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，並明確表示概不就因本公告全部或任何部分內容而產生或因依賴 該等內容引致的任何損失承擔任何責任。 GenFleet Therapeutics (Shanghai) Inc. 勁方醫藥科技（上海）股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：2595） 自願公告 GFH375獲得國內首個KRAS G12D抑制劑治療 非小細胞肺癌的突破性療法認定 本公告由勁方醫藥科技（上海）股份有限公司（「本公司」或「勁方」，連同其附屬公 司統稱「本集團」）自願刊發，以知會本公司股東及潛在投資者有關本集團最新業 務動態。 關於GFH375/VS-7375 GFH375為口服高活性、高選擇性小分子KRAS G12D(ON/OFF)抑制劑，通過非共 價形式結合KRAS G12D蛋白，抑制其與下游效應蛋白結合，從而在細胞中破壞 KRAS G12D對下游通路的持續活化，最終高效抑制腫瘤細胞增殖。臨床前研究 已顯示GFH375單藥對腫瘤生長的抑制效應隨用藥劑量和週期增長而提升，且在 激酶選擇性和安全性靶點測試 ...

Core Viewpoint - The company is expected to achieve a product revenue of approximately 11.9 billion yuan in 2025, maintaining a strong year-on-year growth rate of about 45% [1] - In Q4, the company achieved a product revenue of around 3.3 billion yuan, with a year-on-year increase of over 60%, validating its strong product competitiveness and commercialization system [1] - The growth is driven by the sustained performance of existing products and rapid market entry of new products, with significant contributions from non-oncology areas [1] Event Summary - On February 4, the company announced its product revenue for 2025, projecting around 11.9 billion yuan for the year and approximately 3.3 billion yuan for Q4 [1] - The Q4 revenue was influenced by the inclusion of six new drugs in the national medical insurance catalog, which led to a one-time inventory adjustment [1] Business Performance - The company has expanded its oncology pipeline to 13 products, demonstrating increasing synergy effects [2] - The successful expansion into chronic disease areas has resulted in outstanding achievements, showcasing strong growth potential across its product line [2] - Key growth drivers include products like Sintilimab, Orelabrutinib, and Lembozole, along with rapid market entry of new products such as Masitinib and Tolebrutinib [1][2] Future Outlook - The company is expected to continue leveraging its core advantages and strategic foresight to drive development across multiple disease areas, aiming to become a leading global biopharmaceutical company [2] - The company has 17 commercialized drugs, with one product under NMPA review and four new drug candidates in Phase III or critical clinical studies, alongside 15 other candidates in clinical research [2] Financial Projections - The company is projected to achieve revenues of 11.968 billion yuan, 22.804 billion yuan, and 26.572 billion yuan for the years 2025, 2026, and 2027, respectively, with net profits of 0.886 billion yuan, 6.679 billion yuan, and 8.004 billion yuan [2] - Following a significant global strategic partnership with Takeda, the company retains 40% rights in the U.S. for IBI363, which is expected to enhance its internationalization efforts [2]

Core Insights - The introduction of new pricing for lung cancer drugs, particularly the KRAS G12C inhibitors, has significantly reduced costs for patients, with prices dropping by nearly 70% for some medications [2][4][7] - The 2025 medical insurance directory includes 50 innovative drugs, with nearly half being cancer treatments, highlighting a focus on unmet clinical needs [2] - The competitive landscape for KRAS G12C inhibitors is intensifying, with companies now competing on clinical efficacy and commercial execution rather than just pricing [5][7][8] Pricing and Market Impact - The price of Fluorouracil has decreased from approximately 24,900 yuan to 5,790.4 yuan per box, resulting in a 68.87% reduction [7] - Patients previously faced annual treatment costs of 223,200 yuan, which can now be reduced to approximately 20,845.44 yuan after insurance reimbursement, saving over 200,000 yuan annually [4] - The entry of these drugs into the insurance system is expected to reshape market dynamics and increase competition among pharmaceutical companies [4][8] Competitive Landscape - The KRAS G12C inhibitors market is characterized by three main products: Fluorouracil, Goresir, and Gexoriser, all approved for similar indications, creating a "three-legged" competitive structure [6] - The market for KRAS G12C inhibitors is not overly saturated, with the mutation occurring in about 14% of non-small cell lung cancer cases, and approximately 4.3% in the Chinese population [6] - Companies are focusing on differentiating their products through clinical evidence and effective management of side effects to establish a preferred choice among doctors and patients [7][8] Future Directions - Companies are exploring combination therapies and expanding indications beyond non-small cell lung cancer to other cancers like colorectal and pancreatic cancer, which may significantly increase market potential [13] - The focus on overcoming drug resistance and enhancing efficacy through partnerships and global market strategies is seen as essential for long-term success [13] - The competitive focus is shifting towards who can provide better clinical outcomes and safety profiles, indicating a new phase in the market dynamics for KRAS G12C inhibitors [7][8]

