Core Viewpoint - The Shanghai Stock Exchange emphasizes its mission to support the real economy and enhance its capacity to support technological innovation through the STAR Market, which has established inclusive listing standards for unprofitable companies [1][5]. Group 1: Listing Standards - The STAR Market has developed five sets of listing standards, with the second to fifth sets not imposing profit thresholds, thereby creating diverse pathways for unprofitable companies to access the capital market [1][2]. - The second to fourth sets of standards assess companies based on "revenue scale + R&D intensity," "revenue scale + cash flow," and "revenue scale + market capitalization," respectively, catering to hard technology enterprises with strong R&D capabilities [1][2]. - The fifth set of standards evaluates companies based on "market capitalization + stage of R&D achievements," allowing innovative firms with promising technologies but no commercialization to list [2]. Group 2: Performance of Unprofitable Companies - As of 2024, 54 unprofitable companies listed on the STAR Market achieved a total revenue of 1,745 billion, a 24% year-on-year increase, with 26 companies exceeding 100 million in revenue [3]. - These companies collectively reduced their net losses by 36% to 136 billion, with 22 companies achieving profitability and "delisting" from the unprofitable category [3]. - In the first half of 2025, these companies reported a total revenue of 999 billion, an 8% increase, and reduced net losses by 70% to 15 billion [3]. Group 3: Industry Highlights - Leading companies in the innovative drug sector, such as BeiGene and Baillie Gifford, have achieved significant sales milestones, with BeiGene's new drug generating over 10 billion in sales in just six months [4]. - In the semiconductor sector, companies like SMIC and Cambrian are breaking foreign monopolies and enhancing domestic capabilities in AI chip development [4]. - The STAR Market has facilitated the approval of 46 drugs/vaccines, with 20 new innovative drugs launched domestically, showcasing the rapid advancement of unprofitable companies towards commercialization [6]. Group 4: Policy Impact - The STAR Market's "1+6" policy framework aims to further support unprofitable companies by creating a "STAR Growth Layer" that focuses on emerging sectors like AI and commercial aerospace [6]. - Since the implementation of this policy, 15 new IPO applications have been accepted, including four from unprofitable companies, indicating a positive market response [6]. - Companies in the STAR Growth Layer reported a 38% year-on-year revenue growth and a significant reduction in net losses by 71 billion in the first half of 2025 [6]. Group 5: Future Outlook - The STAR Market is positioned to assist unprofitable hard technology companies in transitioning from research to market, reinforcing the importance of capital support for technological self-reliance [7].

Investment Rating - The industry rating is "Positive" for the next 12 months, expecting a growth rate exceeding 10% relative to the CSI 300 index [67][79]. Core Insights - The report highlights the impressive research outcomes of Chinese pharmaceutical companies showcased at the 2025 World Lung Cancer Conference (WCLC), emphasizing the strength of innovation in the sector. It also notes that Heng Rui has further advanced its overseas licensing strategy through the NewCo model [9][67]. - The report suggests continuous monitoring of the R&D progress of Chinese pharmaceutical companies, particularly in innovative drugs and related industrial chains, benefiting from optimized procurement rules in the pharmaceutical and medical device sectors, as well as the recovery of traditional Chinese medicine and medical services due to domestic demand [9][67]. Industry News - Bai Li Tian Heng's dual-target ADC for EGFR/HER3 has shown promising results at WCLC, with a 100% overall response rate in a study involving 154 patients [18]. - BeiGene presented the latest findings from its RATIONALE studies at WCLC, demonstrating significant survival benefits for its drug in treating non-small cell lung cancer [19]. - Kangfang Biotech updated data from its HARMONi study, showing improved overall survival rates, particularly in North America [20]. Company Announcements - Heng Rui Pharma signed a licensing agreement with Braveheart Bio for the HRS-1893 project, with an upfront payment of $65 million and potential milestone payments totaling up to $1.013 billion [35]. - The new drug application for KN026 by CSPC has been accepted by the National Medical Products Administration (NMPA) [39]. - Junshi Biosciences reported positive results from its Phase III clinical trial for an anti-IL-17A monoclonal antibody [40]. Market Review - The Shanghai Composite Index rose by 2.91%, while the Shenzhen Component Index increased by 7.11%. The pharmaceutical and biological sector saw a 1.76% increase, with most sub-sectors showing positive performance [53][57]. - As of September 11, 2025, the TTM P/E ratio for the pharmaceutical and biological industry was 31.56, with a valuation premium of 148% relative to the CSI 300 [57]. Weekly Strategy - The report recommends focusing on investment opportunities in innovative drugs and medical devices, as well as sectors benefiting from domestic demand recovery, while maintaining a "Positive" industry rating [67].

