Investment Rating - The report maintains an investment rating of "Outperform the Market - A" [6] Core Insights - The report highlights the promising clinical data of BaiLi Tianheng's EGFR/HER3 dual antibody ADC, iza-bren, for treating EGFR mutation lung cancer, which shows potential for further clinical advancement [2][3][20][21][23] Summary by Sections Weekly New Drug Market Review - From September 8 to September 14, 2025, the top five gainers in the new drug sector were: - Saintno Pharmaceutical (+32.00%) - Junshengtai (+23.73%) - Canaan Bio (+20.43%) - Rongchang Bio (+16.52%) - Hengrui Medicine (+11.91%) - The top five losers were: - Basestone Pharmaceuticals (-18.90%) - Laika Pharmaceuticals (-18.12%) - Gilead Sciences (-16.93%) - Maiwei Bio (-14.41%) - Yifang Bio (-12.46%) [1][15] Recommended Stocks to Watch - The report suggests focusing on several potential catalysts in the sector, including academic conferences, business development realizations, and insurance negotiations. Key stocks to watch include: 1. Potential overseas licensed MNC heavyweights: - Differentiated GLP-1 assets: Zhongsheng Pharmaceutical, Gilead Sciences, Borui Pharmaceutical, Kangyuan Pharmaceutical - Upgraded PD-1 products: Kangfang Bio and other PD-1/VEGF assets, Innovent Biologics - Breakthroughs in autoimmune fields: Yifang Bio, China Antibody - Innovative target ADCs: Fuhong Hanlin, Shiyao Group 2. MNC-certified products with high overseas volume certainty: - Upgraded PD-1 products: Sanofi Pharmaceutical - GLP-1 assets: Lianbang Pharmaceutical - ADC assets: Kelong Botai, BaiLi Tianheng 3. Products likely to benefit from insurance negotiations and innovative drug directories [2][20] New Drug Industry Focus Analysis - At the recent 2025 World Lung Cancer Conference (WCLC), BaiLi Tianheng presented results from two studies on its EGFR×HER3 dual antibody ADC, iza-bren, showing excellent clinical data in both first-line and second-line treatments for advanced or metastatic EGFR mutation NSCLC. The results indicate a promising future for its application in relevant indications [2][20][21] New Drug Approval and Acceptance Status - No new drug or new indication applications were approved this week, but seven new drug or new indication applications were accepted [3][25] Clinical Application Approval and Acceptance Status - This week, 41 new drug clinical applications were approved, and 46 new drug clinical applications were accepted [9][28]

Group 1 - Company Gilead Sciences-B (01672) announced the issuance of 421 shares on September 12, 2025, due to eligible participants exercising stock options under the stock option plan adopted on June 6, 2019 [1] - The issuance price for each share is set at HKD 2.9 [1]

Core Viewpoint - The company, Gilead Sciences-B (01672), announced the issuance of 421 shares at a price of HKD 2.9 per share due to eligible participants exercising stock options under the stock option plan adopted on June 6, 2019 [1] Group 1 - The issuance date for the new shares is set for September 12, 2025 [1] - The stock option plan was initially adopted on June 6, 2019 [1]

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 公司名稱： 歌禮製藥有限公司 呈交日期： 2025年9月12日 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 。 FF305 第 2 頁 共 6 頁 v 1.3.0 FF305 確認 根據《主板上市規則》第13.25C條 / 《GEM上市規則》第17.27C條，我們在此確認，據我們所知所信，第一章節所述的每項股份發行或庫存股份出售或轉讓已獲發行人董事會正式授權批准，並遵 照所有適用上市規則、法律及其他監管規定進行，並在適用的情況下： | 第一章節 | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | ...

Core Viewpoint - The article highlights the successful development of ASC30, a long-acting subcutaneous formulation of a small molecule GLP-1 receptor agonist by the company, which shows promise for quarterly dosing in obesity management, addressing an unmet need in long-term weight management [2][5]. Group 1: Product Development - ASC30 is the first and currently the only investigational small molecule GLP-1 receptor agonist that can be developed as an oral tablet taken once daily or a subcutaneous formulation administered monthly or quarterly [5]. - The clinical study in the U.S. demonstrated a 75-day half-life for ASC30, indicating its potential for less frequent dosing [2]. - The treatment showed good tolerability with only mild gastrointestinal reactions, which may enhance patient compliance and quality of life [2]. Group 2: Company Overview - The company focuses on innovative therapies for chronic diseases, particularly in the development of small molecule drugs aimed at sustainable weight control [6]. - ASC30 is a new chemical entity (NCE) with compound patent protection in the U.S. and globally until 2044, excluding any patent extensions [5].

