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6月30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7月3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 | II. ...

Financial Performance - The company achieved total revenue of 381 million RMB in Q1 2025, a 129.92% year-over-year increase[9] - Sales revenue from Orelabrutinib reached 311 million RMB, an 89.22% year-over-year increase[9] - The company reported a net profit of 14 million RMB in Q1 2025[9] - Gross profit margin reached 90.5%, a 5.1 percentage point increase compared to the same period last year[9] - The company holds a strong cash reserve of 7800 million RMB[9] Orelabrutinib (BTK Inhibitor) - Orelabrutinib was approved in China for 1L CLL/SLL[9] - NDA submissions for multiple indications of Orelabrutinib are underway overseas[9] - Orelabrutinib is recommended in the 2025 CSCO lymphoma guidelines for CLL/SLL, MZL and MCL[20, 21] Pipeline Progress - Tafasitamab BLA for r/r DLBCL was accepted and granted priority review in mainland China[9] - Zurletrectinib NDA was submitted at the end of March 2025 and granted priority review[9] - A Phase III registrational clinical trial of Mesutoclax in combination with Orelabrutinib for 1L CLL/SLL is ongoing[9] Strategic Collaborations - Prolium Bioscience will gain rights to develop, register, produce, and commercialize ICP-B02 globally in non-oncology fields and in oncology fields outside of Asia[15] Autoimmune Disease - Phase III registrational clinical trials for Orelabrutinib in PPMS and SPMS are expected to enroll the first patient in the second half of 2025[9] - A Phase III registrational clinical trial for Orelabrutinib in ITP is expected to submit an NDA in the first half of 2026[9] - A Phase IIb trial for Orelabrutinib in SLE has completed patient enrollment, with data readout expected in Q4 2025[9]

Company Overview - InnoCare aims to become a global biopharmaceutical leader, focusing on oncology and autoimmune diseases[6, 7, 8] - The company has raised a total of $134 billion USD since its founding in 2015[11] - InnoCare has a fully-integrated drug innovation platform with 13 clinical products in the pipeline and 2 marketed products[13] Orelabrutinib (BTKi) - Orelabrutinib demonstrates ~100% BTK occupation at 50 mg QD and above, with an improved safety profile[23] - Orelabrutinib has shown an 83% overall response rate (ORR) in r/r MCL patients and a 589% ORR in r/r MZL patients[34] - A Phase III registrational trial for Orelabrutinib is ongoing in China for SLE[52] ICP-332 (TYK2 Inhibitor) - ICP-332, at 80mg QD, achieved a 782% reduction from baseline in EASI score in Atopic Dermatitis (AD) patients[75] - 88% of patients achieved EASI 50 and 72% achieved EASI 75 at Week 4 with ICP-332 treatment[75] - Global AD market is expected to reach $222 billion USD by 2028[71] Portfolio Expansion - Tafasitamab BLA submission in China is planned for 2024Q2, targeting 160,000 new DLBCL patients globally per annum[46] - ICP-248 (BCL-2 inhibitor) showed 100% efficacy (6 out of 6 patients) in early clinical results[41] - InnoCare plans to submit an NDA for 1L CLL/SLL in China and r/r MCL in the USA for Orelabrutinib in the second half of 2024[102]

Core Viewpoint - The Hong Kong innovative drug sector has experienced significant growth in the first half of 2025, driven by policy support, industry catalysts, and market sentiment, leading to outstanding performance of actively managed equity funds focused on this sector [1][2]. Group 1: Fund Performance - Several actively managed funds, including Huatai-PineBridge Hong Kong Advantage Selection A, achieved returns exceeding 60%, with Huatai-PineBridge leading at 85.64% as of June 27 [1][2]. - The top holdings of these funds saw substantial gains, with Rongchang Bio rising 278% and other companies like Innovent Biologics and Kelun-Biotech also exceeding 100% in growth [1]. - ETFs tracking the Hong Kong pharmaceutical sector also performed well, with the top ETF, Huatai-PineBridge National Index Hong Kong Innovative Drugs ETF, seeing a net inflow of over 6 billion yuan, increasing its size from 653 million yuan to over 7.8 billion yuan [2]. Group 2: Market Dynamics - The innovative drug sector is currently in a high valuation range, with some institutions suggesting that short-term speculative trading may lead to profit-taking and potential stock price adjustments [3]. - The market has seen a resonance between market liquidity and industry logic, with multinational corporations (MNCs) driving significant business development (BD) in innovative drug companies [2][3]. - Recent policy measures announced on June 30 aim to support the high-quality development of innovative drugs, enhancing R&D support and facilitating market access [4]. Group 3: Future Outlook - The new policy framework is expected to enhance the certainty of R&D in innovative drugs and accelerate commercialization cycles, providing further support for sector valuations [4]. - Investment opportunities are anticipated in product-oriented companies, particularly those focusing on global market expansion and innovative breakthroughs [4][5]. - The Chinese innovative drug industry is at a critical turning point, with ADC and bispecific antibody technologies expected to capture significant market share in global immunotherapy, although caution is advised regarding competition and the role of AI in drug development [5].

