人生最大的痛苦，大多来源于能力配不上野心。 ——语出王小波。 引 言 鉴于发行速度可以被管控以及科创方向可以被引导，走到今天的股票上市注册制具有了明显核准制的"影子"。而带有核准制"影子"的注册制，则与中小投资 者占主要组成部分的我国证券市场"市情"相匹配。 在目前的制度下，证券监管者客观上通过"撤回""暂缓""否决"等手段为中小投资者"屏蔽"掉了部分高风险的IPO标的。"即便是部分具有较强科创属性但是持 续盈利能力欠佳的IPO标的，同样难以通过审议。"一位投行人士对《奕泽财经》表示。 即，在当下的IPO市场，高风险乃至明显有损中小投资者利益的IPO标的，即便其具备"硬科技"实力，依然无法通过IPO融资。 从如上IPO审议逻辑而言，9月24日的"上会"，对百奥赛图来说是一场不小的考验。 图 1 百奥赛图IPO进程（来源：上交所） 通俗地说，新药在研发阶段，需要在小鼠身上进行实验，以证明药效。通过敲除和编辑基因的方式，在小鼠身上模拟出接近于人类的免疫系统，由此而先行 验证出药物的作用机制和效果。靠着基因编辑，沈月雷获得了第一桶金。 2009年，沈月雷回国创办了百奥赛图。早期的百奥赛图还是围绕为实验室提供小鼠做模 ...

Core Viewpoint - Rare diseases are a global public health issue and should be prioritized in health investment strategies to address the challenges they pose [1][2]. Group 1: Importance of Rare Diseases - The rare disease population is among the most vulnerable and requires prioritization to avoid falling behind in healthcare [2]. - There is a global consensus that rare diseases are not only medical challenges but also involve social, economic, and human rights issues [2]. Group 2: Current Status in China - China has defined 207 rare diseases in its catalog, but this is limited compared to over 10,000 rare diseases globally, indicating a significant lag [2]. - Legislative measures are urgently needed to systematically advance the prevention and treatment of rare diseases in China [2]. Group 3: Innovation and Development - Comprehensive support for the development of the rare disease industry is essential, including promoting innovative technologies and enhancing international competitiveness [3]. - China has shown significant strength in innovative drug development for rare diseases, moving from a follower to a key player in the field [4][6]. Group 4: Future Prospects - The treatment of rare diseases is shifting from symptomatic treatment to addressing root causes, with gene therapy and editing technologies providing new possibilities [5]. - China is expected to continue narrowing the gap with Western countries and may achieve breakthroughs in more areas of rare disease treatment [6]. Group 5: Collaborative Efforts - The China Rare Disease Summit serves as a major academic event, facilitating discussions among experts from various fields to promote the development of rare disease initiatives in China [6].

Core Viewpoint - The article discusses the advancements in prime editing technology, particularly the development of the next-generation prime editor (vPE) that significantly reduces genomic errors compared to its predecessor, the original prime editor (PE) [3][4][5]. Group 1: Prime Editing Technology - Prime Editor (PE) is an advanced CRISPR gene editing tool developed by Professor Liu Ruqian's team in 2019, capable of editing and repairing 89% of 75,000 known pathogenic human genetic mutations [3][5]. - The editing process involves the prime editor binding to the genomic target, creating a single-strand DNA cut, and using pegRNA to guide the insertion or replacement of new DNA sequences [5][6]. - A significant challenge remains in eliminating errors produced as byproducts of prime editing, specifically insertion/deletion mutations (indels) that can lead to unpredictable and potentially harmful DNA sequences [5][6]. Group 2: Advances in Error Reduction - The research team identified key factors driving indel error formation, including the potential for the edited 3' new strand to extend beyond the pegRNA template and the conversion of single-strand cuts into double-strand breaks due to mismatch repair [6][7]. - By engineering the prime editor to induce instability in the competitive 5' strand, the team discovered a significant reduction in indel errors, leading to the development of the next-generation prime editor (vPE) [7][9]. - The vPE demonstrates a substantial improvement in editing efficiency while reducing the indel error rate to 1/60 of the original prime editor, with errors occurring only once every 543 edits [9].

Summary of Key Points Core Viewpoint - This week, one new stock will be available for subscription, while four companies are undergoing IPO reviews, indicating ongoing activity in the capital markets [2][3]. Group 1: New Stock Subscription - One new stock, Aomeisen, will be available for subscription on Monday, September 25 [2]. - Last week, Shichang Co. debuted on the North Exchange, experiencing a significant first-day increase of 271.56% [2]. Group 2: Company Performance and Financials - Shichang Co. specializes in the research, production, and sales of automotive fuel systems, primarily selling to major vehicle manufacturers like Geely and FAW [2]. - Baiaosaitu, known as the "first stock in gene editing," plans to raise approximately 11.85 billion yuan for early drug development services and other projects [3][5]. - Baiaosaitu's projected revenues for 2022, 2023, and 2024 are 534 million yuan, 717 million yuan, and 980 million yuan, respectively, with net profits expected to improve from a loss of 602 million yuan in 2022 to a profit of 33.54 million yuan in 2024 [3][4]. Group 3: Fundraising and Investment Plans - The fundraising plan for Baiaosaitu includes allocations of 45.36 million yuan for early drug development services, 31.65 million yuan for antibody drug research, and 16.5 million yuan for preclinical research [6]. - The total investment amount for these projects is 118.5 million yuan, with the majority directed towards early drug development services [6].

