China National Pharmaceutical Group establishes new medical company; Heng Rui Medical's AI fully automatic injection pen production line begins mass production | Domestic Medical Device Weekly Report
01
Regulatory Dynamics
The National Medical Device Sampling Inspection Work Promotion Meeting for 2025 was held.
On March 26, the official website of the National Medical Products Administration announced that a meeting to promote the national medical device sampling inspection work was held in Chengdu. The meeting summarized the achievements of the sampling inspection work in 2024, conducted an in-depth analysis of the current situation, and researched and deployed the key tasks for sampling inspection in 2025.
The meeting noted that at all levels, the drug regulatory authorities and medical device inspection institutions have earnestly implemented the "four strictest" requirements, closely following the work思路of "upholding political integrity, strengthening regulation, ensuring safety, promoting development, and benefiting people's livelihoods." They successfully completed the 2024 national supervision and sampling tasks, which have promoted improvements in product quality and effectively safeguarded the public's safe use of medical devices.
2. Disposable pressure-sensing radiofrequency ablation catheter innovative product approved for NMPA market launch
On March 26, the National Medical Products Administration approved the registration application for the innovative product of Hunan Aipute Medical Device Co., Ltd.'s disposable pressure monitoring radiofrequency ablation catheter.
The single-use pressure monitoring radiofrequency ablation catheter enables real-time pressure monitoring and feedback during clinical use through a built-in optical pressure sensor, ensuring the stability of the ablation effect. This product can effectively reduce the risks of steam pop caused by excessive contact between the catheter and tissue during the procedure or incomplete ablation due to insufficient contact, benefiting more patients with paroxysmal atrial fibrillation.
3. Broncus Medical: Lung Imaging Processing Software Approved for Market Launch in China
On March 21, Broncus Medical announced that its lung imaging processing software, BroncQCT, has been officially approved by the Zhejiang Provincial Medical Products Administration for launch in China.
The approval of this software for marketing reflects Broncus Medical's commitment to developing solutions that enhance clinical benefits, further solidifying the company's position in the field of precise interventional diagnosis and treatment of pulmonary diseases. It is expected that this software will improve doctors' efficiency in reading pulmonary CT images, provide strong support for clinical auxiliary diagnosis and treatment, and promote a more efficient and accurate diagnostic process.
02
Capital Market
Wanhai Medical Completes 100 Million Yuan Financing
Recently, Jiangsu Wanhai Medical Devices Co., Ltd. announced the completion of financing amounting to one billion yuan, with this round exclusively invested by IDG Capital.
This financing will help Wanhai Medical further expand its annual production capacity from the existing 90 million units to 310 million units, forming a total production capacity of 400 million units at an automated and intelligent injection pen production base, further consolidating its leadership position in the global injection pen market.
Wanhai Medical, founded in 2016, is headquartered in Xitaihu, Changzhou, Jiangsu, with a branch in Shanghai. It is a national high-tech enterprise and a specialized and innovative company. The company focuses on the research, development, production, and sales of various injection pen products.
Cheng Tian Technology Completes Series B Financing of Nearly 100 Million Yuan
This week, Hangzhou Chengtian Technology Development Co., Ltd. announced the completion of nearly 100 million yuan in Series B financing. This round of financing was led by Xichuang Investment. The funds will be primarily used for the research and development iteration of embodied intelligent exoskeleton technology, the development and registration of new brain-machine products, the expansion of production bases, and global market expansion, further promoting the application of embodied intelligent exoskeleton wearable robots in rehabilitation, elderly care, and consumer markets, accelerating the expansion of domestic and international channel networks, and building a globally leading exoskeleton technology enterprise.
3. Sanxin Medical's net profit increased by 10.05% year-on-year in 2024.
On March 26, Sanxin Medical disclosed its annual report, showing that the company achieved operating revenue of 1.5 billion yuan in 2024, increasing by 15.41% year-on-year; net profit was 227 million yuan, increasing by 10.05% year-on-year; basic earnings per share was 0.44 yuan. The company plans to distribute a cash dividend of 2 yuan per 10 shares (including tax). During the reporting period, the blood purification products achieved operating revenue of 1.217 billion yuan, increasing by 28.20% over the same period last year. The operating revenue of such products accounted for 81.11% of the company's total revenue.
Wandong Medical's operating revenue increased by 23.26% year-on-year in 2024.
On March 21, Wandong Medical disclosed its 2024 financial report, showing that the company achieved operating revenue of 1.524 billion yuan during the reporting period, a year-on-year increase of 23.26%; the non-GAAP net profit attributable to the parent company was 142 million yuan, a year-on-year increase of 4.84%.
Amplex Corporation's net profit for the year 2024 is 1.958 billion yuan. (Note: The company name "爱美客" is translated as "Amplex Corporation" assuming it refers to a fictional or general cosmetic company based on the context. If this is a specific company, please provide the correct English name for an accurate translation.)
On the evening of March 19, Aimeike announced its annual report for 2024. In 2024, the company achieved operating revenue of 3.026 billion yuan, a year-on-year increase of 5.45%; the net profit attributable to shareholders of the listed company was 1.958 billion yuan, a year-on-year increase of 5.33%; the net profit attributable to shareholders of the listed company after deducting non-recurring gains and losses was 1.872 billion yuan, a year-on-year increase of 2.2%.
6. Innovation Medical's major shareholders, directors, and executives all announced share reduction plans.
On March 24, Innovative Medical issued a share reduction announcement, stating that the company recently received the "Notice of Share Reduction Plan." Shareholders Shanghai Guanghuan, Director Ruan Guangyin, and Acting CFO Ma Jianjian respectively submitted their reduction plans.
Holding 3,160,200 shares of the company, accounting for 0.7161% of the company's total share capital, plans to reduce the company's shares by centralized bidding within three months after 15 trading days from the date of this announcement. The reduction quantity will not exceed 790,000 shares, which is no more than 0.1791% of the company's total share capital.
03
Corporate News
On March 24, information on the AiQicha website showed that Huiyikang Medical Health Technology (Shanghai) Co., Ltd. was established, with Chen Tao as the legal representative. The company has a registered capital of 20 million RMB and is wholly owned by Yukang Hongbo Medical (Xiamen) Co., Ltd.
The business scope includes: health consulting services (excluding medical treatment services); remote health management services; medical research and experimental development; sales and leasing of Class I medical devices; sales of household appliances; sales of personal hygiene products; sales of hygiene products and disposable medical supplies; sales and leasing of Class II medical devices, etc. The investor, Yuhong Hongbo Medical, is a subsidiary of China National Pharmaceutical Group Corporation.
2. Hengrui Medical AI Full-Automatic Injection Pen Production Line Mass Production
This week, Suzhou Precision Medical Technology Co., Ltd., a subsidiary of Suzhou Hengrui Medical Devices Co., Ltd., announced the official commencement of mass production on its first AI fully automated injection pen production line, with an annual capacity of 20 million units. Additionally, the company has established strategic partnerships with several industry leaders, including Zhitai Biotech, WuXi Biologics, and Porton Biologics.
This milestone event marks that while breaking through patent barriers and achieving independent original research, China's domestically produced automatic injection pen has made key progress in the field of intelligent manufacturing of new drug delivery devices.
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