Core Viewpoint - The implementation of the "K8 Measures" has led to a renewed focus on the fifth listing standard for unprofitable biotech companies on the STAR Market, aiming to enhance the financing environment for innovative drug firms and shift A-share valuation logic towards "technological value" and "commercial prospects" [1][5][15] Group 1: K8 Measures and STAR Market - The "K8 Measures" were introduced by the China Securities Regulatory Commission (CSRC) to support high-quality, unprofitable tech companies with key technologies and market potential to list on the STAR Market [1] - Since the introduction of the K8 Measures, two unprofitable hard tech companies have been accepted for listing, but the specific "Standard Five" for unprofitable innovative drug companies has yet to be activated [1][3] - The CSRC has reiterated its commitment to promoting the new cases under the fifth listing standard, which is expected to accelerate the financing pace for biotech companies [1][3] Group 2: Impact on Biotech Companies - Biotech companies, particularly innovative drug firms, face longer investment periods and greater uncertainty due to strict approval processes, making them highly dependent on capital [1][5] - The fifth listing standard has previously allowed 20 unprofitable biotech companies to list, with 19 of them successfully bringing 45 self-developed drugs/vaccines to market [3][5] - The introduction of the fifth standard has significantly shortened the capital cycle for these companies and has contributed to the prosperity of the biopharmaceutical primary market [3][5] Group 3: Commercialization and Financial Performance - As of 2024, the 20 companies that listed under the fifth standard collectively achieved revenues of 14.21 billion yuan, a year-on-year increase of 44.17%, with four companies expected to surpass 1 billion yuan in revenue in the coming years [12] - Companies like Ailis and Shenzhou Cell have reported significant revenue growth and profitability, attributing their success to continuous R&D investment and effective commercialization strategies [12][13] - The revised "STAR Market Attribute Evaluation Guidelines" for 2024 emphasize the importance of commercialization capabilities and revenue growth for companies seeking to list [11] Group 4: Future Prospects and Challenges - The market is keenly observing which companies will benefit first from the reactivation of the fifth listing standard, with five companies currently under review [14] - Companies with strong technological innovation capabilities and significant market potential are expected to be the first beneficiaries of the new standard [14][15] - The fifth listing standard presents both opportunities and challenges for unprofitable companies, requiring them to demonstrate their technological strengths and market potential despite not being profitable [15]

Group 1: Market Performance - A number of leading stocks reached historical highs, including well-known industry leaders such as BYD, CITIC Bank, and Xinlitai, as well as niche market leaders like Hengxin Life, which saw a 20% limit-up increase [1] - BYD's stock rose by 4.22%, driving strength in the automotive supply chain, with seven out of the top ten stocks by trading volume belonging to the automotive sector [1] - The Shanghai Composite Index increased by 0.08%, the Shenzhen Component Index rose by 0.5%, and the ChiNext Index gained 0.48% [1] Group 2: Pharmaceutical Sector - The pharmaceutical sector showed strong performance, with significant gains in chemical pharmaceuticals, CRO, medical services, and innovative drugs [5] - Heng Rui Pharmaceutical's listing on the Hong Kong stock market saw a 30.87% increase, boosting sentiment in the pharmaceutical sector [8] - Multiple significant drugs received approval for market entry, including the innovative drug Anglazavir from Guangdong Zhongsheng Pharmaceutical, which led to a limit-up for the company [9]

市场表现： 2025 年5 月22 日，医药板块涨跌幅-0.73%，跑输沪深300 指数0.67pct，涨跌幅居申万31 个子行业第14 名。各医药子行业中，医疗研发外包(+0.04%)、血液制品(-0.37%)、其他生物制品（-0.51%）表现居 前，医院（-1.83%)、线下药店(-1.65%)、医药流通（-1.37%)表现居后。个股方面，日涨幅榜前3 位分别 为三生国健(+20.00%)、亚虹医药(+12.26%)、迈威生物(+11.71%)；跌幅榜前3 位为赛升药业 （-11.63%）、拓新药业(-10.93%)、拱东医疗（-9.99%)。 行业要闻： 近日，Ionis 宣布，公司开发的反义寡核苷酸（ASO）疗法Tryngolza（Olezarsen）在Essence 临床3 期研 究中取得积极的顶线结果。数据显示，该药在治疗6 个月后显著降低了患者的甘油三酯水平，达到主要 终点，且在所有关键次要终点上也取得统计学显著改善。Olezarsen 是一种反义寡核苷酸疗法，旨在抑 制机体产生载脂蛋白C-III（apoC-III，一种在肝脏中产生的调节血液中TG 代谢的蛋白）。 风险提示：新药研发及上市不及预 ...