Core Viewpoint - The stock of Gilead Sciences-B (01672) rose over 5% in early trading, driven by the announcement of a voluntary lock-up commitment from the controlling shareholder, which will prevent the sale of shares until key clinical data is released [1] Group 1: Clinical Trials and Data - Gilead Sciences announced that the controlling shareholder will not sell any company shares before the release of three key clinical data points: 1. Top-line data from the U.S. Phase I clinical trial of ASC47 combined with semaglutide in obese subjects, expected by the end of September 2025 2. Top-line data from the U.S. 13-week Phase IIa clinical trial of ASC30 oral tablets in obese or overweight subjects, expected by December 2025 3. Top-line data from the U.S. Phase I single ascending dose study of ASC50 in healthy subjects, expected by December 2025 [1][1][1] Group 2: Drug Development and Potential - The company recently announced that the small molecule GLP-1R agonist ASC30 demonstrated an apparent half-life of 75 days in obese subjects, indicating the potential for developing a long-term weight management solution with quarterly dosing [1][1] - ASC30 is developed using Gilead's Ultra-Long-Acting Drug Development Platform (ULAP), and the company has multiple pipelines relying on this platform to develop long-acting formulations, which may meet various clinical needs [1][1]

Core Viewpoint - The stock of Gilead Sciences-B (01672) rose over 5% in early trading, currently up 3.95% at HKD 11.85, with a trading volume of HKD 36.6973 million, following the announcement of a voluntary lock-up commitment by the controlling shareholder before key clinical data releases [1] Group 1: Clinical Trials and Data Releases - The controlling shareholder has committed not to sell any shares before the release of three key clinical data points: 1. Topline data from the U.S. Phase I clinical study of ASC47 combined with semaglutide in obese subjects, expected by the end of September 2025 2. Topline data from the U.S. 13-week Phase IIa clinical study of ASC30 oral tablets in obese or overweight subjects, expected by December 2025 3. Topline data from the U.S. Phase I single ascending dose study of ASC50 in healthy subjects, expected by December 2025 [1][1][1] Group 2: Drug Development and Potential - The company recently announced that the small molecule GLP-1R agonist ASC30 has shown an apparent half-life of 75 days in obese subjects, indicating the potential for developing a long-term weight management solution with quarterly dosing [1][1] - ASC30 is developed using the company's ultra-long-acting drug development platform (ULAP), and the company has multiple pipelines relying on this platform to develop long-acting formulations, which may meet various clinical needs [1][1]

Core Viewpoint - The article discusses the resilience of the innovative drug sector in the face of negative news and highlights the long-term investment opportunities despite short-term volatility [3][4][9]. Group 1: Market Performance - On September 10, both the A-share and Hong Kong innovative drug sectors opened significantly lower due to negative external news, but many stocks rebounded during the day, demonstrating the sector's resilience [3][4]. - The innovative drug ETF in the A-share market initially dropped over 5.7% but closed down only 0.51%, indicating a recovery [4]. - The total revenue of 39 Hong Kong innovative drug companies reached 152.06 billion yuan in the first half of 2025, a year-on-year increase of 7.66%, with net profit increasing by 54.37% to 28.27 billion yuan [7]. Group 2: Policy Impact and Industry Dynamics - The negative sentiment was triggered by reports of the Trump administration drafting an executive order to impose strict restrictions on Chinese drugs, particularly laboratory drugs [4][6]. - Fund managers believe that the policy direction has already been anticipated and will not have a substantial new impact on the sector [3][4]. - The collaboration between multinational corporations (MNCs) and Chinese innovative drug companies remains strong, as MNCs benefit significantly from introducing Chinese innovations [5][6]. Group 3: Investment Opportunities - The current innovative drug market is driven by improved fundamentals rather than just capital influx, with many companies entering a phase of profit growth [7][9]. - The article suggests focusing on mid-to-large innovative drug companies that have already launched products and are contributing to earnings, as well as those with high certainty in business development [3][9]. - The long-term trend for innovative drugs is expected to continue, with the potential for significant market capitalization growth surpassing previous cycles [7][8]. Group 4: Short-term Risks and Strategies - Despite the resilience of the pharmaceutical sector, fund managers caution about short-term volatility risks due to high market indices and negative sentiment [8][9]. - Historical experience indicates that emotional pullbacks triggered by sudden events can present good buying opportunities [10].

