpoint - In May 2025, over 70% of the 8,451 comparable mixed funds experienced net value increases, indicating a positive trend in the market [1] Fund Performance Summary - A total of 54 mixed funds achieved a monthly increase of over 10%, with Jinxin Value Selected Mixed A and C leading at 19.38% and 19.36% respectively [2] - Jinxin Value Selected Mixed A and C, established on September 1, 2017, reported year-to-date returns of 32.65% and 32.60%, and cumulative returns of 48.85% and 49.57% as of May 30, 2025 [2] - The top ten holdings of Jinxin Value Selected Mixed A and C focus on the pharmaceutical and biotechnology sectors, particularly in innovative industries [2] - Huabao Pharmaceutical and Biological Mixed A achieved a monthly increase of 11.49%, with a year-to-date return of 41.55% and a cumulative return of 381.22% since its inception [3] Fund Decline Summary - 15 mixed funds saw declines exceeding 10% in May, with Furong Fuxin Mixed C and A at the bottom with -12.39% and -12.38% respectively [4] - Furong Fuxin Mixed C and A focus on humanoid robotics, with their top holdings including Huachen Equipment and Qinchuan Machine Tool [4] Fund Manager Insights - The current fund manager for Jinxin Value Selected Mixed A and C is Zhao Haoran, who has a background in financial research and joined Jinxin Fund in August 2022 [2] - Huabao Pharmaceutical and Biological Mixed A is managed by Zhang Jintao, who has extensive experience in investment research across various financial institutions [3] - Furong Fuxin Mixed C and A are co-managed by Li Yanzheng and Mao Yunhong, both of whom have significant experience in research and fund management [4]

Group 1 - The core viewpoint of the news is the performance and holdings of the Huatai Fuhua Medical Service Flexible Allocation Mixed A Fund, which has shown significant growth in recent months and year-to-date [1] - As of June 3, 2025, the fund's latest net value is 1.7160 yuan, reflecting a growth of 1.42% [1] - The fund's performance over the past month has yielded a return of 8.74%, ranking 25 out of 2343 in its category; over the past three months, it has achieved a return of 31.37%, ranking 3 out of 2331; and year-to-date, it has returned 40.53%, ranking 8 out of 2318 [1] Group 2 - The top ten stock holdings of the fund account for a total of 64.17%, with significant positions in companies such as Heng Rui Pharmaceutical (10.23%), Kelun Pharmaceutical (9.09%), and Bai Li Tianheng (8.94%) [1] - The fund was established on June 18, 2015, and as of March 31, 2025, it has a total asset size of 4.408 billion yuan [1] - The fund manager, Zhang Wei, has extensive experience in the pharmaceutical sector, having held various positions in research and fund management since 2021 [2]

Core Viewpoint - The investment landscape for innovative drugs in 2025 is expected to be clear and profitable, particularly for those with overseas market potential, but selecting stocks will be challenging due to market sentiment and rapid shifts in hot sectors [2]. Group 1: Market Performance - Over 50 stocks have increased by more than 30% this year, with around 30 of these related to innovative drugs, indicating a strong correlation between stock performance and the innovative drug sector [3]. - Innovative drug assets, with clear labeling, have an average increase of 50%, with a median increase of 35% [4]. Group 2: High-Elasticity Stocks and Their Logic - Stocks like Shuyatong and Yipanghong have seen significant price increases due to their innovative drug targets and clinical progress, with Shuyatong's stock rising fourfold in two months [5][6]. - Sanofi's PD-1/VEGF dual antibody has doubled its market value due to a lucrative deal, showcasing the impact of strategic partnerships on stock performance [6]. - Yifang Bio's stock surged by 150% following positive clinical data, highlighting the importance of clinical trial results in driving stock prices [7]. - Stocks like Hot Scene Bio and Rongchang Bio have experienced substantial increases due to market sentiment and clinical data releases, with increases of 300% and 130% respectively [7][8]. Group 3: Characteristics of Innovative Drug Market - Stocks that have significantly outperformed typically have either strong clinical data or are widely recognized drugs, such as Yipanghong's gout medication and Taienkang's vitiligo treatment [10]. - The current market phase is characterized by a focus on pipeline exploration, with investors looking for promising clinical-stage products [13]. Group 4: Future Market Trends - Key events to watch for in the innovative drug sector include business development (BD) transactions, important data releases from clinical trials, and the potential for overvaluation leading to market corrections [15].

Investment Rating - The investment rating for the pharmaceutical industry is "Recommended" (maintained) [1] Core Insights - Significant transactions are driving the revaluation of innovation value in the pharmaceutical sector, with notable deals such as a $60 billion transaction by 3SBio and a $50 billion forecasted deal by CSPC Pharmaceutical Group [3] - The 2025 ASCO conference highlighted ADC, bispecific antibodies, and tri-specific antibodies as key areas of focus, with promising clinical results reported by Chinese companies [4] - Chinese innovative pharmaceutical companies are leading breakthroughs in CAR-T technology, with significant advancements expected in 2025 [6] - The gout treatment market presents substantial potential, with a projected increase in patients in China from 170 million in 2020 to 240 million by 2030 [8] - The oral weight loss drug market is seeing increased activity from leading companies, with notable collaborations and clinical advancements [10] - The approval of the world's first flu RNA polymerase PB2 protein inhibitor offers new treatment options for flu resistance [12] Summary by Sections 1. Pharmaceutical Market Tracking - The pharmaceutical industry outperformed the CSI 300 index by 2.21% over the past week, with a weekly increase of 3.30% [28] - Over the past month, the industry also outperformed the CSI 300 index by 4.57%, with a monthly increase of 6.42% [31] 2. Pharmaceutical Sector Trends and Valuation - The pharmaceutical sector's current PE (TTM) is 34.03, slightly above the five-year historical average of 32.54 [45] 3. Recent Research Achievements - Recent reports highlight the steady growth of blood products and the acceleration of the import substitution process in inhalation preparations [48] 4. Recent Industry Policies and News - The State Council announced a reduction in tariffs on imports from the U.S., which may impact the pharmaceutical sector [51] - Several innovative drugs have received approval for clinical trials and market entry, indicating a robust pipeline for the industry [52][53] 5. Recommended Companies and Earnings Forecast - Companies recommended for investment include Changchun High & New Technology, Yifan Biotech, and Zhongsheng Pharmaceutical, among others, with a focus on areas such as gout treatment and CAR-T technology [14]