Core Viewpoint - The article discusses the approval of the KRAS G12C inhibitor, Goratirsen (brand name "Airikai"), by the National Medical Products Administration for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation who have received at least one systemic therapy [2][3]. Group 1: Product Approval and Financial Implications - The approval of Goratirsen triggers a milestone payment of 50 million yuan to the developer, Gako Pharmaceutical, from its partner, Ailis [3]. - Lung cancer is the most prevalent and deadly malignancy globally, with non-small cell lung cancer accounting for approximately 85% of all lung cancer cases [3]. Group 2: Clinical Study Results - The approval is based on a pivotal Phase II single-arm study assessing the safety, tolerability, and efficacy of Goratirsen in patients with advanced NSCLC who have failed or are intolerant to standard treatments [3][4]. - The study included 119 NSCLC patients, with an independent review showing a confirmed objective response rate (cORR) of 49.6% (range: 40.2%-59.0%) and a disease control rate (DCR) of 86.3% (range: 78.7%-92.0%) [4]. - The median duration of response (DOR) was 14.5 months (range: 9.6-NE), median progression-free survival (PFS) was 8.2 months (range: 5.2-11.1), and median overall survival (OS) was 17.5 months (range: 13.6-NE) [4]. Group 3: Product Features and Future Developments - Goratirsen is the only KRAS G12C inhibitor approved in China that allows for once-daily oral administration, enhancing patient convenience [4]. - Ailis plans to commercialize Goratirsen and is conducting clinical studies for its use in combination with SHP2 inhibitors for first-line treatment of NSCLC, as well as for monotherapy in multiple tumor types [4].

Group 1 - Company Zhongnan Media signed a government procurement contract worth 1.009 billion yuan for the supply of free textbooks and related teaching resources in Hunan Province for 2025, ensuring stable revenue for the company [1] - Company Zhongnan Media was established in December 2008, focusing on the publishing, distribution, and printing of publications [2] Group 2 - Company Tongling Nonferrous Metals announced the resignation of its general manager and deputy general manager due to higher-level assignments [3] - Company Tongling Nonferrous Metals was founded in November 1996, primarily engaged in the mining and processing of copper, iron, and sulfur gold [4] Group 3 - Company Xinyi Co. plans to reduce its shareholding by no more than 1% due to personal asset allocation needs [5] - Company Xinyi Co. was established in April 1996, specializing in the research, production, and sales of functional new materials based on organic synthetic resins [6] Group 4 - Company Xinhua Pharmaceutical received approval for the registration of ibuprofen suspension drops, a non-prescription drug for relieving fever and mild to moderate pain in children [7] - Company Xinhua Pharmaceutical was founded in November 1998, focusing on the sales of raw materials and intermediates, as well as chemical products [8] Group 5 - Company Emei Mountain A elected Tong Jianming as a director and appointed him as the general manager [9] - Company Emei Mountain A was established in October 1997, primarily engaged in tourism services, including ticket sales and hotel operations [10] Group 6 - Company Heng Rui Medicine announced the approval of its innovative drug, Regaglitin Metformin tablets, for market launch, aimed at improving blood sugar control in type 2 diabetes patients [11] - Company Heng Rui Medicine was founded in April 1997, focusing on the research, production, and sales of pharmaceuticals [12] Group 7 - Company Chongqing Rural Commercial Bank announced the approval of Tang Li's qualification as vice president [13] - Company Chongqing Rural Commercial Bank was established in June 2008, focusing on inclusive finance and corporate financial services [14] Group 8 - Company Weili Medical received certification from the Canadian Ministry of Health for its extraction bag, allowing legal sales in the Canadian market [15] - Company Weili Medical was founded in April 2004, specializing in the research, production, and sales of medical devices in various fields [16] Group 9 - Company Ailis received approval for its KRAS G12C inhibitor, a new drug for treating advanced non-small cell lung cancer [17] - Company Ailis was established in March 2004, focusing on innovative drug research and development in oncology [18] Group 10 - Company Renfu Pharmaceutical received registration certificates for two new drugs, including methylprednisolone tablets and hydrocodone ibuprofen tablets [19] - Company Renfu Pharmaceutical was founded in March 1993, focusing on