Core Viewpoint - The company, Dige Medical, will present its newly developed targeted lung cancer drugs, ZEGFROVY (generic name: Shuwotini tablets) and a highly selective JAK1 inhibitor, Goliqitini capsules, at the 2025 World Lung Cancer Conference (WCLC) in Barcelona, Spain, from September 6 to 9, 2025 [1] Summary by Relevant Categories - **Product Development** - Dige Medical is set to showcase multiple latest research results on its innovative lung cancer therapies at an upcoming international conference [1] - The international multicenter registration clinical study "Wu-Kong1B" for ZEGFROVY has had its latest data selected for an oral presentation [1]

Core Viewpoint - The report highlights a positive performance in the pharmaceutical sector, particularly in the innovative drug industry, driven by ongoing licensing agreements and supportive domestic policies [3]. Fund Performance - The fund reported a profit of 26.97 million yuan in Q2 2025, with a weighted average profit per fund share of 0.0627 yuan [2]. - The fund's net asset value (NAV) growth rate for Q2 was 7.62%, and the fund size reached 375 million yuan by the end of Q2 [2][16]. - As of July 18, the fund's unit NAV was 0.96 yuan [2]. - The fund's performance over the past three months showed a NAV growth rate of 14.74%, ranking 112 out of 138 comparable funds [4]. - Over the past six months, the fund's NAV growth rate was 25.40%, ranking 100 out of 138 [4]. - The one-year NAV growth rate was 24.99%, also ranking 100 out of 133 [4]. - The three-year NAV growth rate was 4.99%, ranking 46 out of 107 [4]. Investment Strategy - The fund manager expressed optimism about the innovative drug sector, indicating a shift from a general revaluation phase to a stage where actual performance and partnerships will be tested [3]. - The strategy includes a "barbell" approach, focusing on high-probability or high-return innovative drug companies [3]. - The fund is also looking at sectors with strong performance, such as orthopedics and upstream innovative drugs, while making early allocations in improving sectors like medical devices [3]. - New technologies like AI and brain-computer interfaces are expected to transform the healthcare system, although short-term financial impacts on related companies may be limited [3]. Risk and Return Metrics - The fund's three-year Sharpe ratio was 0.1406, ranking 41 out of 105 comparable funds [9]. - The maximum drawdown over the past three years was 29.8%, ranking 97 out of 106 [11]. - The fund's average stock position over the past three years was 85.43%, slightly below the comparable average of 86.95% [14].

Core Viewpoint - The approval of the innovative drug Shuwozhe by Dize Pharmaceutical for treating EGFR exon20ins NSCLC marks a significant advancement in addressing a challenging target that has been difficult to treat with existing therapies [1][2]. Group 1: Drug Approval and Market Position - Dize Pharmaceutical's drug Shuwozhe has received accelerated approval from the FDA for use in adult patients with locally advanced or metastatic NSCLC harboring EGFR exon20ins mutations [1][2]. - Shuwozhe is recognized as the first and only small molecule targeted therapy for EGFR exon20ins NSCLC globally, having previously received approval in China [2]. Group 2: Clinical Research and Development - The approval was based on data from the international multicenter clinical study "Wukong 1B," which demonstrated the efficacy and safety of Shuwozhe in patients with EGFR exon20ins NSCLC [3]. - The drug's submission process involved extensive communication with the FDA, ensuring alignment on data and documentation requirements, and achieving a "zero deficiency" status during the independent registration process [3]. Group 3: Strategic Vision and Internationalization - Dize Pharmaceutical aims for global market competitiveness through solid scientific research and early international multicenter clinical trials [4]. - The company emphasizes the importance of maintaining a clear strategic focus and adaptability in the face of unforeseen events during international clinical trials [4]. - Dize Pharmaceutical's strategy includes direct market entry for its drugs, contrasting with other domestic companies that often rely on external partners for commercialization [4][5].