Core Insights - The success rate of negotiations for the National Essential Medicines List reached 88% in 2025, a significant increase from 76% the previous year, marking a seven-year high [1] - A total of 114 new drugs were added to the list, including 50 innovative first-class drugs, indicating a record number both in terms of proportion and quantity [2] - Nearly 100 drugs (98) were rejected during the formal review stage, with over 60% failing to pass expert evaluation, reflecting a continuous decline in the approval rate [1][4] Group 1: Negotiation Process and Outcomes - The negotiation process has matured over the past eight years, involving self-application by pharmaceutical companies, expert evaluations, and price negotiations, resulting in 718 submissions and 535 passing the formal review [2] - The expert evaluation phase saw a pass rate of 41.48%, with 129 drugs proceeding to negotiations, of which 112 were successfully included in the National Essential Medicines List [2] - The total number of drugs in the list increased to 3,253, with 1,857 Western medicines and 1,396 traditional Chinese medicines [8] Group 2: Reasons for Rejection - The decline in approval rates for drugs in the expert evaluation phase is attributed to increased clarity in application processes and heightened competition among similar drugs [4] - Several rejected drugs included first-class innovative drugs, with reasons such as lack of significant clinical value compared to existing treatments [5] - Four main reasons for rejection were identified: lack of innovation, high prices, and insufficient clinical necessity [6] Group 3: Support for True Innovation - The focus on "true innovation" emphasizes filling clinical gaps, offering superior alternatives, and providing better cost-effectiveness [7] - Successful new entries into the list included innovative treatments for various cancers and chronic diseases, reflecting a commitment to enhancing healthcare coverage [8] - The National Healthcare Security Administration aims to maintain a dynamic adjustment of the drug list to meet evolving clinical needs [8] Group 4: Value-Based Purchasing - The negotiation process incorporates a systematic value assessment, including expert evaluations and price calculations, to ensure fair pricing [9] - Recent improvements in price calculation methods aim to enhance fairness and scientific rigor in the evaluation process [10] - The emphasis on differentiated innovation requires pharmaceutical companies to provide substantial clinical evidence to support claims of added value [11]

Core Insights - The approval rate for drugs outside the national essential drug list has reached a four-year low during the expert review phase, indicating increasing scrutiny and higher standards for innovation [1][4] - The success rate for negotiations in the upcoming 2025 national essential drug list has improved to 88%, up from 76% the previous year, marking a seven-year high [1] - A total of 114 new drugs will be added to the national essential drug list, including 50 innovative first-class drugs, reflecting a significant increase in both quantity and quality [2][8] Group 1: Approval Rates and Trends - The approval rate for drugs in the expert review phase has declined for two consecutive years, with only 41.48% of drugs passing this stage this year [2][3] - In the past three years, the number of drugs passing the formal review has increased, but the expert review approval rate has decreased from 74.2% to 47.0% [3] - Nearly 60% of drugs outside the essential list failed to pass the expert review, highlighting a trend towards stricter evaluation criteria [1][4] Group 2: Reasons for Non-Approval - Several drugs, including first-class innovative drugs, were not approved due to lack of significant clinical value compared to existing treatments [5][6] - The "Four No Changes" principle (no change in active ingredient, indication, administration route, or clinical value) has been identified as a key reason for low approval rates [6] - High prices and mismatched value with existing treatments have also contributed to the rejection of certain drugs, with examples of significant price discrepancies noted [6] Group 3: Support for True Innovation - The national healthcare authority emphasizes support for "true innovation" and "differentiated innovation," aiming to exclude drugs that do not significantly advance clinical outcomes [5][7] - Successful drugs entering the essential list share common characteristics such as filling therapeutic gaps and offering superior alternatives [7] - The overall speed and quantity of innovative drugs entering the national essential drug list have increased, addressing various medical needs including major diseases and rare conditions [8] Group 4: Value-Based Pricing and Evaluation - The negotiation process for the national essential drug list has evolved to include a more systematic and scientific value assessment, enhancing fairness and rigor in price evaluations [10] - The approach to pricing has shifted to support higher payment thresholds for drugs with greater innovation, reflecting a value-based pricing model [10][11] - The importance of robust clinical evidence in supporting claims of additional benefits for new drugs has been highlighted, particularly in competitive therapeutic areas [11][12]