the research, production, and sales of pharmaceuticals [20] Group 11 - Company Siwei Tuxin received multiple invention patent certificates from the National Intellectual Property Administration [21] - Company Siwei Tuxin was established in December 2002, focusing on navigation maps, intelligent driving, and automotive electronic chips [22] Group 12 - Company Changhong High-Tech received a warning letter from the Ningbo Securities Regulatory Bureau for failing to disclose related party transactions [23] - Company Changhong High-Tech was founded in June 2012, focusing on the research, production, and sales of styrene thermoplastic elastomers [24] Group 13 - Company Gansu Energy Chemical announced the resignation of its director and general counsel due to organizational adjustments [25] - Company Gansu Energy Chemical was established in December 1996, focusing on coal mining and sales [26] Group 14 - Company Shanghai Construction received land use rights for a residential project in Tianjin, with a total investment of approximately 330 million yuan [27] - Company Shanghai Construction was founded in June 1998, focusing on construction, design consulting, and real estate development [28] Group 15 - Company Chengdu Xian Dao announced that a major shareholder plans to increase its stake in the company by 25 to 50 million yuan [29] - Company Chengdu Xian Dao was established in February 2012, focusing on drug research and development services [30] Group 16 - Company Hunan Silver announced the resignation of its deputy general manager due to organizational adjustments [31] - Company Hunan Silver was founded in November 2004, focusing on the smelting and sales of silver and other precious metals [32] Group 17 - Company China Chemical reported a total contract amount of 123.017 billion yuan for the first four months of the year [33] - Company China Chemical was established in September 2008, focusing on construction engineering and modern services [34] Group 18 - Company Borui Pharmaceutical received a registration certificate for iodinated contrast agent injection [35] - Company Borui Pharmaceutical was founded in October 2001, focusing on the research and production of pharmaceutical intermediates and raw materials [36] Group 19 - Company Wanhua Chemical announced a technical transformation of its ethylene unit, aiming to diversify raw materials and enhance competitiveness [37] - Company Wanhua Chemical was established in December 1998, focusing on the research, production, and sales of polyurethane and fine chemicals [38] Group 20 - Company ST Houlv received approval for its injectable cephalosporin sodium to pass the consistency evaluation for generic drugs [39] - Company ST Houlv was founded in June 2005, focusing on drug research, production, and sales [40] Group 21 - Company Anka Intelligent announced a targeted reduction of capital for its subsidiary [41] - Company Anka Intelligent was established in May 2004, focusing on the research and development of power system solutions [42] Group 22 - Company Huaming Intelligent announced financial support for its subsidiary [43] - Company Huaming Intelligent was founded in August 2001, focusing on intelligent systems and services [44] Group 23 - Company Foton Motor received a central subsidy of 124 million yuan for promoting new energy vehicles [45] - Company Foton Motor was established in August 1996, focusing on vehicles and mobile equipment [46] Group 24 - Company Guangsheng Tang received a registration certificate for ritonavir tablets, used in HIV treatment [47] - Company Guangsheng Tang was founded in June 2001, focusing on the research and production of antiviral drugs [48] Group 25 - Company Kexing Pharmaceutical received FDA approval for clinical trials of its GB18 injection in the United States [49] - Company Kexing Pharmaceutical was established in August 1997, focusing on the research and production of recombinant protein drugs [50] Group 26 - Company Heng Rui Medicine announced the final price for its H-share public offering at 44.05 HKD per share [51] - Company Heng Rui Medicine was founded in April 1997, focusing on the research, production, and sales of pharmaceuticals [52] Group 27 - Company Wandong Medical elected a new chairman following the resignation of the previous chairman [53] - Company Wandong Medical was established in May 1997, focusing on the research, production, and sales of medical imaging equipment [54] Group 28 - Company Qixia Construction announced a plan to reduce its shareholding by no more than 3% [55] - Company Qixia Construction was founded in December 1999, focusing on real estate development and management [56] Group 29 - Company Dasheng Intelligent