创新药研发
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百诚医药:创新药BIOS-0623-Z4片获得临床试验批准
Zhi Tong Cai Jing· 2025-09-29 09:25
BIOS-0623-Z4片是由公司自主研发的一种非阿片类靶点机制应用于成人癌痛治疗的药物,目前无同靶 点且同适应症药品上市。BIOS-0623-Z4片属于"境内外均未上市的创新药",其注册分类为化学药品1 类。 百诚医药(301096)(301096.SZ)发布公告,公司近日获悉,公司自主研发的创新药BIOS-0623-Z4片获 得国家药品监督管理局(NMPA)临床试验批准通知书。 ...
德展健康:公司有多个处于不同研发阶段的自研创新药项目
Zheng Quan Ri Bao Wang· 2025-09-29 09:16
Core Viewpoint - The company, Dezhan Health (000813), is actively engaged in multiple self-developed innovative drug projects at various stages of research and development, while also exploring collaboration opportunities [1] Group 1 - The company emphasizes strengthening its independent research and development efforts [1] - The company is open to exploring cooperative opportunities in the pharmaceutical sector [1] - The company commits to adhering to information disclosure rules for any matters that require disclosure [1]
百诚医药(301096.SZ):创新药BIOS-0623-Z4片获得临床试验批准
智通财经网· 2025-09-29 09:16
Core Viewpoint - 百诚医药's innovative drug BIOS-0623-Z4 has received clinical trial approval from the National Medical Products Administration (NMPA) in China, marking a significant milestone for the company in the oncology pain management sector [1] Company Summary - 百诚医药 has developed BIOS-0623-Z4, a non-opioid drug targeting adult cancer pain treatment, which currently has no other drugs with the same target and indication available in the market [1] - The drug is classified as a Class 1 chemical drug and is categorized as an innovative drug that has not been marketed domestically or internationally [1]
科兴制药(688136.SH):GB10注射液临床试验注册申请获得受
Ge Long Hui A P P· 2025-09-29 09:11
Core Viewpoint - Company received acceptance notice for clinical trial application of GB10 injection from the National Medical Products Administration, marking a significant step in the development of innovative drugs [1] Group 1: Product Development - GB10 injection is a high-concentration ophthalmic injection targeting both VEGF and Ang-2, developed by the company's wholly-owned subsidiary, Shenzhen Kexing [1] - Preclinical data indicates that GB10 injection's biological activity and animal efficacy meet international competitive standards, effectively inhibiting choroidal neovascularization in laser-induced monkey models [1] Group 2: Strategic Importance - Acceptance of the clinical trial application represents a key advancement in the company's dual-antibody research and development strategy based on its proprietary technology platform [1] - Successful future commercialization of GB10 injection could diversify the product offerings and enhance the company's market competitiveness [1]
百诚医药:创新药BIOS-0623-Z4片获得临床试验批准通知书
Xin Lang Cai Jing· 2025-09-29 08:34
百诚医药公告,近日获悉,公司自主研发的创新药BIOS-0623-Z4片获得国家药品监督管理局(NMPA) 临床试验批准通知书。BIOS-0623-Z4片是由公司自主研发的一种非阿片类靶点机制应用于成人癌痛治 疗的药物,目前无同靶点且同适应症药品上市。药品名称:BIOS-0623-Z4片,注册分类:1类,适应 症:缓解成人癌痛,申请人:杭州百诚医药科技股份有限公司,受理号:CXHL2500675、 CXHL2500676,目前所处审批阶段:IND批准(临床试验获批),审批结论:根据《中华人民共和国药 品管理法》及有关规定,经审查,2025年7月10日受理的BIOS-0623-Z4片临床试验申请符合药品注册的 有关要求,同意本品开展缓解成人癌痛的临床试验。 ...
长春高新冲刺港交所 连续8年跻身“中国医药工业百强企业榜单”
Zhi Tong Cai Jing· 2025-09-29 06:56
Core Viewpoint - Changchun High-tech has submitted a listing application to the Hong Kong Stock Exchange, aiming to expand its market presence after being listed on the Shenzhen Stock Exchange. The company is recognized as a leading innovation-driven pharmaceutical group in China, with a comprehensive product portfolio across various drug categories [1]. Group 1: Company Overview - Changchun High-tech is a prominent pharmaceutical group in China, focusing on therapeutic biological agents, chemical drugs, vaccines, and traditional Chinese medicine, with capabilities in R&D, production, and commercialization across all major drug registration types [1]. - The company has established a competitive and diversified product matrix driven by a differentiated innovation strategy, leading to strong financial performance and sustainable growth [1]. Group 2: Product Development and Pipeline - As of September 23, 2025, Changchun High-tech has successfully launched 13 new drug products, including the first domestically developed shingles vaccine approved in January 2023 and the first innovative biological drug for acute gouty arthritis approved in June 2025 [2]. - The company is actively expanding the indications of its approved products to cover a broader patient population, such as the approval of Jin Sai Zeng for ISS and Turner syndrome in 2024, which addresses approximately 82.3% of the pediatric short stature population in China [2]. Group 3: Financial Performance - The company reported revenues of approximately RMB 126.27 billion, RMB 145.66 billion, RMB 134.66 billion, and RMB 66.03 billion for the fiscal years 2022, 2023, 2024, and the six months ending June 30, 2025, respectively. Corresponding profits for these periods were approximately RMB 42.15 billion, RMB 47.76 billion, RMB 27.08 billion, and RMB 9.32 billion [3].
