格隆汇12月9日｜国海证券发表研究报告指，基于TransCon技术的长效生长激素隆培预计上市在即，其 相比于短效人生长激素显示出优效性及同等安全性。隆培生长激素为维昇药业于2018年11月自Ascendis Pharma授权引入，凭借TransCon（暂时连接技术）长效路径，隆培生长激素是唯一一款于每周给药之间 在体内持续释放未经修饰的人生长激素的长效生长激素，经已完成的中国Ⅲ期关键性试验所验证，隆培 生长激素是唯一一款在与短效人生长激素的阳性药物对照及平行组试验比较中显示出优效性及同等安全 性的长效生长激素。根据维昇药业公告，预计隆培生长激素于2025年四季度在国内获批上市，建议近期 重点关注维昇药业。 ...

Group 1: Company Overview and Leadership - Anke Bioengineering has strategic partnerships with companies like Boshengji, Afana, and Yuansong Bio, focusing on innovative drug development and commercialization [3][4][5][6] - The leadership team includes Chairman and President Song Lihua, Vice Chairman Zhou Yuanyuan, and several vice presidents overseeing various departments [2][3] Group 2: Research and Development Highlights - Boshengji's CAR-T PA3-17 has entered critical clinical trial phases, aiming for full patient enrollment by Q1 2027 and pre-NDA communication submission [3] - Yuansong Bio's lead product, recombinant L-IFN adenovirus injection, has progressed to Phase IIa clinical trials in China [5] - Afana has received clinical trial approvals for six Class I new drugs, focusing on autoimmune diseases and mRNA therapies, with significant advancements in CAR-T and HPV treatments [6][7] Group 3: Product Pipeline and Market Strategy - The company is advancing a long-acting growth hormone, expected to be approved by the end of 2025, with a focus on leveraging its commercial capabilities [4][8] - The long-acting follicle-stimulating hormone has begun market entry, with ongoing efforts to establish partnerships with private hospitals for sales [9] - The dual-target Her2 and PD-L1*4-1BB antibodies are in clinical development, with plans for IND submission in 2027 [10][11] Group 4: Financial and Market Positioning - The company aims to maintain stable growth in its traditional business while expanding into innovative drug markets [11] - Strategic focus on optimizing product structure and enhancing market competitiveness through accelerated commercialization and R&D capabilities [11] - The company is developing a comprehensive 3, 5, and 10-year strategic plan to address market challenges and enhance its positioning in the capital market [11]

Core Viewpoint - Weisheng Pharmaceutical-B (02561) experienced a significant increase of over 4% in stock price, reaching HKD 34.98 with a trading volume of HKD 966,400, following strategic partnerships announced during the 8th China International Import Expo [1] Group 1: Strategic Partnerships - Weisheng Pharmaceutical entered into a strategic cooperation for dual-chamber freeze-dried formulation technology with Dongfulong (300171), a leading domestic pharmaceutical equipment company [1] - The company also signed an industrial collaboration agreement with the Lingang New Area Administrative Committee and Lingang Group's trade platform, further implementing its strategy of "Global Innovation, China Acceleration" [1] Group 2: Product Showcase - This year marks Weisheng Pharmaceutical's debut as an exhibitor at the 8th China International Import Expo, showcasing two globally innovative drugs [1] - Among the showcased products, Parathyroid hormone replacement therapy is the world's first and only drug for treating adult chronic hypoparathyroidism (HP) [1] - The company also presented Longpei growth hormone, which aims to become a "potential best-in-class" drug [1]

Core Viewpoint - Vison Pharma-B (02561) experienced a significant stock increase of over 4%, closing at HKD 34.98 with a trading volume of HKD 966,400, following strategic partnerships announced during the 8th China International Import Expo [1] Group 1: Strategic Partnerships - Vison Pharma has entered into a strategic cooperation for dual-chamber lyophilized formulation technology with Dongfulong, a leading domestic pharmaceutical equipment company [1] - The company also signed an industrial collaboration agreement with the Lingang New Area Administrative Committee and Lingang Group's trade platform, furthering its strategy of "Global Innovation, China Acceleration" [1] Group 2: Product Launches - This year marks Vison Pharma's debut as an exhibitor at the 8th China International Import Expo, showcasing two globally innovative drugs [1] - Among the showcased products, Parathyroid hormone replacement therapy is the world's first and only drug for treating adult chronic hypoparathyroidism, while another product aims to become a "potential best-in-class" growth hormone [1]