Investment Rating - The investment rating for InnoCare Pharma (H share) is "Buy" with a 12-month target price of HK$12.72, indicating a downside potential of 7.6% from the current price of HK$13.76 [8][9]. Core Insights - InnoCare Pharma is on track for commercial progress, with management guiding for one major business development (BD) deal in the second half of 2025 [1][2]. - The company expects peak sales of over US$1 billion for orelabrutinib in China, driven by various indications including hematologic cancers, immune thrombocytopenic purpura (ITP), and systemic lupus erythematosus (SLE) [6][8]. - Upcoming data readouts over the next 12 months include phase 2b data for orelabrutinib on SLE and phase 3 data for ICP-488 on psoriasis [7]. Summary by Sections Business Development Focus - The management's priority for out-licensing will focus on immunology disease assets, particularly: 1. ICP-332, which has shown promising phase 2 data for atopic dermatitis and is also being studied for vitiligo and prurigo nodularis [2]. 2. ICP-488, with accelerated patient enrollment for phase 3 trials on psoriasis [2]. 3. Orelabrutinib, with global trials planned for primary progressive multiple sclerosis (PPMS) and secondary progressive multiple sclerosis (SPMS) [2]. Commercialization Progress - The company reported that commercial execution in Q2 was on track, with a year-on-year growth expectation of over 35% for orelabrutinib [3]. Financial Projections - Revenue projections for InnoCare Pharma indicate growth from Rmb1,009.4 million in 2024 to Rmb2,717.9 million by 2027, with EBITDA improving from a loss of Rmb547.3 million in 2024 to a profit of Rmb194.4 million in 2027 [9].

Core Insights - The core viewpoint of the news is the performance and holdings of the Industrial and Commercial Bank of China (ICBC) Healthcare Stock Fund, highlighting its recent net value, returns, and top holdings [1]. Fund Performance - The latest net value of ICBC Healthcare Stock Fund is 2.5760 yuan, reflecting a growth of 1.18% - The fund's return over the past month is -0.46%, ranking 514 out of 1026 in its category - Over the last six months, the fund has achieved a return of 11.85%, ranking 173 out of 993 - Year-to-date, the fund has returned 13.03%, ranking 137 out of 997 [1]. Fund Holdings - The top ten holdings of the ICBC Healthcare Stock Fund account for a total of 39.79%, with the following key positions: - Heng Rui Medicine: 8.90% - WuXi AppTec: 5.12% - Aier Eye Hospital: 4.94% - BeiGene: 3.77% - Zai Lab: 3.52% - New Horizon Health: 3.27% - Mindray Medical: 2.80% - Yuyue Medical: 2.76% - United Imaging Healthcare: 2.47% - Innovent Biologics: 2.24% [1]. Fund Management - The ICBC Healthcare Stock Fund was established on November 18, 2014, and as of March 31, 2025, it has a total scale of 2.724 billion yuan - The fund is managed by Zhao Bei and Ding Yang, with Zhao having extensive experience in healthcare research and fund management [2].

Group 1 - Jisong Cui continues to serve as an executive director, approved by the shareholders' meeting on June 21 [1] - Jisong Cui holds multiple positions in the company, including chairperson of the board, CEO, and key technical personnel [2] - Jisong Cui has over 20 years of experience in pharmaceutical research and company management, having held significant roles in various organizations [3] Group 2 - The company has a total of 9 directors and senior management personnel, excluding independent directors and the chairman of the supervisory board [4] - The average age of the board and senior management is 54 years, with a median age of 57 years; Jisong Cui is the oldest at 63 years [4] - Jisong Cui's compensation for 2024 is reported at 0.0163 million, with no comparative increase or decrease mentioned [4]