新股消息 | 长春高新冲刺港交所 连续8年跻身“中国医药工业百强企业榜单”
Zhi Tong Cai Jing· 2025-09-29 06:51
Core Viewpoint - Changchun High-tech Industry (Group) Co., Ltd. has submitted a listing application to the Hong Kong Stock Exchange, with CITIC Construction Investment International as the sole sponsor, indicating its intention to expand its market presence after being listed on the Shenzhen Stock Exchange [1][3]. Group 1: Company Overview - Changchun High-tech is a leading innovation-driven pharmaceutical group in China, covering therapeutic biological agents, chemical drugs, vaccines, and traditional Chinese medicine, with comprehensive capabilities in R&D, production, and commercialization across all major drug registration types [3][4]. - The company has established a strong and diversified product portfolio in various therapeutic areas, including endocrine and metabolic diseases, women's health, immune and respiratory diseases, tumors, vaccines, and traditional Chinese medicine [4]. Group 2: Financial Performance - The sales revenue of Changchun High-tech's pharmaceutical products reached RMB 12.7 billion in 2024, maintaining over RMB 10 billion for four consecutive years [3]. - The company has consistently ranked among the "Top 100 Pharmaceutical Enterprises in China" for eight consecutive years since 2017 [3]. - Revenue figures for the fiscal years 2022 to 2025 show a growth trajectory, with revenues of approximately RMB 126.27 billion, RMB 145.66 billion, RMB 134.66 billion, and RMB 66.03 billion for the first half of 2025 [5][7]. Group 3: Product Development and Pipeline - As of September 23, 2025, Changchun High-tech has over 40 candidate drugs in clinical stages or submitted for IND applications, including 14 in Phase III clinical trials or NDA stages and 15 first-class innovative drugs [5]. - The company has successfully launched 13 new drug products during the historical record period, including the first domestically developed shingles vaccine approved in January 2023 and the first innovative biological drug for acute gouty arthritis approved in June 2025 [4][5].
新股消息 | 长春高新(000661.SZ)冲刺港交所 连续8年跻身“中国医药工业百强企业榜单”
智通财经网· 2025-09-29 06:50
Core Viewpoint - Changchun High-tech Industry (Group) Co., Ltd. has submitted a listing application to the Hong Kong Stock Exchange, with CITIC Construction Investment International as the sole sponsor, while already being listed on the Shenzhen Stock Exchange [1]. Group 1: Company Overview - Changchun High-tech is a leading innovation-driven pharmaceutical group in China, covering therapeutic biological agents, chemical drugs, vaccines, and traditional Chinese medicine, with capabilities across all major drug registration types in China [4]. - The company has established a competitive and diversified product matrix through a differentiated innovation strategy, leading to strong financial performance and a solid foundation for sustainable growth [4]. - In 2024, the sales revenue from pharmaceutical products is projected to reach RMB 12.7 billion, maintaining over RMB 10 billion for four consecutive years [4]. Group 2: Product Development and Pipeline - Changchun High-tech has developed a strong and diversified product portfolio in areas such as endocrine and metabolic diseases, women's health, immune and respiratory diseases, tumors, vaccines, and traditional Chinese medicine [5]. - The company has successfully launched 13 new drug products, including the first domestically developed shingles vaccine approved in January 2023 and the first innovative biological drug for acute gouty arthritis approved in June 2025 [5]. - As of September 23, 2025, the company has over 40 candidate drugs in clinical stages or submitted for IND applications, including 14 in Phase III clinical trials or NDA stages, showcasing potential for global first-in-class or best-in-class drugs [6]. Group 3: Financial Performance - For the fiscal years 2022 to 2025, the company reported revenues of approximately RMB 12.63 billion, RMB 14.57 billion, RMB 13.47 billion, and RMB 6.64 billion for the first half of 2025, respectively [6][8]. - The net profit for the same periods was approximately RMB 4.22 billion, RMB 4.78 billion, RMB 2.71 billion, and RMB 0.93 billion for the first half of 2025, indicating fluctuations in profitability [6][8].