Core Insights - The commercialization success of Shuwotini represents a model in China's innovative drug sector, but it has also placed Dizhi Pharmaceutical in a precarious position where its fortunes are heavily tied to this single product [1] - The company reported a 74.4% year-on-year revenue increase to 355 million yuan in the first half of 2025, but the reliance on Shuwotini raises concerns about product structure imbalance [1][4] - The rapid growth of Shuwotini's sales, which is the first targeted drug approved for EGFR Exon20ins non-small cell lung cancer, has been a significant driver of revenue, with projected sales nearing 400 million yuan in 2024 [2][4] Revenue and Financial Performance - In 2022, the company had no commercialized products, resulting in a net loss of 736 million yuan; however, after Shuwotini's approval in August 2023, revenue surged to 91.29 million yuan in 2023, although net losses widened to 1.108 billion yuan [4] - By 2024, revenue is expected to increase by 294.35% to 360 million yuan, with net losses narrowing to 846 million yuan [4] - The company’s revenue in the first half of 2025 is already close to the total for 2024, indicating strong sales momentum [4] Market Dynamics and Challenges - The inclusion of Shuwotini in the national medical insurance directory in November 2024 significantly improved drug accessibility, leading to monthly sales exceeding 25 million yuan [5] - The domestic market for EGFR Exon20ins non-small cell lung cancer has an estimated annual new patient population of about 35,000, with a peak sales potential of 2 billion yuan, indicating a clear growth ceiling [5] - The company faces challenges in international markets, as it has yet to establish a clear commercialization path for Shuwotini in the U.S., despite its approval by the FDA [6] R&D and Pipeline Concerns - The company has invested heavily in R&D, with cumulative expenditures reaching 2.204 billion yuan over three years, but concerns about the efficiency and pace of development persist [8] - The reliance on a single product like Shuwotini poses risks, especially given the natural resistance cycles associated with its target indications [7] - The company is working on expanding its pipeline, with several clinical trials ongoing, but the lack of a diversified product portfolio raises questions about long-term sustainability [7][9] Management and Market Sentiment - Multiple executives, including the chairman, have sold shares in 2025, raising market concerns about the company's future prospects [9] - The company asserts that these share sales were for personal financial needs and emphasizes its commitment to long-term value creation [9] - The shift in the pharmaceutical industry from capital-driven to value-driven models highlights the challenges faced by companies like Dizhi Pharmaceutical that depend heavily on a single product [9]

