Core Insights - The Chinese innovative pharmaceutical industry is undergoing a historic transformation, shifting from "fast followers" to "original creators" supported by solid data and market performance [1] - By 2025, the total value of innovative drug licensing transactions in China is expected to exceed $130 billion, with over 150 transactions, marking a historical high [1] - Shanghai's Pudong district is becoming a key hub for the global market, with significant achievements in CAR-T products and first-class new drugs [1] Industry Overview - China's pharmaceutical industry ranks second globally, with approximately 30% of innovative drugs in development worldwide [1] - The industry is entering a critical phase characterized by "innovation realization + global layout" [1] Company Developments - Chinese innovative drug companies are leveraging speed and cost-effectiveness to gain a competitive edge in the global market [3] - Companies like Maiwei Biotech and Jinsai Pharmaceutical are forming significant overseas business development (BD) partnerships, enhancing China's global competitiveness [3][4] - Maiwei Biotech has accelerated its BD efforts, securing exclusive licensing agreements for innovative therapies, including a $1 billion potential deal with Aditum Bio [4][5] Market Trends - By 2025, Pudong is expected to have approved four CAR-T products, accounting for 30% of the global total, and seven first-class new drugs, representing 14% of the national total [1] - The commercial sales of innovative drugs in Pudong are projected to exceed 11.6 billion yuan in 2024, with several new drugs achieving over 1 billion yuan in annual sales [10] Strategic Initiatives - Companies are focusing on building comprehensive global capabilities covering research, registration, and sales to transition from "licensing out" to "commercialization abroad" [10] - Jinsai Pharmaceutical has established local teams in the U.S. and Europe to manage clinical trials and seek collaboration opportunities [8] Innovation and Collaboration - The future of innovative drugs lies in international markets, with companies emphasizing deep understanding of disease biology as a core competitive advantage [5] - Companies are forming cooperative committees with BD partners to ensure project progress through information sharing and resource collaboration [5] Ecosystem Support - The rise of China's innovative drug industry is attributed to years of policy guidance, technological accumulation, and capital cultivation [23] - The unique industrial atmosphere, talent pool, and complete industrial chain in Zhangjiang are seen as core advantages for local companies [23][24] - Pudong's talent policies and supportive platforms are facilitating the rapid gathering of global talent resources [23] Future Outlook - The next 3-5 years are expected to see continued emphasis on internationalization and globalization among Chinese biopharmaceutical companies [14] - Companies are increasingly focusing on source innovation and high-quality BD potential to meet global market demands and achieve high valuations [17]

记者丨韩利明 编辑丨陶力 当前我国创新药产业正迎来历史性转折——历经多年在研发、监管、资本与供应链上的厚积 薄发，行业正实现从"快速追随者"向"源头首创者"的进阶跨越。 这背后有着扎实的数据与市场表现支撑：当前中国医药产业规模已位居全球第二，创新药在 研数目约占全球的30%；2025年我国创新药对外授权交易总金额超过1300亿美元，授权交易 数量超过150笔，均创历史新高。中国医药资产在全球范围内性价比与竞争力的提高，正推动 行业迈入"创新兑现+全球布局"的关键阶段。 而在全国生物医药创新版图中，上海浦东创新药海外布局按下"快进键"，成为国内生物医药 产业对接全球市场的核心枢纽。数据显示，2025年，浦东已获批4款CAR-T产品、占全球 30%；获批7款1类新药、占全国14%；BD（商务拓展）交易金额204亿美元、占全球14%。 从"中国新"到"全球新"的每一步跨越，都在见证中国创新药产业从量变积累迈向质变突破的加 速时刻。这一进程离不开成熟完善的产业生态作为坚实后盾，为中国创新药的全球化征程保 驾护航。 中国创新药海外"圈粉" 在全球医药市场竞争中，中国创新药正凭借"速度×成本效益"双重优势崭露头角。在确定 ...