“减肥药概念股”博瑞医药拟港股上市,恒生医疗ETF(513060)午后翻红
Xin Lang Cai Jing· 2025-09-29 05:25
Group 1 - The Hang Seng Healthcare Index rose by 1.22%, with notable increases in stocks such as InnoCare Pharma-B (up 7.03%) and Alibaba Health (up 4.51%) [2] - The Hang Seng Healthcare ETF (513060) saw a 4.55% increase over the past month, ranking in the top third among comparable funds [2] - The trading volume for the Hang Seng Healthcare ETF was active, with a turnover of 10.9% and a transaction value of 784 million yuan [2] Group 2 - The Hang Seng Hong Kong Stock Connect Innovative Drug Selection Index increased by 0.95%, with InnoCare Pharma-B leading the gains [3] - The Hong Kong Stock Innovative Drug Selection ETF (520690) experienced a slight decline of 0.20%, but had a 2.99% increase over the past month, ranking in the top half among comparable funds [3][5] - The trading volume for the Hong Kong Stock Innovative Drug Selection ETF was also active, with a turnover of 16.1% and a transaction value of 68.27 million yuan [5] Group 3 - The CSI Pharmaceutical 50 Index fell by 0.89%, with mixed performance among constituent stocks [6] - The Pharmaceutical 50 ETF (159838) decreased by 0.62%, but had a 2.37% increase over the past month [6] - The trading volume for the Pharmaceutical 50 ETF was lower, with a turnover of 1.45% and a transaction value of 2.39 million yuan [6] Group 4 - Rongchang Bio's "Taitasip" is set for priority review for treating IgA nephropathy, showing potential in reducing proteinuria [7] - CanSino announced an A-share restricted stock incentive plan and H-share stock option plan, aiming to motivate its core team with performance targets [7] - Borui Pharma plans to issue H-shares and list on the Hong Kong main board, reflecting an accelerated trend of A+H listings [7] Group 5 - The recent dynamics in the pharmaceutical sector highlight a focus on innovative drugs and capital operations, with Rongchang Bio's progress potentially boosting sector sentiment [8] - CanSino's incentive plan is expected to stabilize investor expectations by aligning core team interests with long-term performance [8] - Borui Pharma's cross-market strategy demonstrates the use of dual platforms to optimize capital structure, likely attracting investor attention [8] Group 6 - The Hang Seng Healthcare ETF has a latest scale of 7.148 billion yuan, ranking in the top third among comparable funds [12] - The Hong Kong Stock Innovative Drug Selection ETF reached a new high with a scale of 422 million yuan [13] - The Pharmaceutical 50 ETF tracks the top 50 pharmaceutical companies in A-shares, with the top ten stocks accounting for 58.68% of the index [14]
天风证券:维持绿叶制药(02186)“买入”评级 在研管线具备差异化优势
智通财经网· 2025-09-29 04:06
Core Viewpoint - Tianfeng Securities has revised down the revenue and net profit forecasts for Green Leaf Pharmaceutical for 2025 to 2026 due to intense market competition and centralized procurement impacts, while maintaining a "Buy" rating [1] Group 1: Financial Performance - The revenue forecast for Green Leaf Pharmaceutical has been adjusted from 85.29 billion and 102.79 billion to 66.38 billion and 74.47 billion for 2025 and 2026 respectively, with an expected revenue of 81.62 billion for 2027 [1] - The net profit forecast has been revised down from 13.73 billion and 16.78 billion to 6.72 billion and 8.31 billion for 2025 and 2026 respectively, with an expected net profit of 9.16 billion for 2027 [1] - In the first half of 2025, the company reported revenue of 31.81 billion, a year-on-year increase of 3.5%, while the net profit attributable to the parent company was 3.13 billion, a year-on-year decrease of 19.3% [1] Group 2: Business Focus and Product Development - The company is focusing on two major areas: CNS (Central Nervous System) and oncology, with multiple new products beginning commercialization and an increasing sales proportion of new products (up 32% year-on-year) [1] - In the oncology treatment sector, revenue reached 12.95 billion, a year-on-year increase of 13.5%, while CNS treatment revenue was 8.68 billion, up 5.4%. Cardiovascular treatment revenue was 6.93 billion, down 9.2%, and metabolic treatment revenue was 1.80 billion, down 7.9% [1] Group 3: New Product Commercialization - The company has successfully commercialized two major products in the CNS field, with Ruxinlin being the first domestically developed antidepressant included in the 2024 medical insurance directory, showing over 4 times year-on-year sales growth [2] - ERZOFRI, a product for treating schizophrenia, entered the U.S. market in April 2025, being the first of its kind developed by a Chinese company with independent intellectual property rights [2] - ERZOFRI has a long patent period until 2039 and is currently in a favorable competitive landscape with only two companies in the market [2] Group 4: Innovation Pipeline - The company has a rich pipeline of innovative drugs in development, actively seeking business development collaborations with multinational corporations [3] - LY03017, aimed at treating Parkinson's disease psychosis and Alzheimer's disease psychosis, is expected to complete Phase I clinical trials in China by the end of 2025, with IND approval anticipated in Q3 2025 [3] - Other innovative drugs, including LY03015 for tardive dyskinesia and Huntington's disease, are in Phase II clinical trials, with data expected in the first half of 2026 [3]