signed a contract worth 11.5 million yuan for a high-efficiency machine room project [57] - Company Dasheng Intelligent was established in March 1995, focusing on AIoT intelligent management platforms [58] Group 30 - Company Huashi Technology announced an extension of the detention period for its actual controller [59] - Company Huashi Technology was founded in June 1998, focusing on information system integration and technical services [60] Group 31 - Company Tianzhihang announced plans to increase capital for its subsidiary [61] - Company Tianzhihang was established in October 2010, focusing on orthopedic surgical navigation robots [62] Group 32 - Company Pingzhi Information signed a procurement framework agreement with China Mobile for base station antennas [63] - Company Pingzhi Information was founded in November 2002, focusing on communication equipment and services [64] Group 33 - Company Mengke Pharmaceutical received acceptance for its new drug application for a new antibacterial drug [65] - Company Mengke Pharmaceutical was established in August 2012, focusing on small molecule drug research [66] Group 34 - Company Kede Education announced a change in its actual controller to a state-owned asset supervision committee [67] - Company Kede Education was founded in January 2003, focusing on education services [68] Group 35 - Company Jinlong Automobile elected a new chairman following the board meeting [69] - Company Jinlong Automobile was established in October 1996, focusing on the production and sales of buses [70] Group 36 - Company Jushen Co. received dividends totaling 95.7 million yuan from its subsidiaries [71] - Company Jushen Co. was founded in November 2011, focusing on logistics and warehousing services [72] Group 37 - Company Qingyun Technology announced plans for shareholders to reduce their holdings by up to 4.5% [73] - Company Qingyun Technology was established in April 2012, focusing on cloud computing products and services [74] Group 38 - Company Shengdexintai received a procurement notice from Dongfang Electric for a project worth 234 million yuan [75] - Company Shengdexintai was founded in October 2001, focusing on the production and sales of energy equipment [76] Group 39 - Company Juzhi Technology announced a plan for a director to reduce his holdings by up to 400,000 shares [77] - Company Juzhi Technology was established in November 2007, focusing on machine vision equipment [78] Group 40 - Company Sanrenxing announced plans for shareholders to reduce their holdings by up to 3% [79] - Company Sanrenxing was founded in August 2003, focusing on integrated marketing services [80] Group 41 - Company Transsion Holdings announced plans to increase capital for its subsidiary by 70 million yuan [81] - Company Transsion Holdings was established in August 2013, focusing on smart terminal design and sales [82] Group 42 - Company Jinling Pharmaceutical received approval for its raw material drug for iron deficiency anemia [83] - Company Jinling Pharmaceutical was founded in September 1998, focusing on drug manufacturing and healthcare services [84] Group 43 - Company Xiyu Tourism announced plans for shareholders to reduce their holdings by up to 3% [85] - Company Xiyu Tourism was established in January 2001, focusing on tourism and scenic area management [86]

Group 1 - The company's KRAS G12C inhibitor, citric acid gorasetinib (brand name "Airikai"), has received approval from the National Medical Products Administration for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutations who have received at least one systemic therapy [1] - As of September 28, 2024, a total of 119 NSCLC patients were included in the analysis [1] - The confirmed objective response rate (cORR) assessed by the Independent Radiologic Review Committee (IRC) reached 49.6% (40.2%-59.0%) [1] - The disease control rate (DCR) was 86.3% (78.7%-92.0%) [1] - The median duration of response (DOR) was 14.5 months (9.6-NE) [1] - The median progression-free survival (PFS) was 8.2 months (5.2-11.1) [1] - The median overall survival (OS) was 17.5 months (13.6-NE) [1]

Core Viewpoint - The National Medical Products Administration has conditionally approved the innovative drug Glecirasib (brand name: Airikai) developed by Elysium, which is indicated for adult patients with advanced non-small cell lung cancer (NSCLC) harboring KRAS G12C mutations who have received at least one prior systemic therapy [1] Group 1 - The drug Glecirasib is classified as a first-class innovative drug [1] - The approval was granted through a priority review and approval process [1] - The target patient population includes adults with advanced NSCLC and specific genetic mutations [1]