Market Overview - The A-share pharmaceutical and biotechnology index fell by 1.17%, underperforming the CSI 300 index by 2.44 percentage points and the ChiNext index by 1.89 percentage points, ranking 17th among 31 sub-industries [4] - The H-share Hang Seng Healthcare Index also declined by 0.71%, lagging behind the Hang Seng Index by 1.45 percentage points [4] R&D Progress - Recent IND applications include Yifang Biotech's D-0502 tablets and Hengrui Medicine's HRS-6257 tablets; clinical applications include BeiGene's BG-C137 injection and Hengrui's HRS-4642 [5] - Shijiazhuang Pharmaceutical's SYS6002 and Zai Lab's Epcoritamab are in Phase III clinical trials; Maiwei Biotech's 9MW3811 is in Phase II; and 3SBio's SSGJ-709 is in Phase I [5] Policy and Market Developments - On December 7, the National Healthcare Security Administration released the new National Basic Medical Insurance Drug Directory and the Commercial Health Insurance Innovative Drug Directory for 2025, with 127 products participating in negotiations, of which 114 were successfully included, achieving a success rate of 88%, the highest in seven years [6] - The first commercial insurance directory included 24 drugs, with 19 successfully negotiated, including CAR-T therapies and treatments for rare diseases such as neuroblastoma and Gaucher disease, as well as Alzheimer's disease [6] - The implementation of the commercial insurance innovative drug directory is expected to open broader market opportunities for innovative drugs in the context of a growing number of "global new" drugs emerging in China [6] Investment Strategy - The investment strategy for the pharmaceutical sector is shifting towards emphasizing the clinical value of drugs, addressing clinical needs of patients, influenced by domestic healthcare policies and global expansion [7] - The focus is on the innovative drug supply chain and innovative medical devices, reflecting a clinical value-based investment approach [7]

Core Insights - Maiwei Biotech has received approval from the National Medical Products Administration (NMPA) for its IL-11 monoclonal antibody 9MW3811 to enter Phase II clinical trials for pathological scars, marking it as the first drug targeting this indication in clinical exploration [1] - The company has established an exclusive licensing agreement with CALICO Life Sciences, which includes an upfront payment of $25 million and potential milestone payments totaling up to $571 million, along with tiered royalties based on net sales [1][2] - Maiwei Biotech reported a significant revenue increase of 301.03% year-on-year, reaching 566 million yuan in the first three quarters of 2025, driven primarily by income from innovative product collaborations [2] Group 1: Clinical Development and Partnerships - The company has a comprehensive pipeline with 15 core products at various stages, including 11 innovative drugs and 4 biosimilars, focusing on oncology and age-related diseases [2] - The Phase II clinical trial for the anti-TMPRSS6 monoclonal antibody 9MW3011 has commenced, with the first patient dosed in the U.S., marking a significant milestone in its collaboration with DISC Medicine [3] - Maiwei Biotech has entered into a partnership with Qilu Pharmaceutical for long-acting white blood cell-boosting drugs, with a contract value of up to 500 million yuan, including a non-refundable upfront payment of 380 million yuan [4] Group 2: Financial Performance - The substantial increase in technical service revenue is attributed to the licensing agreements with CALICO, Qilu, and DISC, indicating the successful commercialization of innovative research [4] - The company’s revenue from technical services reached 407 million yuan, a year-on-year increase of 715.52%, while drug sales contributed 156 million yuan, reflecting a 72.10% increase [2] - Maiwei Biotech's ongoing clinical trials for its core pipeline products, including 9MW2821 and JS207, show promising efficacy signals in treating triple-negative breast cancer [5]