Group 1 - The core viewpoint of the news highlights the recent performance and financial metrics of Dize Pharmaceutical, including stock price movements and trading volumes [1][2] - As of September 12, Dize Pharmaceutical's stock price increased by 2.01% to 74.98 CNY per share, with a total market capitalization of 34.447 billion CNY [1] - The company has seen an 80.81% increase in stock price year-to-date, but has experienced a decline of 5.30% over the last five trading days and 12.01% over the last twenty days [1] Group 2 - Dize Pharmaceutical, established on October 27, 2017, focuses on the research and commercialization of innovative drugs, with 100% of its revenue derived from drug sales [2] - The company operates within the pharmaceutical and biotechnology sector, specifically in chemical pharmaceuticals and formulations [2] - For the first half of 2025, Dize Pharmaceutical reported a revenue of 355 million CNY, reflecting a year-on-year growth of 74.40%, while the net profit attributable to shareholders was -377 million CNY, a decrease of 9.46% [2] Group 3 - As of June 30, 2025, the top ten circulating shareholders of Dize Pharmaceutical include several new entrants, with notable holdings from Yongying Pharmaceutical Innovation Mixed Fund and others [3] - The number of shareholders decreased by 3.45% to 8,386, while the average circulating shares per person increased by 3.58% to 22,265 shares [2][3]

Core Viewpoint - The commercialization success of Shuwotini has propelled DiZhe Pharmaceutical into a challenging position, heavily reliant on this single product for revenue growth, while facing concerns over product line imbalance and future sustainability [2][3][4]. Financial Performance - In the first half of 2025, DiZhe Pharmaceutical reported a revenue increase of 74.4% year-on-year, reaching 355 million yuan, primarily driven by Shuwotini and Golixitinib [2][6]. - The company’s revenue trajectory shows a significant dependency on Shuwotini, with 2024 revenue surging 294.35% to 360 million yuan, despite a net loss of 846 million yuan [6][7]. - The company’s net loss expanded to 1.11 billion yuan in 2023, despite revenue growth following Shuwotini's approval [6][12]. Product Dependency and Market Dynamics - Shuwotini is the only approved targeted therapy for EGFR exon20ins non-small cell lung cancer, with a projected sales figure of nearly 400 million yuan in 2024 [4][8]. - The limited patient population for EGFR exon20ins mutations poses a growth ceiling, with peak sales expected to reach 2 billion yuan [9]. - The inclusion of Shuwotini in the national medical insurance directory in November 2024 significantly enhanced its market accessibility [7][9]. R&D and Pipeline Challenges - DiZhe Pharmaceutical has faced criticism regarding its R&D efficiency, with cumulative R&D expenditures reaching 2.204 billion yuan over three years, yet progress on new products has been slower than expected [12][13]. - The company is investing heavily in its production base to support Shuwotini's global supply, which raises concerns about the risks associated with reliance on a single product [11][12]. - The company has initiated global clinical trials for Shuwotini, but the effectiveness of these efforts in overcoming market limitations remains uncertain [11][12]. Executive Actions and Market Sentiment - Concerns about the company's future have been exacerbated by significant share sell-offs by executives, including the chairman, which the company attributes to personal financial needs [3][13]. - The market sentiment reflects skepticism about the sustainability of DiZhe Pharmaceutical's growth model, heavily reliant on Shuwotini, amidst a shift in the industry towards value-driven strategies [13].

Core Insights - The company reported its latest research findings on two innovative lung cancer drugs, Shuwozhe® and GaoRuizhe®, at the 2025 World Lung Cancer Conference (WCLC) [1][2] - Shuwozhe® has been approved in the U.S. as the only oral targeted therapy for EGFR Exon20ins NSCLC, demonstrating significant and durable anti-tumor efficacy with manageable safety [1] - GaoRuizhe® is undergoing ongoing research in combination with anti-PD-1 monoclonal antibodies for advanced NSCLC, showing no dose-limiting toxicities in the dose escalation phase [2] Group 1 - The company presented 11 new studies on Shuwozhe® and GaoRuizhe® in the NSCLC field at WCLC [1][2] - The international multicenter registration clinical study "Wu-Kong1B" for Shuwozhe® showed a favorable benefit/risk ratio for treating EGFR Exon20ins NSCLC [1] - Shuwozhe® received priority review approval in the U.S. in July 2025 based on the "Wu-Kong1B" study [1] Group 2 - GaoRuizhe® is currently in a study that combines it with anti-PD-1 therapy for late-stage NSCLC, with ongoing patient enrollment and data collection [2] - The research on GaoRuizhe® has not observed dose-limiting toxicities during the initial phases [2]

