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舒瑞基奥仑赛注射液(CT041)
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科济药业:最快明年Q1实体瘤CAR-T有望获批 灵活安排全链条BD交易|直击业绩会
Xin Lang Cai Jing· 2025-08-15 09:44
智通财经8月15日讯(记者 何凡)从业绩上看,H1科济药业-B(02171.HK)净亏损大幅减少,同时舒 瑞基奥仑赛注射液(产品编号:CT041,一种靶向Claudin18.2的自体CAR-T细胞产品)产品提交NDA让 公司在实体瘤领域更进一步,在今日举行的业绩会中,该药物获批时间等备受关注。此外,公司方面还 就通用型CAR-T市场竞争格局,通过商保创新药目录提高产品可及性等问题进行了回应。 对此,科济药业方面表示,整体而言近期国家对于创新产品的支付政策有更积极的探索,针对赛恺泽, 科济药业和华东医药在积极争取,后续的很多细节和价格,有待双方进一步分析和探讨。因为目前很多 政策都尚未明朗,但整体原则来说,公司肯定将积极响应一些大的政策,在平衡商业利益的情况下,希 望尽可能让更多患者获益。 若被纳入商保,公司产品是否会降价也是投资者较为关心的问题,"实际上政策也在不断探索前行。"李 宗海补充说明,最近合作伙伴参加了一些讨论,从保险机构角度来说,他们更多关注投保率的问题。所 以这不仅是简单的价格问题,还是综合多维度的,作为一针给药的CAR-T产品,从药物经济学的角度来 说是能站得住脚的。 在对外BD方面,公司高层 ...
股价新高!创新药“牛股”带队,多家上市公司官宣“优先审评”
Sou Hu Cai Jing· 2025-06-06 08:58
Core Viewpoint - Shuyou Shen's subsidiary, Beijitai, has received priority review status from the National Medical Products Administration (NMPA) for its product STSP-0601, which is intended for the treatment of bleeding in adult patients with hemophilia A or B with inhibitors, marking a significant advancement in the drug's approval process [2][3]. Company Developments - Shuyou Shen's stock price surged nearly 190% over a 10-day period, reaching a peak of 34.49 yuan per share, the highest since 2016, following the announcement of the priority review [4]. - The company has 13 major R&D projects in clinical research stages, focusing on unmet therapeutic needs, including monoclonal antibodies and protein drugs [4]. - The capitalized R&D expenditure for STSP-0601 (with inhibitors) is reported at 85.16 million yuan, while for STSP-0601 (without inhibitors) it stands at 10.89 million yuan [3]. Industry Context - The NMPA has also granted priority review status to other companies, including He Yu and Ke Ji Pharmaceuticals, indicating a broader trend in the industry towards expedited drug approvals [5][6]. - He Yu's drug ABSK021 has received multiple recognitions, including breakthrough therapy designation from the NMPA and FDA, and has seen a significant revenue increase due to licensing agreements [6][7]. - Ke Ji's product, a CAR-T cell therapy candidate, has also been recognized by the NMPA and FDA, highlighting the growing focus on innovative cancer treatments within the industry [7].
医药行业周报:创新药及其产业链大热,后续如何布局?
Tebon Securities· 2025-03-03 03:23
Investment Rating - The report maintains an "Outperform" rating for the pharmaceutical and biotechnology sector [2]. Core Views - The report highlights that the Chinese innovative drug sector is expected to experience new growth logic due to internal and external policy catalysts, suggesting a focus on undervalued small-cap pharmaceutical stocks [5][6]. Summary by Sections 1. Innovative Drugs and Industry Chain - **Sangfor Pharmaceutical**: Core products show steady growth, with innovative pipelines gradually yielding results. The PD-1/VEGF dual antibody AK112 has become the first to defeat K drug in head-to-head Phase III trials, enhancing the development heat for PD(L)-1/VEGF dual antibodies [10][11]. - **Kojin Pharmaceutical**: The CAR-T therapy shows significant potential, with its first product, CT053, approved for multiple myeloma treatment. Another product, CT041, is expected to submit NDA in mid-2025 [12][13]. - **Hotgen Biotech**: The SGC001 drug for acute myocardial infarction is progressing through clinical trials, with promising preclinical data indicating significant therapeutic effects [20][21]. - **Kangfang Biotech**: The company is advancing its IO+ADC strategy, with two dual antibodies already approved. It is collaborating with Pfizer to explore combination therapies for various solid tumors [30][34]. - **Kolin Biotech**: The company is expanding its international clinical trials with Merck, focusing on multiple cancer types [36][40]. 2. Market Performance Review - The pharmaceutical sector index fell by 2.7% from February 24 to February 28, 2025, underperforming the CSI 300 index by 0.5%. However, year-to-date, the sector has risen by 1.1%, outperforming the CSI 300 by 2.3% [43][44]. 3. Investment Strategy and Focus - The report suggests focusing on four main investment lines: 1) Oversold blue-chip stocks and Hong Kong stocks, 2) Companies with positive short-term changes and low price-to-book ratios, 3) Firms with solid fundamentals, and 4) Companies expected to show high growth in H2 2024 [7][8]. - Recommended stocks include Kangfang Biotech, Zai Lab, Kolin Biotech, and others [7]. 4. Industry Outlook - The report anticipates a recovery in the demand for innovative drugs, driven by supportive government policies and increased investment in the biotech sector. This recovery is expected to benefit upstream companies and CRO services [42].