Policy Developments - Jiangxi Province is promoting the development of brain-computer interface medical devices, emphasizing the need for regulatory compliance and collaboration among industry players to seize opportunities in emerging technologies [1] - The market for brain-computer interface medical devices is noted to have significant potential, with a strong development momentum in Jiangxi Province [1] Medical Device Approvals - In October, the National Medical Products Administration approved 204 medical device products, including 173 domestic Class III devices, 10 imported Class III devices, and 21 imported Class II devices [2] Pharmaceutical Logistics - The Shanghai Municipal Drug Administration encourages the development of modern pharmaceutical logistics, advocating for improved storage and management systems to enhance operational efficiency and reduce costs [3] Drug Approvals - Fangsheng Pharmaceutical announced that its Indobufen tablets received a drug registration certificate from the National Medical Products Administration, allowing for production [4] - Saito Bio's application for the chemical raw material drug Mometasone Furoate has been approved, indicating its use in treating asthma and skin conditions [5] - Tianyao Pharmaceutical received a drug registration certificate for Metoclopramide injection, which is used for treating nausea and vomiting [6] Capital Market Activities - Yingsi Intelligent submitted a listing application to the Hong Kong Stock Exchange, aiming to raise funds for its AI-driven drug development initiatives [7][8] - Rejuve Bio plans to repurchase shares worth between 100 million and 200 million yuan to support employee stock ownership plans [9] Industry Developments - AstraZeneca's Baxdrostat demonstrated significant reductions in 24-hour average systolic blood pressure in treatment-resistant hypertension patients during the Bax24 Phase III trial, achieving a reduction of 14.0 mmHg compared to placebo [10][11] - The drug showed good overall tolerability and consistent safety profiles, with a notable percentage of patients achieving target blood pressure levels [11] - Maiwei Bio's IL-11 monoclonal antibody 9MW3811 received approval for Phase II clinical trials targeting pathological scars, marking it as the first IL-11 targeted drug to enter clinical trials for this indication [12] - Aiwei Technology's subsidiary obtained a medical institution practice license, enabling it to provide third-party medical testing services [13] - Anke Bio signed an exclusive agency framework agreement with Boshengji for the PA3-17 injection product, aimed at enhancing its product portfolio in the innovative drug market [14][15]

Core Insights - Wuhan Heyuan Biotechnology Co., Ltd. is set to become the first incremental enterprise in the Sci-Tech Innovation Board's growth layer, focusing on innovative drug development, particularly the "rice blood" technology [1] - The Sci-Tech Innovation Board has supported 13 innovative drug companies with a total market capitalization of nearly 500 billion, leading to the approval of 25 new drugs since its inception [1][4] - The introduction of the fifth set of listing standards has allowed unprofitable companies to access capital markets, significantly boosting the innovative drug sector in China [2] Industry Development - Since 2019, China's innovative drug industry has raised over 1 trillion in financing across primary and secondary markets, leading to unprecedented activity in drug research and development [2] - China's innovative drug R&D pipeline accounts for approximately 25% of the global total, surpassing the number of active innovative drugs in the U.S. [2] - The establishment of the "growth layer" in the Sci-Tech Innovation Board aims to enhance support for technology innovation and has been pivotal for companies like Suzhou Zelgen Biopharmaceuticals, which has successfully launched three new drugs since listing [2] R&D Investment and Performance - High R&D investment is a key reason for the lack of profitability among companies in the growth layer, but it is also a critical driver for future innovation [3] - BeiGene, a leading innovative drug company, is projected to invest 14.1 billion in R&D in 2024, maintaining its position as the top R&D spender on the Sci-Tech Innovation Board [3] - BeiGene's drug, Zebrutinib, has achieved significant global sales, generating 1.3 billion in revenue in the first half of the year, with a year-on-year growth of over 56% [3] Financial Performance - The innovative drug companies in the growth layer are transitioning from R&D investment to commercialization, with a combined revenue of 31.9 billion expected in 2024, reflecting a year-on-year growth rate of 54.39% [5] - The annual compound growth rate of these companies' revenue since 2019 is 52.33%, significantly outpacing the growth rate of other sectors [5][6] - Innovent Biologics reported a net profit of 3.7 billion after its IPO, driven by a strategic partnership with Bristol-Myers Squibb, which included an upfront payment of 800 million [4] International Collaboration and Market Recognition - The innovative drug companies have engaged in international collaborations, with potential transaction values nearing 5 billion, indicating strong global market recognition [7] - Companies like Innovent Biologics and Nocera have secured licensing agreements with international firms, further validating the strength of China's innovative drug sector [7]