证券代码：688192 证券简称：迪哲医药 公告编号：2025-53 迪哲（江苏）医药股份有限公司 自愿披露关于公司肺癌领域多项最新研究成果在 2025 年世界肺癌大会（WCLC）上公布的公告 本公司董事会及全体董事保证公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 迪哲（江苏）医药股份有限公司（以下简称"公司"）于 2025 年 9 月 6 日 至 9 日在 2025 年世界肺癌大会（WCLC）上，报告了其自主研发的新型肺癌靶 向药舒沃哲®（通用名：舒沃替尼片）和高选择性 JAK1 抑制剂高瑞哲®（通用名： 戈利昔替尼胶囊）在非小细胞肺癌（NSCLC）领域的 11 项最新研究。其中，舒 沃哲®国际多中心注册临床研究"悟空 1B"（WU-KONG1B）的最新研究结果在 大会进行口头报告。 一、关于舒沃哲®相关研究 舒沃哲®首个国际多中心注册临床研究"悟空 1B"（WU-KONG1B）最新研 究结果显示，舒沃哲®二/后线治疗表皮生长因子受体（EGFR）20 号外显子插入 突变（Exon20ins）NSCLC 具有良好的获益/风险比：抗肿瘤疗效显著且持久 ...

Core Insights - The company reported on its new targeted lung cancer drug, Shuwozhe (generic name: Shuwotini tablets), and the highly selective JAK1 inhibitor, Gaoruizhe (generic name: Goliqixitini capsules), at the 2025 World Lung Cancer Conference (WCLC) [1][2] - The latest results from the international multicenter registration clinical study "WUKONG1B" for Shuwozhe showed a favorable benefit/risk ratio for treating EGFR Exon20ins NSCLC, with significant and durable anti-tumor efficacy and manageable safety [1] - Shuwozhe received priority review approval in the U.S. in July 2025, making it the only approved oral small molecule targeted therapy for EGFR Exon20ins NSCLC globally [1] Group 1 - The company presented 11 new studies related to non-small cell lung cancer (NSCLC) at WCLC [1] - The "WUKONG1B" study results were reported orally at the conference [1] - The ongoing research for Gaoruizhe in NSCLC treatment shows no dose-limiting toxicities (DLT) observed during the dose escalation phase [2] Group 2 - The research for Gaoruizhe is still ongoing with patient enrollment and data collection, which will provide important evidence for its clinical application in NSCLC [2]

Core Insights - The company reported its latest research findings on two new targeted therapies for lung cancer at the 2025 World Lung Cancer Conference (WCLC) [1] Group 1: Company Developments - The company presented 11 recent studies on its self-developed lung cancer targeted drug, Shuwotai (generic name: Shuwotai tablets), and the highly selective JAK1 inhibitor, Gaoruizhe (generic name: Golixitinib capsules) in the non-small cell lung cancer (NSCLC) field [1] - The international multicenter registration clinical study "Wukong 1B" (WU-KONG1B) of Shuwotai had its latest research results reported orally at the conference [1]

Core Viewpoint - DIZHE Pharmaceutical (688192.SH) reported promising results for its self-developed lung cancer targeted drug, Shuwozhe®, and high-selectivity JAK1 inhibitor, Gaoruizhe®, at the 2025 World Lung Cancer Conference (WCLC) [1] Group 1: Clinical Research Findings - The latest results from the international multicenter registration clinical study "WUKONG1B" for Shuwozhe® were presented at the conference [1] - Shuwozhe® demonstrated a favorable benefit/risk ratio in the treatment of non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations [1] - The overall response rate (ORR) for Shuwozhe® combined with Anlotinib in first-line treatment of EGFR-sensitive mutations with co-mutations in NSCLC was reported at 77.8%, with a disease control rate (DCR) of 100% [1]