Core Viewpoint - Morgan Stanley has initiated a "Buy" rating for CRISPR Therapeutics (CRSP.US), highlighting the company's unique advantages in the gene editing field due to its pipeline potential [1] Company Summary - CRISPR Therapeutics is collaborating with Vertex Pharmaceuticals (VRTX.US) to sell the Casgevy in vivo gene editing therapy, providing a faster market entry path through its own immune CAR-T candidates like CTX112 [1] - The company is positioned to attract significant opportunities for its next growth curve with its in vivo technologies targeting ANGPTL3 and Lp(a), especially in the context of the pharmaceutical industry's heightened focus on cardiovascular targets [1] Industry Summary - The pharmaceutical industry is currently placing a strong emphasis on cardiovascular targets, which aligns with CRISPR's strategic focus and resource allocation, allowing it to navigate challenges faced by some of its gene editing peers [1]

Core Insights - The company, Baiaosaitu, has secured two significant licensing agreements within a month, highlighting the value of its proprietary RenMice fully human antibody development platform [1][2] - The company has established itself as a leader in the innovative molecular licensing space in China, with a total of 280 licensing projects, including partnerships with seven of the top ten global pharmaceutical companies [2][3] Group 1: Licensing Agreements - On September 16, Baiaosaitu signed an antibody licensing agreement with Tubulis, which will utilize Baiaosaitu's RenMice platform for developing innovative ADC therapies [1] - Just over a week prior, on September 4, Baiaosaitu entered into an antibody option and evaluation agreement with Merck to assess antibodies developed using the RenMice platform [1] - These agreements demonstrate the international competitiveness and drug conversion potential of Baiaosaitu's fully human antibody platform [1] Group 2: Financial Performance - In the first half of the year, Baiaosaitu achieved a revenue of 621 million yuan, representing a year-on-year growth of over 51% [2] - The company's gross margin remained high at approximately 74.4%, with a net profit of 48 million yuan [2] - The stock price of Baiaosaitu increased significantly, from a low of 7.8 HKD per share to a high of 28.58 HKD per share, reflecting a growth of over 320% since the beginning of the year [2] Group 3: Research and Development - Baiaosaitu's R&D expenses for the first half of the year were approximately 209 million yuan, an increase of 29.3% year-on-year [4] - The company has obtained 195 authorized patents and submitted 496 patent applications, focusing on expanding its fully human antibody library [4] - Baiaosaitu aims to enhance its core advantages in target humanized mouse and fully human antibody discovery by integrating AI and automation into its R&D processes [4]

Core Insights - The 2025 China International Service Trade Fair (CIFTIS) commenced in September in Beijing, featuring a forum on "Innovations in Tumor Treatment and New Trends in Drug Development" as a key academic activity [1] - The forum aims to create a high-end communication platform for policy interpretation, results release, industry connection, and international cooperation in the field of tumor prevention and treatment [1][3] Group 1: Forum Objectives and Themes - The forum is centered around the theme "Gathering Global Wisdom to Build a New Future in Cancer Prevention" and focuses on promoting disease prevention research and accelerating the transformation of scientific achievements [3] - The event emphasizes the importance of collaboration among government, industry, academia, and research institutions to enhance tumor prevention and treatment [3][4] Group 2: Scientific and Technological Innovations - Keynote speakers highlighted that technological innovation is crucial for the development of precision medicine in oncology, integrating multi-omics technologies, gene editing, liquid biopsy, and artificial intelligence [4] - The proportion of innovative drugs in development, such as cell therapy and bispecific antibodies, has reached 39% in China, marking a significant shift from generic to innovative drug development [4] Group 3: Challenges and Solutions in Cancer Treatment - Experts discussed the challenges in cancer prevention, including low HPV vaccination rates and insufficient screening coverage, particularly in remote areas and among young women [5][6] - A new model for cervical cancer prevention and control was presented, focusing on a multi-dimensional approach that includes immunology, protein, and gene strategies [6] Group 4: Collaborative Research Initiatives - The forum witnessed the launch of a strategic cooperation agreement for a research project aimed at establishing a standardized system for clinical applications of tumor biotherapy [6] - The project involves multiple institutions and aims to create technical standards and clinical pathways to facilitate the safe and compliant transformation of cutting-edge technologies in the industry [6]