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 [2][29]. Core Insights - The release of the 2025 version of the basic medical insurance directory continues to support innovation, with 114 new drugs added, including 50 first-class innovative drugs, while 29 drugs were removed due to lack of supply or better alternatives [3]. - The MSCI China Healthcare Index has seen a cumulative increase of 60.9% since the beginning of 2025, outperforming the MSCI China Index by 29.2% [1]. - Despite a recent 9% pullback in the healthcare sector, undervalued stocks present attractive investment opportunities [1][3]. - The trend of innovative drugs going overseas is expected to continue, with a focus on the progress of these products in international markets [1]. - The demand for innovative drug research and development in China is showing signs of recovery, supported by a resurgence in capital market financing and an increase in the scale of overseas transactions [1]. Summary by Sections Industry Research - The report highlights that the adjustment of the medical insurance directory emphasizes support for "true innovation" and "differentiated innovation" [3]. - The first version of the commercial insurance directory includes 19 innovative drugs, which may pave the way for the expansion of commercial medical insurance in China [3]. - The report recommends a more cautious investment approach, focusing on undervalued stocks in the sector [3]. Company Ratings - Recommended companies include: - 三生制药 (Sangfor) with a target price of 37.58 and a potential upside of 29% [2]. - 固生堂 (Gushengtang) with a target price of 44.95 and a potential upside of 58% [2]. - 药明合联 (WuXi AppTec) with a target price of 74.00 and a potential upside of 10% [2]. - 巨子生物 (Giant Biotech) with a target price of 53.89 and a potential upside of 48% [2]. - 信达生物 (Innovent Biologics) with a target price of 110.62 and a potential upside of 29% [2]. - 中国生物制药 (China National Pharmaceutical Group) with a target price of 9.40 and a potential upside of 39% [2].

Core Viewpoint - The article highlights the advancements of Kewang Pharmaceutical's self-developed "Macrophage Connector Platform BiME" and emphasizes the need for innovative capabilities and global competitiveness in the pharmaceutical industry, particularly in the context of increasing homogeneity among products [1][2]. Company Summary - Kewang Pharmaceutical, founded 8 years ago in Pudong, focuses on key targets in oncology and autoimmune diseases, with a pipeline of immune therapies that have global competitiveness, including 4 FIC and BIC products in various clinical stages and several preclinical pipelines, with plans to list on the Hong Kong stock market this year [1]. - In 2023, Kewang Pharmaceutical entered a global collaboration with AstraZeneca worth over $1.7 billion, aimed at advancing the BiME platform, which targets the tumor microenvironment and aims to activate macrophages for treating cancers like liver and stomach cancer that lack effective therapies [2]. Industry Summary - The capital market shows strong interest in innovative pharmaceutical companies, as evidenced by Jinfang Pharmaceutical's IPO in Hong Kong, which raised $268 million, marking the largest fundraising in the Hong Kong 18A sector since 2022 [4]. - In the first half of this year, Pudong's biopharmaceutical companies engaged in nearly 30 outbound transactions, accounting for 31% of the national total and 14% of the global total [4]. - The Pudong New Area has recently announced a plan to enhance its biopharmaceutical industry, aiming to become a global hub for innovative drug and device launches, as well as a preferred location for scientists' innovation and entrepreneurship [5].

Core Viewpoint - The announcement highlights the initiation of the clinical trial for GFH276, a novel Pan RAS(ON) inhibitor developed by the company, targeting RAS mutation-driven advanced solid tumors, with significant market potential as no similar drugs are currently approved globally [1][2]. Group 1: Clinical Development - GFH276 has entered the I/II phase clinical trial, with the first patient enrolled recently, following approval from the National Medical Products Administration [1]. - The trial will be conducted at approximately 10 research centers, including Sun Yat-sen University Cancer Center and Fudan University Shanghai Cancer Center, focusing on safety, tolerability, pharmacokinetics, and preliminary efficacy [1]. - GFH276 is the third RAS-targeted therapy from the company's pipeline to enter clinical research, following the successful launch of GFH925 and the development of GFH375 [1]. Group 2: Market Potential - According to Frost & Sullivan, the global cancer incidence is expected to reach nearly 22 million by 2025, with approximately 30% (over 6.5 million) of patients having tumors with various RAS gene mutations [1]. - GFH276 is positioned among the top three global candidates in the Pan RAS(ON) inhibitor space, indicating a strong competitive advantage [1]. Group 3: Mechanism of Action - GFH276 is a unique oral molecular glue that employs a three-complex mechanism (CypA-GFH276-RAS) to effectively inhibit both wild-type and mutant RAS proteins, including common KRAS mutations [3]. - Preclinical studies demonstrate dose-dependent anti-tumor activity of GFH276, promoting tumor regression in various KRAS-mutant tumor models, and it is expected to overcome limitations of existing therapies related to adaptive and acquired resistance [3]. Group 4: Company Insights - The Chief Medical Officer of the company emphasized the accumulated experience in RAS-targeted therapy development through the successful launches of GFH925 and GFH375, highlighting the innovative product matrix in RAS therapies [2].