Core Insights - He Yuan Bio, the world's first company to innovate "rice hematopoiesis," will debut on the Sci-Tech Innovation Board, becoming the first incremental enterprise in the Sci-Tech Growth Layer [1] - The Sci-Tech Growth Layer currently has 13 innovative pharmaceutical companies with a total market value of nearly 500 billion, having facilitated the approval of 25 new drugs since their listing [1] Group 1: Institutional Reform and Investment Trends - The establishment of the fifth set of listing standards on the Sci-Tech Innovation Board has allowed unprofitable companies to go public, significantly aiding innovative pharmaceutical companies in overcoming funding bottlenecks and accelerating drug development [2] - Since 2019, the cumulative financing scale of China's innovative pharmaceutical industry in both primary and secondary markets has exceeded 1 trillion [2] - The R&D pipeline of China's innovative drugs accounts for approximately 25% of the global total [2] Group 2: R&D and Commercialization Acceleration - High R&D investment is the main reason for the current unprofitability of companies in the Sci-Tech Growth Layer, but it is also the key driver for future innovation development [3] - In 2024, the total revenue of these innovative pharmaceutical companies is expected to reach 31.9 billion, with a year-on-year growth rate of 54.39% [3] - These companies have successfully launched 20 new drugs with "global new" attributes and achieved "breakthrough therapy" designation for 10 innovative drugs across 17 indications [3] Group 3: Leading Companies and Market Performance - Innovative pharmaceutical leader BeiGene has achieved a "qualitative leap" through a combination of "hardcore technology and commercialization breakthroughs," with R&D investment reaching 14.1 billion in 2024 [4] - BeiGene's core product, Zebrutinib, has been approved in over 70 countries and regions, benefiting 180,000 patients, with a half-year sales revenue of 1.3 billion, a year-on-year increase of over 56% [4] - BeiGene expects to exceed 35 billion in total revenue by 2025, entering a positive cycle of "R&D breakthroughs—product volume—profit realization" [4] Group 4: International Market Engagement - Several companies in the Sci-Tech Growth Layer have actively pursued international transactions this year, with a potential total transaction amount of nearly 5 billion [5] - For instance, Maiwei Bio has reached an exclusive licensing agreement with Calico, including a potential transaction total of 596 million [5] - Nocera Jianhua has announced a licensing agreement with Zenas BioPharma, expecting a total transaction amount exceeding 2 billion [5]

Core Viewpoint - He Yuan Bio, a pioneer in "rice hematopoiesis" innovative drugs, will debut on the Sci-Tech Innovation Board, marking it as the first incremental enterprise in the Sci-Tech Growth Layer [1] Group 1: Institutional Reform and Investment Trends - The fifth set of listing standards on the Sci-Tech Innovation Board has enabled companies without revenue or profits to go public, facilitating funding for innovative drug companies and spurring an investment boom in the sector [3] - Since 2019, the cumulative financing scale of China's innovative drug industry in both primary and secondary markets has exceeded 1 trillion yuan, leading to a surge in R&D activities [3] - The establishment of the "Sci-Tech Growth Layer" aims to enhance the adaptability and inclusiveness of the Sci-Tech Innovation Board, supporting the development of new productive forces and technological innovation [3] Group 2: R&D Investment and Commercialization - High R&D investment is the main reason for the current lack of profitability among innovative drug companies in the Sci-Tech Growth Layer, but it is also the key driver for future acceleration in innovation [5] - In 2024, the total revenue of these companies is expected to reach 31.9 billion yuan, with a year-on-year growth rate of 54.39%, significantly outpacing the average compound growth rate of the sector [5] - These companies have successfully launched 20 new national Class 1 drugs with "global new" attributes and achieved breakthrough therapy designations for 10 innovative drugs across 17 indications [5] Group 3: Market Recognition and Future Prospects - Innovative drug leaders like BeiGene have achieved significant milestones, including a projected revenue of over 35 billion yuan in 2025 and a positive operating profit, entering a virtuous cycle of R&D breakthroughs and product commercialization [6] - Several companies in the Sci-Tech Growth Layer have engaged in international transactions, with potential total transaction amounts nearing 5 billion dollars, indicating strong international market recognition [6] - Notable agreements include a licensing deal between Maiwei Bio and Calico, with a potential total of 596 million dollars, and a partnership between Nuocheng Jianhua and Zenas BioPharma, expected to yield over 2 billion dollars [6]