Investment Rating - The industry investment rating is "Positive" (maintained) [1] Core Insights - The report highlights recent positive developments in the high-quality weight loss sector, particularly focusing on myostatin pathway clinical trial results from Regeneron and Scholar Rock, which demonstrate significant reductions in lean body mass loss when combined with GLP-1 medications [4][12] - The pharmaceutical and biotechnology sector experienced a decline of 4.35% in the third week of June 2025, underperforming the CSI 300 index by 3.9 percentage points, ranking 29th among 31 sub-industries [5][16] - The report emphasizes the potential of Activin receptor drugs, such as Eli Lilly's Bimagrumab and Lai Kai's LAE-102, to retain lean body mass and even promote muscle gain, with promising safety and pharmacokinetic data [4][12] Summary by Sections 1. Recent Developments in Weight Loss Sector - Regeneron's myostatin antibody Trevogrumab combined with semaglutide showed a 50.8% reduction in lean body mass loss over 24 weeks, compared to a 7.9 lbs loss with semaglutide alone [4][12] - Scholar Rock's myostatin antibody Apitegromab combined with Tirzepatide demonstrated a 54.9% reduction in lean body mass loss [4][12] 2. Market Performance - The pharmaceutical and biotechnology sector's decline of 4.35% in June's third week was the largest among all sectors, with the vaccine sector experiencing the smallest drop of 0.4% [5][21] - Other sub-sectors, such as blood products and medical consumables, also faced declines, with the largest drop seen in other biological products at 6.7% [5][21] 3. Recommended Stocks - Recommended stocks include major pharmaceutical and biotechnology companies such as Heng Rui Medicine, East China Medicine, and Innovent Biologics, among others [6]

Investment Rating - The report maintains an "Overweight" rating for the pharmaceutical industry, indicating a positive outlook for the sector compared to the overall market performance [23]. Core Insights - The pharmaceutical sector experienced a decline of 4.4% this week, underperforming the Shanghai Composite Index, which fell by 0.5% [2][3]. - The overall valuation of the pharmaceutical sector stands at 28.7 times PE (2025E), ranking it 5th among 31 sub-industries [5][10]. - Recent policies from the National Medical Products Administration (NMPA) aim to support the development of high-end medical devices and accelerate the clinical review process for innovative drugs [12]. - Shengnuo Biopharma forecasts a significant profit increase for H1 2025, with expected net profit ranging from 77.03 million to 94.14 million yuan, marking a year-on-year growth of 253.54% to 332.10% [13]. Market Performance - The pharmaceutical and biotechnology index ranked 29th out of 31 sub-industries this week, with various segments showing declines, including chemical preparations (-5.7%) and medical devices (-3.7%) [2][5]. - The report highlights the strong growth in product revenue and licensing deals in the innovative drug sector over the past three years, with a focus on companies expected to release major products and those involved in the CXO industry [12]. Key Events - The NMPA has approved measures to encourage the innovation of high-end medical devices, including optimizing special approval processes and enhancing regulatory frameworks [12]. - The NMPA has also proposed a 30-day review process for clinical trial applications of innovative drugs, aimed at improving the efficiency of drug development [12].

Core Viewpoint - The innovative drug sector has rebounded significantly within six months, indicating a completed valuation repair and a shift towards event-driven phases in business development and clinical trials [3][4]. Group 1: Market Dynamics - The price-to-sales ratio (PS) for innovative drugs is currently at 14 times, close to the five-year average, suggesting a recovery in valuations [3]. - The Hong Kong market has become a primary venue for innovative drugs and new consumer products, with 28 new listings raising HKD 77.36 billion in the first five months of the year, a 707% increase year-on-year [7]. - Southbound capital has been a major force in driving up the stock prices of innovative drugs and new consumer sectors, with net inflows of HKD 55.14 billion and HKD 18.32 billion respectively throughout the year [9]. Group 2: Investment Sentiment - The innovative drug sector is experiencing a bubble, characterized by unrealistic expectations for companies lacking overseas expansion plans or self-research capabilities [3][4]. - Despite the risks associated with bubbles, they can stimulate investment in the sector, as the original innovation capabilities are strengthening, with China leading in the number of research pipelines [4][5]. - The trading congestion in the innovative drug sector has reached a high point, with trading volume nearing 4.8%, indicating a potentially overheated market [11]. Group 3: Future Outlook - The Chinese market is expected to see a surge in innovative drug supply, driven by regulatory changes that expedite clinical trial reviews, with timelines reduced from 60 days to 30 days for certain drugs [16]. - The potential for large business development (BD) opportunities in the second half of the year is significant, with a focus on companies that have demonstrated strong BD capabilities in the past [28]. - The innovative drug sector is projected to continue its growth trajectory, with major academic conferences scheduled for the latter half of the year, which will likely showcase new clinical data and further stimulate interest [28].