Core Viewpoint - The successful IPO of Jinfang Pharmaceutical on the Hong Kong Stock Exchange marks a significant milestone in the innovative drug sector, with a first-day increase of nearly 110% and a market capitalization approaching 15 billion [1][2]. Group 1: Company Overview - Jinfang Pharmaceutical, founded in 2017 by returning scientist Lü Qiang, focuses on the research and development of oncology and autoimmune drugs [1][2]. - The company has completed seven rounds of financing totaling 1.421 billion, with a post-investment valuation of 3.124 billion after the C+ round [1]. - The company has a strong foundation of cornerstone investors, including RTW Fund and OrbiMed, with over half being professional pharmaceutical investment institutions [1][2]. Group 2: Product Pipeline and Market Position - Jinfang's core product, Fluzelezib, is set to be launched in August 2024, making it the first KRAS G12C inhibitor approved in China and the third globally [2][3]. - The KRAS target is still in its early stages, with the overall market not yet fully developed, but Jinfang is positioned to be among the first to market with its product [2][3]. - The company has established multiple business development (BD) collaborations, contributing significantly to its revenue stream [7][8]. Group 3: Financial Performance and Revenue Sources - Jinfang's revenue for 2023, 2024, and the first four months of 2025 were reported at 73.73 million, 105 million, and 82.15 million respectively, with corresponding losses of 508 million, 678 million, and 6.6 million [8]. - The company has relied on BD transactions for income, which has become a core revenue source, although this dependence poses potential risks [8][9]. - The termination of the overseas rights for Fluzelezib with Innovent Biologics raised concerns about the future market prospects of this core product [9].

Core Viewpoint - GenFleet Therapeutics successfully listed on the Hong Kong Stock Exchange on September 19, 2025, marking a significant milestone in its development and showcasing its innovative strength and growth potential [1][3]. Company Overview - GenFleet Therapeutics is the first new drug company in the 18A sector to have a listed product and authorized revenue during its IPO phase. Its product, Fluorazepine, is the first KRAS G12C inhibitor approved in China and the third globally [3][7]. - The company has completed multiple licensing transactions with domestic and international listed companies, including Innovent Biologics and Verastem Oncology, since 2021, generating authorized revenue [3][4]. Product Pipeline - GenFleet's product pipeline includes several original products that are leading in development speed both domestically and internationally. Fluorazepine received priority review qualification for domestic listing after six years of development [4]. - The company is advancing GFH375, an oral KRAS G12D inhibitor, which is in the first tier of development for treating pancreatic cancer and non-small cell lung cancer (NSCLC) [4]. - The pipeline also features GFH276, a pan-RAS inhibitor, which has entered Phase I/II clinical trials in China, positioning it among the leading candidates in the domestic market [4]. Innovative Therapies - GenFleet has introduced multiple globally innovative dual-target therapies, addressing significant clinical needs in markets such as pancreatic cancer and NSCLC. The KROCUS study presents the first global KRAS+EGFR first-line treatment for NSCLC [5]. - GFS202A is the first clinical-stage dual antibody therapy targeting GDF15/IL-6 for cachexia, with potential applications in chronic diseases like heart failure and chronic kidney disease [5]. - The FAScon platform represents a novel antibody-drug conjugate (ADC) approach, combining functional antibodies with targeted drug delivery, aiming to revolutionize traditional ADC development [5]. Collaboration and Support - PharmaBlock Technology plays a crucial role in supporting GenFleet's core pipeline through its comprehensive small molecule drug development services, including rapid synthesis of preclinical compounds and customized synthesis for clinical production [6]. - The collaboration emphasizes sustainable development through low-carbon production technologies and green chemistry practices, enhancing production efficiency while minimizing environmental impact [6]. Recognition and Achievements - GenFleet has received several accolades, including the national-level "Little Giant" designation and recognition as a high-tech enterprise, reflecting its innovative capabilities and growth trajectory [8]. - The company has established a robust commercial cooperation network, engaging in strategic licensing agreements and global clinical collaborations with various domestic and international firms [8].