Core Viewpoint - The innovation drug sector in both A-shares and Hong Kong stocks experienced a significant drop on September 10, primarily due to external media reports regarding potential restrictions from the Trump administration on Chinese pharmaceuticals. However, the sector demonstrated resilience with many stocks recovering during the day, indicating long-term investment opportunities despite short-term volatility [1][2]. Group 1: Market Reaction and Resilience - On September 10, the innovation drug sector opened sharply lower but showed strong recovery, with ETFs rebounding significantly after initial declines. For instance, an innovation drug ETF initially dropped over 5.7% but closed down only 0.51% [2]. - The Hang Seng pharmaceutical sector exhibited notable gains, with many funds recovering from early losses of over 8% to close within 2% down [2]. Group 2: Interpretation of External News - Fund managers believe that the reported policy changes from the U.S. government regarding drug imports from China are not new and will not have substantial impacts on the sector. The trend of Business Development (BD) collaborations between multinational corporations (MNCs) and Chinese innovation drug companies is expected to continue [2][3]. - The collaboration between MNCs and Chinese innovation drug firms is seen as a norm, with Chinese assets remaining globally competitive despite political noise [3]. Group 3: Fundamental Validation of Innovation Drugs - The innovation drug market has shown signs of fundamental improvement, with several companies, including Hengrui Medicine and BeiGene, expected to achieve revenue and profit growth in the first half of 2025. A report indicated that 39 Hong Kong innovation drug companies had a total revenue of 152.06 billion yuan (approximately $22.4 billion) in the first half of 2025, marking a 7.66% year-on-year increase [4]. - The underlying reasons for the current market trend include the recognition of efficient R&D and clinical innovation capabilities, which are expected to drive further market growth [4][5]. Group 4: Investment Outlook and Strategies - The investment outlook for innovation drugs is positive, with three main areas of focus: the profitability of Chinese innovation drug companies, the potential of AI in healthcare, and the valuation of leading companies in non-innovation drug sectors [5]. - Fund managers suggest that despite the recent market fluctuations, the long-term trend for innovation drugs remains upward, with a shift towards larger, more established companies that have already launched products and demonstrated performance [6]. Group 5: Short-term Risks and Opportunities - While the innovation drug sector shows resilience, there are warnings about potential short-term volatility due to market sentiment and policy uncertainties. Fund managers advise caution and suggest that recent price corrections may present good buying opportunities [6]. - Historical trends indicate that market reactions to sudden policy changes often create favorable conditions for investment, suggesting that current fluctuations could be leveraged for strategic positioning [6].

Core Viewpoint - The announcement from the company reflects a strong commitment to its long-term value and future prospects, as demonstrated by the voluntary shareholding commitment from key executives [1] Group 1: Shareholder Commitment - Dr. Wu Jinzi and He Jingdao have voluntarily committed not to sell or pledge any shares they control until the release of three key clinical trial data points [1] - The three clinical data readouts include: (i) top-line data from the U.S. Phase I clinical study of ASC47 combined with semaglutide, expected by the end of September 2025; (ii) top-line data from the U.S. 13-week Phase IIa clinical study of ASC30 oral tablets in overweight or obese subjects, expected by December 2025; and (iii) top-line data from the U.S. Phase I single ascending dose study of ASC50 in healthy subjects, also expected by December 2025 [1] - As of the announcement date, the total number of voluntarily locked-up shares held by Dr. Wu and his wife amounts to 576 million shares, representing approximately 58.03% of the company's existing issued share capital (excluding treasury shares) [1]