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一周3款小分子创新药获批!“不是癌症的癌症”治疗药物实现中美同步;人用破伤风抗毒素龙头江西生物二次冲击港交所 | 掘金创新药
Mei Ri Jing Ji Xin Wen· 2025-10-28 14:33
Core Insights - The pharmaceutical and biotechnology sector is experiencing a mixed performance, with the medical biotechnology index underperforming the Shanghai Composite Index for five consecutive weeks [4] - Jiangxi Biological Products Research Institute has submitted a new application for listing on the Hong Kong Stock Exchange, heavily reliant on a single product, human tetanus antitoxin (TAT), which constitutes over 93% of its revenue [5][7] - Recent approvals of innovative drugs include a treatment for idiopathic pulmonary fibrosis (IPF) and a new oral hypoglycemic agent, indicating ongoing advancements in the pharmaceutical industry [12][13] Industry Performance - The medical biotechnology index rose by 0.35% from October 20 to October 24, lagging behind the Shanghai Composite Index by 0.36 percentage points [4] - The Hong Kong healthcare index fell by 0.77%, continuing a downward trend despite some positive developments in the sector [4] Company Developments - Jiangxi Biological, the largest provider of human TAT in China, reported revenues of 221 million yuan for 2024 and 99.7 million yuan for the first half of 2025, with a significant reliance on a low-priced product [5][7] - The company has a market share of 36.6% globally and 65.8% domestically for human TAT, but faces risks due to its dependence on a single product [7] Clinical Trials and Approvals - A total of 95 clinical trial registrations were disclosed by the National Medical Products Administration, with 30 trials in Phase II or higher, primarily in oncology and cardiovascular fields [8] - Three small molecule innovative drugs were approved recently, including a PDE4B inhibitor for IPF and a new combination oral hypoglycemic agent for type 2 diabetes [12][13] Market Trends - The recent decline in shares of Huahao Zhongtian Pharmaceutical-B, which has dropped over 33% in two weeks, reflects broader market challenges for innovative drug companies [15][16] - The company has not yet achieved profitability, with a reported revenue of 14.78 million yuan in the first half of the year, down 55.36% year-on-year [15]
一周3款小分子创新药获批!“不是癌症的癌症”治疗药物实现中美同步;人用破伤风抗毒素龙头江西生物二次冲击港交所|掘金创新药
Mei Ri Jing Ji Xin Wen· 2025-10-28 14:33
Market Performance - The pharmaceutical and biotechnology index rose by 0.35% from October 20 to October 24, underperforming the Shanghai Composite Index by 0.36 percentage points, marking five consecutive weeks of underperformance [1] - The innovative drug index (BK1106) saw a slight increase of 0.03%, ending a four-week decline [1] - The Hang Seng Healthcare Index fell by 0.77%, although the decline was less severe than the previous week, indicating a continued downward trend [1] - The Hong Kong innovative drug ETF (513120) decreased by 2.82%, failing to capitalize on positive news from the ESMO conference and significant business development transactions by Innovent Biologics [1] IPO Developments - Jiangxi Biological Products Research Institute Co., Ltd. has submitted a new application for listing on the Hong Kong Stock Exchange, following a failed attempt in April 2023 [2] - Jiangxi Biological is the largest provider and exporter of human tetanus antitoxin (TAT) in China, holding a global market share of 36.6% and a domestic market share of 65.8% in 2024 [2] - The company's revenue is relatively low, projected at 221 million yuan in 2024 and 99.7 million yuan in the first half of 2025, primarily due to the low price of TAT, which averages 3.6 yuan per unit for exports, about 30% of the domestic price [2] Clinical Trials - From October 20 to October 26, the National Medical Products Administration disclosed 95 new clinical trial registrations, with 30 of these being innovative drugs in Phase II or higher, mainly in oncology, cardiovascular, and dermatology fields [6] Drug Approvals - Three small molecule innovative drugs were approved last week, including a PDE4B inhibitor for idiopathic pulmonary fibrosis (IPF), marking the first successful approval for IPF treatment in nearly a decade [9] - The drug, developed by Boehringer Ingelheim, achieved its primary endpoint in Phase III trials and was approved in both the U.S. and China within two weeks [9] - Other approved drugs include a first-line treatment for advanced non-small cell lung cancer (NSCLC) and a new oral hypoglycemic agent for type 2 diabetes [10][11] Company Performance - Huahao Zhongtian Pharmaceutical-B has seen a cumulative decline of over 33% in the past two weeks, attributed to low trading volumes and a general downturn in the innovative drug sector [12] - The company reported a revenue of 14.78 million yuan in the first half of the year, a decrease of 55.36% year-on-year, with a net loss of 54.04 million yuan, slightly improved from the previous year's loss [12]
亚磷酰胺单体将在小核酸产业链中占据重要位置
CAITONG SECURITIES· 2025-10-28 07:57
Core Insights - The report emphasizes the significant role of phosphoramidite monomers in the small nucleic acid industry chain, highlighting their impact on the development of small nucleic acid drugs, which are considered promising candidates for treating various diseases due to their unique molecular structures and therapeutic mechanisms [1][6][10] - The report predicts robust growth in the demand for phosphoramidite monomers, with multinational pharmaceutical companies likely to benefit from this trend, as the global nucleotide market is projected to reach USD 730 million in 2023, with China being the largest production market [10][11] Section Summaries Phosphoramidite Monomer's Role - Phosphoramidite monomers are crucial raw materials for synthesizing small nucleic acid drugs, enhancing their stability and biological activity, and driving innovation in drug development [6][9] - The solid-phase phosphoramidite method is the mainstream technique for synthesizing oligonucleotides, which are a major cost component in nucleic acid drug production [9] Market Dynamics - The report notes that 90% of global nucleotides are used for nucleic acid drug production, with only about 10% allocated to health foods and agriculture [10] - The small nucleic acid drug market is primarily dependent on major multinational pharmaceutical companies, indicating potential benefits for companies within their supply chains [11] Investment Recommendations - The report suggests focusing on innovative drug companies such as Furuya Co., OncoOne, and others, as well as raw material suppliers like WuXi AppTec and others, indicating a diverse range of investment opportunities in the sector [10]