Core Viewpoint - The company, Dize Pharmaceutical, emphasizes its commitment to "source innovation" and "global competition," successfully validating its capability in international multi-center clinical research and overseas approval for innovative drugs [1][3]. Group 1: Company Overview - Dize Pharmaceutical focuses on innovative therapies for malignant tumors and immune diseases, aiming to address unmet clinical needs globally [1][2]. - The company has established seven globally competitive product pipelines, with two leading products, Shuwozhe and Huiruozhe, having reached key clinical trial endpoints and received approvals in China and the U.S. [1][3]. Group 2: Product Development and Clinical Trials - Shuwozhe was included in the NCCN guidelines for treating EGFR exon20ins non-small cell lung cancer (NSCLC) and received FDA approval, filling a significant treatment gap [2][3]. - The company has conducted over 200 clinical trials across more than 20 countries, with ongoing global Phase III clinical studies for Shuwozhe and DZD8586 [4][5]. Group 3: Financial Performance - In 2024, Dize Pharmaceutical reported a revenue of 360 million yuan, a 294% increase year-on-year, and for Q1 2025, revenue reached 160 million yuan, reflecting a 96% growth [6]. Group 4: Strategic Insights - The company advocates for early international multi-center clinical trials to validate drugs and gain international recognition, suggesting that this approach is crucial for domestic pharmaceutical companies aiming for global markets [4][5]. - Dize Pharmaceutical's core strategy involves developing drugs for global competition while establishing technological barriers in familiar and advantageous fields [5][6].

Group 1 - The Shanghai Stock Exchange has released the "Self-Regulatory Supervision Guidelines for Companies Listed on the Sci-Tech Innovation Board No. 5 - Sci-Tech Growth Tier" [1] - The reform does not impose additional listing thresholds for unprofitable companies entering the Sci-Tech Growth Tier, allowing 32 existing unprofitable companies to enter immediately upon the guideline's implementation [1] - Newly registered unprofitable companies will enter the Sci-Tech Growth Tier from the date of their listing [1] Group 2 - Investors participating in the subscription and trading of newly registered stocks in the Sci-Tech Growth Tier must sign a "Risk Disclosure Statement for the Sci-Tech Growth Tier" [2] - The 32 existing companies that have not yet removed the "U" designation include: Zejing Pharmaceutical, Junshi Biosciences, Frontier Biotech, Qingyun Technology, Hehui Optoelectronics, Jingjin Electric, BeiGene, Dize Pharmaceutical, Maiwei Biotech, Aojie Technology, Yuhong Pharmaceutical, Shouyao Holdings, Haichuang Pharmaceutical, CloudWalk Technology, Yifang Biotech, Obsidian Optics, Mengke Pharmaceutical, Nuo Cheng Jianhua, Xinke Mobile, Xinghuan Technology, Yutai Micro, Yuntian Lifa, Tianzhihang, Qi Anxin, Hanwujin, Yihua Tong, Aifute, Huizhiwei, Xinlian Integrated, Zhixiang Jintai, Shengke Communication, and Zhongjuxin [2]

Core Viewpoint - Dize Pharmaceutical's Shuwotai (舒沃替尼片) has been included in the NCCN guidelines for non-small cell lung cancer (NSCLC), marking it as the only small molecule targeted therapy for EGFR exon 20 insertion mutations globally [1][2] Group 1: Product Development and Approval - Shuwotai has received priority review and approval from the FDA, highlighting its significance in the treatment landscape for NSCLC patients with specific mutations [1] - The drug represents a breakthrough in addressing the challenges of drug development, providing a safe and effective targeted treatment option for patients [1] Group 2: Research and Validation - The successful transition from domestic clinical research ("Wukong 6") to international multi-center studies ("Wukong 1B") signifies a comprehensive validation of a Chinese-developed innovative drug on a global scale [1] - The research led by Professor Wang Mengzhao from Peking Union Medical College Hospital emphasizes the drug's potential impact on patient care [1] Group 3: Company Vision and Investment Perspective - Dize Pharmaceutical's founder, Zhang Xiaolin, emphasizes the company's commitment to "source innovation" and "global competition," establishing a strong foundation for its drug development capabilities [2] - Investment perspectives highlight the importance of teams that combine scientific expertise with entrepreneurial spirit, suggesting a strong investment rationale for Dize Pharmaceutical [2] - The success of Shuwotai is seen as a demonstration of China's capabilities in the global pharmaceutical market, potentially paving the way for more Chinese original molecules and companies to gain international recognition [2]

Core Insights - The approval of ZEGFROVY (suwotrectin) by the FDA and its inclusion in the NCCN guidelines marks a significant milestone for the company and the industry, establishing it as the first and only targeted therapy for EGFR exon20ins NSCLC globally [1][2] - The successful development of ZEGFROVY demonstrates the potential for Chinese biotech firms to innovate and compete on a global scale, shifting from technology output to value output [2] Company Developments - ZEGFROVY is recognized as the first innovative drug developed independently in China to receive approval in the U.S., highlighting the company's capability in full lifecycle drug development [1] - The company emphasizes its commitment to "source innovation" and global competition, which has been validated through the successful launch of ZEGFROVY [1][2] Industry Implications - The success of ZEGFROVY encourages other companies to plan international clinical trials and global registration strategies from the early stages of drug development [2] - There is a call for a clear tiered evaluation system for innovative drugs at the national level, which would provide institutional incentives for source innovation and guide the industry towards high-quality development [2]