Core Viewpoint - The core logic of the company is defined as focusing on product implementation and patient benefits rather than mere concepts [1] Group 1: Company Achievements and Innovations - The company made a significant debut at the China International Import Expo, showcasing three major achievements: the launch of the first domestic dual-chamber lyophilized preparation production line in collaboration with Dongfulong, the selection of Parathyroid hormone as a "good product" at the expo, and the imminent approval of Longpei growth hormone [1][2] - The dual-chamber lyophilized preparation technology is seen as a key solution to the industrialization bottleneck in high-end biopharmaceuticals, enhancing patient compliance [3][4] - The company aims to leverage the expo platform to connect with global innovation resources and attract more overseas technologies and products, enriching its endocrine disease product pipeline [2] Group 2: Market Potential and Product Development - Parathyroid hormone is positioned as a groundbreaking treatment for patients with parathyroid hormone deficiency, with the potential to become the first and only hormone replacement therapy for this condition globally [5] - The company has received approvals from major regulatory bodies, including the EMA, MHRA, and FDA, and plans to launch the product in China by September 2025 [5] - Longpei growth hormone is designed with a focus on "technological innovation" and "patient-friendly" features, adhering to high production standards to build trust among families [6][7] Group 3: Strategic Collaborations and Future Plans - The collaboration with Dongfulong is not only about technology implementation but also enhances the company's ability to control key production processes and establish a local commercial production layout [4] - The company is adopting a "dual-track" model for market entry, initially importing products to meet demand before launching domestically produced versions by 2028 [8] - The company is focused on building a collaborative ecosystem with high-end equipment manufacturers, CDMO partners, and specialized channels to ensure efficient product development and commercialization [11][12] Group 4: Growth Strategy and Market Trends - The company's growth strategy emphasizes deepening its focus on the endocrine field, targeting clinically urgent needs and leveraging local technological innovations to create competitive advantages [14] - The Chinese growth hormone market is expected to transition to long-acting products, with long-acting therapies projected to capture 90% of the market share in a market valued at billions [15] - The company aims to provide high-quality treatment options for patients, ensuring that innovative drugs are developed to meet global standards [15]

Core Insights - The eighth China International Import Expo (CIIE) concluded successfully, showcasing numerous achievements and opportunities for first-time exhibitors across various sectors, including industrial technology, biomedicine, new materials, cross-border trade, and regenerative medicine [1] Group 1: Market Opportunities - First-time exhibitors leveraged their technological advantages to align with China's development needs, which is crucial for market entry [2] - INXPECT SPA presented its SIL-certified safety radar system, addressing safety challenges in automated production, aligning with China's shift towards high-end, intelligent manufacturing [2] - Three Mars High Tech International Limited showcased high-performance magnesium alloy forged wheels, enhancing electric vehicle range, thus capitalizing on the industry's lightweight trend [4] - Weisheng Pharmaceutical, nearing commercialization with its growth hormone for children, aims to tap into China's vast unmet medical needs, with plans for market entry by early 2026 [5] Group 2: Ecosystem Building - The CIIE serves as a platform for connecting upstream and downstream industry players, facilitating the transformation of exhibits into commercial products [6] - Weisheng Pharmaceutical transitioned from an observer to an independent exhibitor, achieving significant partnerships during the expo, highlighting the event's role in resource integration [6] - Three Mars International utilized a "mother-son synergy" model to establish connections across various sectors, enhancing collaboration opportunities within the supply chain [9] Group 3: Cross-Border Trade - The CIIE provides a platform for cross-border collaboration, enabling companies to explore both "entering China" and "expanding out of China" strategies [10] - Melonise Group facilitated the entry of leading Turkish companies into the Chinese market, enhancing trade relations and identifying local demand for Turkish products [12] - INXPECT SPA aims to introduce European industrial safety technologies to China while leveraging the market's scale to expand throughout the Asia-Pacific region [13]

Core Insights - The healthcare industry is demonstrating remarkable resilience in response to changing times, with a projected global market growth of 9% in 2024 driven by innovations in specialized treatments, explosive growth in anti-obesity drugs, and widespread application of AI in healthcare [1] - The China International Import Expo (CIIE) serves as a vital platform for global pharmaceutical companies to integrate deeply with the Chinese market and advance the Healthy China strategy [1][2] Industry Trends - The Chinese government has introduced policies to develop the healthcare industry and encourage innovative drug research, positioning China as a potential global center for biopharmaceutical innovation [2] - Major chronic diseases, such as cardiovascular and chronic kidney diseases, pose significant public health challenges in China, with over 400 million patients affected [2] Innovations and Product Launches - At the CIIE, various pharmaceutical companies showcased innovations across multiple fields, including cardiovascular, metabolic, respiratory, and oncology, highlighting their commitment to addressing major health challenges [1] - Novartis introduced the "Heart and Kidney Guardian Evidence-Based Science Popularization" project, emphasizing the dual role of pharmaceutical companies in drug development and public health education [3] - Sanofi launched two innovative cardiovascular drugs, Aficamten and Plerixafor, at the CIIE, addressing unmet patient needs in the treatment of cardiovascular diseases [3] - Roche presented advancements in blood cancer treatments, including new indications for existing therapies and innovative products for hemophilia [5] Strategic Collaborations - Siemens Healthineers and Novartis signed a strategic cooperation agreement to advance the integration of radioligand therapy and molecular imaging systems for precision treatment of diseases like prostate cancer [19] - Novo Nordisk and the Shanghai Clinical Innovation and Translation Research Institute (ACITS) established a strategic partnership to enhance clinical research and innovation in China [16][17] Public Health Initiatives - The CIIE featured discussions on the application of digital technology and AI in public health, aligning with China's "Healthy China 2030" strategy [21][23] - Pfizer emphasized the role of big data and AI in transforming public health systems and achieving health goals in China [23] Emerging Companies and Products - Viseon Pharmaceuticals showcased two innovative drugs at the CIIE, highlighting its commitment to global innovation and rapid market entry in China [24]