Investment Rating - The report does not explicitly state an investment rating for the industry [1] Core Insights - The domestic biopharmaceutical innovation is expected to accelerate, driven by the approval of the "Regulations on the Management of Clinical Research and Clinical Translation Applications of Biomedical New Technologies (Draft)" by the State Council on September 12 [2][12] - The report highlights the importance of promoting biomedical technology innovation and the need for regulatory frameworks to ensure safety and quality in clinical applications [2][12] - The report expresses optimism towards companies focusing on new biomedical technologies, particularly in areas such as gene editing, cell therapy, and stem cell research [2] Weekly Market Review - The biopharmaceutical sector experienced a decline of 0.36% from September 8 to September 12, underperforming compared to the Wind All A index (2.12%) and the CSI 300 index (1.38%) [7] - Among sub-sectors, medical devices (3.02%), in vitro diagnostics (2.0%), and pharmaceutical distribution (1.44%) showed the highest gains, while chemical preparations (-2.83%), raw materials (-1.06%), and blood products (-0.72%) faced the largest declines [7][8] - Notable stock performances included Zhend Medical (41.3%), Haooubo (28.0%), and Jimin Health (25.9%) with significant gains, while Yuekang Pharmaceutical (-18.4%), Maiwei Biotech-U (-14.4%), and Yirui Biotech (-14.0%) saw substantial losses [10] Industry News and Key Company Announcements - The report mentions significant events such as the collaboration between Shiyao Group and Kangning Jiere to develop a new drug for HER2-positive gastric cancer, which has been accepted for review by the National Medical Products Administration [12] - The report also notes the approval of a new drug by Johnson & Johnson for treating non-muscle invasive bladder cancer, marking a significant advancement in bladder cancer treatment [14] - BioNTech and Bristol Myers Squibb reported promising mid-term data for their bispecific antibody in treating extensive-stage small cell lung cancer, showing an objective response rate of 76.3% [14]

Group 1 - The core focus of the research is on accelerating the construction of an international green economy benchmark city in Beijing, enhancing its international influence in the green economy sector [1] - The research team visited the Beijing Synthetic Biology Manufacturing Industry Cluster and engaged with company leaders to understand the city's resource advantages, industry planning, cutting-edge technologies, and innovative achievements in synthetic biology manufacturing [1] - The committee emphasized the importance of cultivating the synthetic biology manufacturing industry as a key initiative for Beijing's development as an international green economy benchmark city, suggesting the creation of a highly collaborative innovation ecosystem involving government, industry, academia, and research [1] Group 2 - The research team also visited North China Electric Power University, exploring key laboratories related to new energy power systems and semiconductor device reliability, while acknowledging the university's role in training high-quality talent for the energy sector [2] - The emphasis was placed on aligning educational programs with national strategic development needs to foster leadership talent and enhance technological innovation capabilities in the energy and power sectors [2] - The city government expressed its commitment to supporting the university's high-quality development to further contribute to the construction of an international green economy benchmark city [2]

Core Viewpoint - The research led by Sana Biotechnology offers a potential breakthrough in treating Type 1 Diabetes (T1D) by enabling the survival of transplanted allogeneic beta cells without the need for immunosuppression, which could significantly improve patient outcomes and reduce the risks associated with long-term immunosuppressive therapy [2][4][7]. Group 1: Research Findings - A study published in NEJM demonstrated that CRISPR-Cas12b gene editing was used to modify donor beta cells to avoid immune rejection, allowing these cells to be transplanted into a Type 1 Diabetes patient without immunosuppressive drugs [2][4]. - The patient showed no immune response to the transplanted cells within 12 weeks, and the cells continued to produce insulin, effectively regulating blood sugar levels [2][9]. - This approach represents a significant advancement towards achieving a long-term cure for T1D, with the potential for a one-time treatment that eliminates the need for insulin injections and immunosuppressive medications [9][10]. Group 2: Comparison with Other Companies - Other companies, such as Vertex and Reprogenix, are also exploring stem cell-derived therapies for T1D, but these methods still require immunosuppressive drugs to prevent immune attacks on either donor or patient-derived cells [6][7]. - Vertex's research involved transplanting stem cell-derived islets into 12 patients, with 10 no longer needing insulin after one year, while Reprogenix successfully reprogrammed patients' own fat cells into insulin-producing cells [6][7]. - Unlike these approaches, Sana's method aims to eliminate the need for immunosuppression entirely, which could revolutionize treatment for T1D [7][9]. Group 3: Future Directions and Challenges - The ultimate goal of Sana's research is to apply the "immune stealth" gene editing technique to stem cells, guiding their development into insulin-secreting beta cells, with clinical trials expected to begin next year [9][10]. - However, there are concerns regarding the reproducibility of the protective effects of CD47 and the limited scope of the initial study, which involved only one patient and a small number of transplanted cells [10].