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中国内地生物类似药集采启动在即,或涉及多个大品种
BOCOM International· 2025-08-04 07:09
Investment Rating - The report maintains a "Buy" rating for several companies in the biotechnology sector, including Legend Biotech (LEGN US), and others like 3SBio (1530 HK), Innovent Biologics (1801 HK), and more, indicating a positive outlook for these stocks [7]. Core Insights - The upcoming centralized procurement of biosimilars in mainland China is expected to impact multiple major products, with the first round of information collection already initiated [2]. - The report emphasizes that the impact of this procurement on company performance and product sales will likely be felt starting in 2026, as the process is expected to take longer due to the novelty of biosimilar procurement in China [2]. - Companies such as China Biologic Products, Innovent Biologics, and Hengrui Medicine are highlighted as key players with multiple products involved in the procurement process, warranting close attention to pricing and allocation results [2][3]. - The report suggests that the impact on innovative drugs will be limited, as the products involved in the procurement are off-patent and already have competing biosimilars [2]. Summary by Sections Section: Centralized Procurement - The centralized procurement for biosimilars is officially starting, with a focus on eight monoclonal antibody products [2]. - The information collection phase is expected to last 1-2 months, with a longer timeline anticipated for rule formulation and final product inclusion [2]. Section: Company Focus - Key companies to watch include China Biologic Products, Innovent Biologics, and Hengrui Medicine, with respective products in the procurement process [2]. - The report recommends monitoring the pricing and allocation outcomes closely for these companies [2]. Section: Innovative Drugs - The report indicates that the eight monoclonal antibodies involved in the procurement are already off-patent and have existing biosimilars, suggesting limited impact on innovative drugs still under patent [2]. - Continuous attention is advised for the upcoming national medical insurance negotiations and the establishment of commercial insurance innovative drug directories [2].
7月2日晚间重要公告一览
Xi Niu Cai Jing· 2025-07-02 10:18
Group 1 - CITIC Construction Investment has received approval from the China Securities Regulatory Commission to issue perpetual subordinated bonds with a total face value of no more than 20 billion yuan [1] - Bluefocus Technology has received a loan commitment of up to 900 million yuan from CITIC Bank for stock repurchase [1] - Huaren Pharmaceutical's subsidiary has received approval for the listing of Bumetanide raw materials, which are used to treat severe heart failure and hypertension emergencies [3] Group 2 - Betta Pharmaceuticals has received approval for the listing of Enasidenib capsules in Macau, aimed at treating ALK-positive locally advanced or metastatic non-small cell lung cancer [4] - Juewei Food plans to use 110 million yuan of idle fundraising for cash management, with an expected annual yield of 1.00%-1.89% [6] - China Huadian has successfully completed the issuance of 1 billion yuan medium-term notes with a coupon rate of 1.95% [9] Group 3 - Fosun Pharma's subsidiary has received a GMP certificate from the Belgian Federal Agency for Medicines and Health Products for the production facilities of two monoclonal antibodies [11] - China Nuclear Engineering has signed a civil engineering contract for the Taishan Nuclear Power Units 3 and 4 [13] - Kanglongda has faced administrative regulatory measures from the Zhejiang Securities Regulatory Bureau due to the failure of performance commitment parties to fulfill compensation obligations [15] Group 4 - Gaoling Information has received three invention patent certificates in the second quarter, covering various technological fields [16] - Weimais plans to use 190 million yuan of excess fundraising to increase capital in its subsidiary for building a new energy vehicle powertrain production base [17] - Huazhong Technology has received a project designation notice from a leading eVTOL manufacturer for the development and supply of an intelligent cockpit multimedia display system [19] Group 5 - Madi Technology expects a net profit of 25 million to 27 million yuan for the first half of 2025, marking a turnaround from a loss in the previous year [19] - Dazhong Mining's subsidiary has obtained a mining