Core Insights - The strategic cooperation between Weisheng Pharmaceutical and Dongfulong Technology Group focuses on the development and application of dual-chamber lyophilized formulation technology, which aims to enhance the stability and usability of injectable biologics [2] Group 1: Company Developments - Weisheng Pharmaceutical made its debut as an exhibitor at the 8th China International Import Expo, showcasing two globally innovative drugs, including the world's first hormone replacement therapy for adult chronic hypoparathyroidism, Paratide [1] - The second drug presented is Longpei Growth Hormone, which is expected to receive approval from the National Medical Products Administration of China by the end of 2023 [1] Group 2: Strategic Partnerships - The collaboration with Dongfulong aims to address the challenges of stability and convenience in high-end biologics, with the dual-chamber technology allowing for easy preparation of injectable drugs [2] - This partnership is expected to fill a technological gap in China, providing an advanced drug delivery solution [2]

Core Insights - Weisheng Pharmaceutical made its debut as an exhibitor at the 8th China International Import Expo, showcasing two global innovative drugs: the "world's first" drug Parathyroid Hormone (PTH) and the "potential best-in-class" drug Long-acting Growth Hormone [1][2] Group 1: Product Innovations - Parathyroid Hormone (PTH) is the first and only hormone replacement therapy for adult chronic hypoparathyroidism (HP), filling a long-standing gap in China's treatment options and breaking decades-long treatment deadlock [2] - PTH has received marketing approvals from the European Medicines Agency (EMA), the UK Medicines and Healthcare products Regulatory Agency (MHRA), and the US Food and Drug Administration (FDA) [2] - The application for Long-acting Growth Hormone is under review by the National Medical Products Administration of China, with approval expected in 2025, potentially providing a new treatment option for children with growth hormone deficiency [2] Group 2: Strategic Collaborations - Weisheng Pharmaceutical signed a strategic cooperation agreement with Dongfulong Technology Group, focusing on the development and application of dual-chamber lyophilized formulation technology [3] - This technology allows for the physical separation of the drug and diluent in a closed container, simplifying the preparation process for injections [3] - The collaboration aims to fill a technological gap in China's high-end biopharmaceutical sector and provide advanced drug delivery solutions [3] Group 3: Commitment to Market - Weisheng Pharmaceutical is committed to accelerating the industrialization of its global first products, including Long-acting Growth Hormone and Parathyroid Hormone, to enhance endocrine treatment levels in China [3] - The company aims to ensure that more patients benefit from innovative medical advancements rooted in global research and development [3]

Core Insights - The Hong Kong pharmaceutical market has shown a structural trend since 2025, with the innovative drug sector becoming a focal point for investment due to its transition to profitability and international expansion [1][2] Industry Overview - In the first half of 2025, 149 Hong Kong-listed pharmaceutical companies reported a 29.7% year-on-year increase in net profit attributable to shareholders, with 36 innovative drug companies generating revenues of 28.5 billion yuan, marking a 15.8% growth [1] - The innovative drug sector has transitioned from a "research and development phase" to a "commercialization phase," driven by companies like BeiGene and Innovent Biologics, which have validated their commercialization capabilities [2] - The current market sentiment favors "high cost-performance" targets, with a focus on companies that have stable R&D pipelines and mature commercialization systems [2] Investment Opportunities - The innovative drug sector is characterized by "high certainty and high elasticity," with increased market rotation and investment interest in companies with strong performance and growth potential [2][3] - Companies with differentiated innovation capabilities and global commercialization potential are recommended for investment, as they are expected to experience rapid revenue growth and profitability [3] - The market is actively seeking investment targets that combine "valuation recovery and product realization," with a focus on companies like Vison Pharma, which is positioned in the growth hormone market [4][5] Company Spotlight: Vison Pharma - Vison Pharma is recognized as an undervalued innovative drug company with both valuation recovery and growth potential, focusing on the growth hormone market [5][6] - The company's core product, Lonapegsomatropin, is expected to be commercialized in China, with significant market potential and a strong clinical validation track record [6][7] - Vison Pharma has established strategic partnerships to enhance its commercialization capabilities, including exclusive promotion agreements and local production arrangements [7][8] Market Positioning - Vison Pharma's upcoming product launch is crucial for its value realization, with the potential to capture a significant market share in the long-acting growth hormone segment [6][9] - The company is well-positioned in a "value gap" state, avoiding the risks associated with early-stage biotech while not being assigned the high valuations typical of mature pharmaceutical companies [9]