Group 1 - The core viewpoint of the news is that Dizhihua's drug, Shuwotini (舒沃替尼片), has been included in the National Comprehensive Cancer Network (NCCN) guidelines for the treatment of non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, marking it as the only small molecule targeted therapy recognized globally for this specific mutation [1] - Shuwotini is an oral, irreversible, highly selective EGFR tyrosine kinase inhibitor designed for patients with locally advanced or metastatic NSCLC who have progressed after platinum-based chemotherapy or are intolerant to it, and have confirmed EGFR exon 20 insertion mutations [1] - The successful approval of Shuwotini by the FDA was highlighted during a press conference, where a leading researcher emphasized its potential to reshape treatment paradigms in the field of lung cancer [1] Group 2 - The founder and CEO of Dizhihua, Dr. Zhang Xiaolin, articulated the company's commitment to "source innovation" and "global competition," emphasizing the successful development and approval of a globally innovative drug from inception to market [2] - Dr. Zhang outlined the "Dizhihua Path," which includes a solid scientific foundation, early collaboration with top international research centers, and a strategic focus on product investment [2] - The company aims to integrate Chinese cultural elements into its projects to facilitate global recognition of Chinese innovation, with Shuwotini's approval in the U.S. exemplifying the "Wukong Spirit" of breaking boundaries through scientific strength [2]

Core Viewpoint - The Shanghai Stock Exchange Science and Technology Innovation Board Biopharmaceutical Index has shown strong performance, with significant increases in constituent stocks, indicating a positive trend in the biopharmaceutical sector [1][3]. Market Performance - As of July 11, 2025, the Biopharmaceutical Index rose by 1.23%, with notable gains from stocks such as Yifang Biotech (+10.31%), Shouyao Holdings (+8.34%), and Te Bao Biotech (+7.18%) [1]. - The Jiashi Science and Technology Medicine ETF (588700) also increased by 1.14%, marking its third consecutive rise [1]. Liquidity and Trading Volume - The Jiashi Science and Technology Medicine ETF recorded a turnover rate of 9.54% and a trading volume of 21.11 million yuan [3]. - Over the past month, the ETF has maintained an average daily trading volume of 33.32 million yuan, ranking first among comparable funds [3]. Fund Growth and Performance - In the last two weeks, the Jiashi Science and Technology Medicine ETF's scale increased by 17.56 million yuan, leading among comparable funds [3]. - The ETF's net value has risen by 37.70% over the past year, with a maximum single-month return of 23.29% since its inception [3]. Top Holdings - As of June 30, 2025, the top ten weighted stocks in the Biopharmaceutical Index accounted for 50.3% of the index, including companies like United Imaging Healthcare, BeiGene, and Huatai Medical [3][5]. Policy Support and Market Outlook - Recent policy documents have been released to support the high-quality development of innovative drugs, highlighting government backing for the sector [6]. - The number of innovative drugs in development in China has reached over 4,000, representing approximately 30% of the global total [5][6].

Group 1 - The core viewpoint of the articles highlights the renewed activity in the innovative drug sector, driven by supportive government policies and recent approvals of innovative drugs in the domestic market [1][2] - The National Healthcare Security Administration and the National Health Commission have issued measures to support the high-quality development of innovative drugs, including 16 specific measures across five areas [1] - The introduction of a commercial health insurance directory for innovative drugs aims to include high-value, clinically significant drugs that are not yet part of the basic medical insurance list, indicating a shift towards multi-layered medical insurance systems [1] Group 2 - East China Securities emphasizes the strong policy support for innovative drug development, which is expected to lead to significant growth in the market as new drugs are approved and commercial insurance directories are established [2] - The successful international approval of domestic innovative drugs, such as the approval of Shuwotini by Dize Pharmaceutical in the U.S., showcases the international competitiveness of local innovative drugs [2] - The innovative drug sector is identified as a core investment theme within the biopharmaceutical industry, with recommendations to explore investment opportunities in related segments such as medical devices, traditional Chinese medicine, chain pharmacies, and medical services [2]