license for the Zhouyoufang Iron Mine, increasing production capacity to 6.5 million tons per year [20] - Zhongguancun's subsidiary has had its application for the listing of Arolol hydrochloride tablets accepted by the National Medical Products Administration [21] Group 6 - Tianhong Co. has signed a property management contract worth 15 million yuan with a local company [22] - Dong'an Power has secured nine new market designation agreements in the second quarter, with a projected total sales volume of 1.5 million units [24] - Zhujiang Co. has appointed Zhao Kun as the new deputy general manager [25] Group 7 - Jinyi Industrial has won a bid for a project worth 335 million yuan from the China Railway Shanghai Bureau Group [26] - Kangchen Pharmaceutical has received a clinical trial notification for its innovative drug KC1086, aimed at treating advanced solid tumors [27] - Changhua Group has received a project designation notice from a new energy vehicle company, with an expected total sales amount of 970 million yuan [29] Group 8 - Lingxiao Pump Industry plans to use 60 million yuan of idle funds to purchase financial products [31] - Mould Technology has received a project designation for exterior parts from a well-known North American electric vehicle company, with an expected total sales of 1.236 billion yuan [34] - Fulongma has pre-bid for five sanitation service projects in June, with a total contract amount of 181 million yuan [35] Group 9 - Changchun High-tech plans to issue H-shares and list on the Hong Kong Stock Exchange [36] - *ST Yuancheng is under investigation by the CSRC for suspected false financial disclosures [37] - Beilu Pharmaceutical's subsidiary has received approval for the listing of Iopamidol raw materials [38] Group 10 - Zhejiang Liming's shareholder plans to reduce their stake by up to 2.93% [39] - Zhejiang Liming's actual controller has committed not to reduce their holdings within a year [40] - SAIC Motor reported a total vehicle sales of 2.0526 million units in the first half of 2025, a year-on-year increase of 12.35% [41] Group 11 - Xinhongcheng expects a net profit increase of 50%-70% for the first half of 2025 [42] - Xianhe Co. plans to invest 11 billion yuan in a bamboo pulp paper integrated project [42] - Great Wall Motors reported a total vehicle sales of 569,800 units in the first half of 2025, a year-on-year increase of 1.81% [43] Group 12 - Dongfeng Co. received a government subsidy of 10 million yuan [44] - Zhongke Environmental Protection has acquired two water environmental companies in Guangxi for a total of 353 million yuan [45] - Anji Food's H-share public offering is priced at 60 Hong Kong dollars per share [46]
科兴制药引进产品——地舒单抗注射液获中国澳门药监局批准上市
Core Viewpoint - The approval of the two biosimilar drugs, Deshu Single Antibody Injection, by the Macau Drug Regulatory Authority marks a significant milestone for the company, as it is the first major oncology drug from its collaborative products to gain market entry in the Hong Kong and Macau regions [1][2]. Group 1: Product Details - The two approved products are Deshu Single Antibody Injection in 60mg (brand name: Boyoubai) and 120mg (brand name: Boluoga), which are biosimilars of Prolia and Xgeva, respectively [1][2]. - Boyoubai is indicated for osteoporosis in postmenopausal women at high risk of fractures, while Boluoga is used for treating giant cell tumors of bone that cannot be surgically removed or where surgery may lead to severe functional impairment [2]. Group 2: Market Potential - The Chinese market for Deshu Single Antibody is projected to reach 3.741 billion yuan by 2025 and may exceed 10 billion yuan by 2030, driven by an aging population and increasing treatment rates [3]. - In Macau, the population aged 65 and above accounted for 13.66% in 2023, indicating a significant demand for treatments related to osteoporosis and cancer [3]. Group 3: International Strategy - The company has adopted a "global selection, global coverage" strategy, focusing on high-growth emerging markets and the EU, leveraging cost-effective high-end biosimilars [4]. - The establishment of local teams in various countries aims to enhance market responsiveness and competitiveness, facilitating the introduction of products into the European and American markets [4]. - The approval of Deshu Single Antibody in Macau, along with the existing product "Kuyang Capsule" in Hong Kong, enhances the company's market presence in the Guangdong-Hong Kong-Macau Greater Bay Area [4].