Enkailai Therapeutics Completes Tens of Millions of RMB Series A++ Financing to Advance NK Cell Therapy Pipeline

Nov 23, 2024 06:51 CST Updated 06:51

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Comprehensive Medical Information

1. Notice on 50 Batches of Non-Conforming Cosmetics Released by the National Medical Products Administration

Recently, the National Medical Products Administration (NMPA) announced the detection of 50 batches of non-compliant cosmetics during the 2024 national cosmetic sampling inspection. These were tested by institutions such as the Jiangsu Institute for Food and Drug Control. According to the Regulations on the Supervision and Administration of Cosmetics, the Measures for the Supervision and Administration of Cosmetic Production and Operation, and the Measures for the Administration of Cosmetic Sampling Inspection, the NMPA has requested drug regulatory authorities in Tianjin, Liaoning, Jiangsu, Guangdong, and the Guangxi Zhuang Autonomous Region to investigate the registrants, record-filers, contract manufacturers, and other entities involved with these non-compliant products. Relevant enterprises have been ordered to immediately implement risk control measures and carry out self-inspection and rectification. (NMPA)

2. China's Ministry of Industry and Information Technology actively supports foreign-funded enterprises in establishing R&D centers in China.

Recently, the Ministry of Industry and Information Technology (MIIT) stated at a regular policy briefing of the State Council that it will continue to deepen pragmatic and open cooperation in the fields of industry and information technology. The ministry will leverage multilateral and bilateral government cooperation mechanisms to promote policy coordination, industrial exchange, and collaboration. The MIIT also actively supports foreign-funded enterprises in establishing research and development centers in China and encourages joint technological research and industrialization cooperation with local Chinese companies. It aims to provide higher-quality services and guarantees for scientists, entrepreneurs, and investors from various countries to innovate and start businesses in China. Additionally, the ministry encourages manufacturing companies to expand outbound investment cooperation, actively participate in the formulation of international standards, and promote China's advanced technologies and standards in the global market. (Jiemian News)

3. Guizhou Province Drug Administration "Addition, Subtraction, Multiplication, and Division" to Enhance Services

Recently, the Guizhou Provincial Medical Products Administration has focused on optimizing the business environment, using the government service window as a link, and skillfully applying the "addition, subtraction, multiplication, and division" methods to promote the high-quality development of the pharmaceutical industry. First, strengthen internal capabilities by doing "addition" to accelerate service speed. Second, reduce costs and burdens by doing "subtraction," with five comprehensive services for the public. The window vigorously promotes government service items such as "one-network handling," "province-wide handling," "full-process online handling," and "electronic license application." By optimizing approval processes, reducing approval time, and minimizing application materials, the approval efficiency has become more efficient and convenient. Third, enhance responsibility by doing "multiplication" to provide refined services. Proactive analysis, proactive handling, and proactive service help understand enterprises' production intentions, establish demand records, strengthen internal coordination, and facilitate relevant information transmission and pre-approval guidance services, shortening the time for pharmaceutical companies to start production. Fourth, solve problems by doing "division" to unleash new development momentum. (Guizhou Province)

4. Shenyang Medical Insurance Adds 148 Drugs (Groups) and 10 Types of Medical Consumables for Centralized Bulk Procurement

Recently, the Shenyang Municipal Government Press Office held a press conference on the "Progress of Centralized Bulk Procurement of Medicines and Medical Consumables in Shenyang." Next year, new varieties will be included in the centralized bulk procurement list for medical insurance medicines and consumables. The central government will organize the tenth batch of medicine procurement, while provincial alliances will carry out procurement work for five categories of medical consumables, including Chinese herbal slices, biochemical test reagents related to sugar metabolism, and peripheral vascular interventional microcatheters. The reporting process has already concluded, and the implementation of the selected results will begin next year. It is expected that Shenyang will add 148 (groups) of medicines and 10 categories of medical consumables to the centralized bulk procurement. Moving forward, the Shenyang Municipal Medical Security Bureau will focus on public needs and continue to carry out high-quality, routine, and institutionalized centralized bulk procurement of medicines and medical consumables. (China News Service)

5. The Ministry of Commerce issues a notice to support Suzhou Industrial Park

Recently, the Ministry of Commerce officially released a notice regarding the issuance of the "Several Measures to Support Suzhou Industrial Park in Deepening Comprehensive Pilot Reform for Open Innovation." To support Suzhou Industrial Park in deepening comprehensive pilot reform for open innovation, the following measures were proposed: Encourage Jiangsu Province and Suzhou City to further optimize the policy environment conducive to the innovative development of medical equipment in Suzhou Industrial Park. Take the lead in piloting initiatives such as promoting medical institutions’ support for procurement and application of innovative medical devices, as well as their iterative upgrades. Build strategic emerging industry clusters represented by biomedicine. Strengthen and expand the core area of China's national strategic emerging industrial cluster for biomedicine in Suzhou, the national advanced manufacturing cluster for biomedicine and high-end medical devices, the national innovative cluster for bio-pharmaceuticals production, the national advanced manufacturing cluster for nanomaterials, and the national innovative cluster. Support Suzhou Industrial Park in carrying out pilot projects for open innovation across the entire biomedicine industry chain. (Medical Device Innovation Network)

6. TMINI Surgical Robot Receives FDA 510(k) Clearance

Recently, Think Surgical, a surgical robot company, announced that its TMINI surgical robot has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use with LinkSymphoKnee. This clearance enables Think Surgical to enter into a collaboration agreement with Waldemar Link GmbH & Co. KG and continue advancing. The clearance adds Waldemar Link's LinkSymphoKnee to Think Surgical’s ID-Hub, a proprietary implant module database compatible with the open-platform version of the TMINI system. TMINI received FDA clearance in May 2023. It is equipped with a wireless robotic handpiece that assists surgeons in total knee replacement procedures. (Medical Device News)

7. What is the medical device public service platform?

The Medical Device Public Service Platform is jointly developed by the Aosunda Group with local governments, parks, medical institutions, and research universities. It focuses on incubating, transforming, and investing in cutting-edge and innovative global medical device technology projects. By establishing a scientific research and transfer mechanism aligned with international standards and implementing an open and shared operation model, it attracts top-level scientific researchers, doctors, and innovators from around the world. The platform provides comprehensive industry technical services that integrate R&D transformation, incubation, and investment, nurturing innovative medical device achievements with significant innovation and application value. This effort strongly supports the development of the medical device industry and technological innovation. (Organized by Aosunda)

8. Enka Saiyao Completes Tens of Millions of Yuan in A++ Round Financing

Recently, Enka Therapeutics (Shanghai Enka Cell Technology Co., Ltd.) announced the completion of a multi-million yuan A++ round of financing. This round was led by 3SBio, with follow-up investments from Zhangjiang Science & Innovation and Yijin Capital, among others. The funds raised will be used to accelerate the research, development, and clinical trial progress of Enka Therapeutics' product pipeline. Enka Therapeutics was founded by a core technical team led by Tian Zhigang, an academician of the Chinese Academy of Engineering and the European Academy of Sciences. The company focuses on innovative cell drug technology R&D and production based on NK cells, aiming to provide patients with more effective and safer precision immunotherapy options. In March 2020, with strong support from the Shanghai municipal government, Zhangjiang Management Committee, and Zhangjiang Group, Enka Therapeutics settled in the Zhangjiang Cell Industrial Park. In 2024, two of Enka Therapeutics’ NK cell products obtained clinical trial (IND) approvals from the U.S. FDA and China's CDE respectively. (VcBeat)