Core Insights - The company is strategically expanding into the small RNA platform to address age-related chronic diseases, aiming to develop a pipeline with long-term value and transition into a Pharma company [1][2]. Group 1: Company Overview - The company has established a partnership with AditumBio to form KalexoBio, focusing on a dual-target siRNA drug, 2MW7141, for cardiovascular diseases, with a total deal value of $1 billion [2]. - The company has a strong asset management background, with the fund managing assets of 16.182 billion yuan and achieving a one-year return of 54.74% for its best-performing fund [1]. Group 2: Product Development - The dual-target siRNA drug 2MW7141 is designed to address unmet clinical needs in cardiovascular treatment, with preliminary data showing strong efficacy in animal models [3][5]. - The siRNA technology platform emphasizes differentiated innovation, utilizing AI for automated design and screening, and optimizing delivery methods for both liver-targeted and extrahepatic applications [4]. Group 3: Research and Clinical Trials - The α-synuclein-targeting PET tracer [18F]-FD4 has received funding from the Michael J. Fox Foundation to accelerate its development for Parkinson's disease and related disorders, with potential for early diagnosis and monitoring [6][7]. - The company is advancing multiple clinical pipelines, including 9MW2821 for bladder cancer and 9MW1911 for COPD, with significant milestones expected in the coming years [8][9].

Investment Rating - The investment rating for the company is "Buy" (maintained) [7] Core Insights - The company reported a 2025 H1 revenue of 101 million yuan, a year-on-year decrease of 12.43%, with a net profit attributable to the parent company of -551 million yuan. However, drug sales revenue reached 100 million yuan, showing a significant year-on-year growth of 53.50%, which is the main growth driver [5][13] - The long-acting G-CSF drug, Mai Li Sheng®, was approved for market release, and a new drug technology license agreement worth 500 million yuan was signed with Qilu Pharmaceutical. Additionally, the company granted CALICO exclusive rights to develop, produce, and commercialize IL-11 targeted therapy products outside Greater China, receiving an upfront payment of 25 million USD, with potential milestone payments up to 571 million USD [5][14] Summary by Sections Financial Performance - In 2025 H1, the company achieved a revenue of 101 million yuan, a decrease of 12.43% year-on-year, while the drug sales revenue was 100 million yuan, increasing by 53.50% [5][13] - The company is expected to see revenues of 677 million, 1.484 billion, and 3.260 billion yuan for the years 2025, 2026, and 2027, respectively, with year-on-year growth rates of 238.86%, 119.25%, and 119.65% [15][16] Research and Development - The company has increased its R&D expenditure by 21.72% year-on-year, focusing on advancing clinical trials and key registration clinical research phases. As of 2025 H1, the company has 10 innovative drugs and 4 biosimilars in its pipeline, including ADCs and monoclonal antibodies [14] Market Position and Future Outlook - The company is positioned to benefit from the approval of innovative drugs and the gradual market release of biosimilars. The expected net profit attributable to the parent company is projected to improve from -859 million yuan in 2025 to -40 million yuan in 2027 [15][16]