According to recent foreign media reports, Science Corporation announced that its oversubscribed $230 million Series C funding round has ended. According to Science Corporation, participants in this funding round include Lightspeed Venture Partners, Khosla Ventures, Y Combinator, IQT, and Quiet Capital. The funds will be used to accelerate the commercialization of its brain-computer interface technology. To date, the company has raised approximately $490 million in total funding . Science Corporation, founded in 2021 and headquartered in Alameda, California, is led by Neuralink co-founder Max Hordak and is currently advancing clinical trials of the Prima retinal implant . It’s worth mentioning that Science possesses the Prima retinal implantation technology developed by Pixium Vision. The Prima system, a photovoltaic alternative to photoreceptor cells, has received Breakthrough Device designation from the U.S. Food and Drug Administration , allowing for the simultaneous use of central prosthetic vision and peripheral natural vision. Furthermore, Prima technology ...
Drugdu.com expert’s response: Whether supporting instruments require prior certification when in vitro diagnostic (IVD) reagents undergo clinical trials necessitates a case-by-case analysis, as detailed below: I. Supporting Instruments Already Marketed and Certified If the supporting instrument is a product already on the market and has obtained relevant certifications (e.g., medical device registration certificate), it can be directly used in clinical trials. In this case, the following must be ensured: Complete Instrument Qualifications: Provide the instrument’s production license, quality management system certificate, product inspection report, and other documents to demonstrate compliance with regulatory requirements. Sufficient Performance Verification: Clearly specify the model, specifications, and compatibility with the reagent of the supporting instrument in the clinical trial protocol, and verify its detection performance (e.g., accuracy, precision) through pre-trials. Comprehensive Usage Records: Document the receipt, storage, distribution, usage, and maintenance of the instrument to ensure traceability throughout the trial process. II. Supporting Instruments as ...
March 4th – AnglikangThe company announced that it recently obtained adenosine cobalt from the National Medical Products Administration.The company has obtained the Drug Registration Certificate for Amino Capsules. This drug is indicated for the adjunctive treatment of megaloblastic anemia, nutritional anemia, anemia of pregnancy, polyneuritis, radiculitis, trigeminal neuralgia, sciatica, nerve palsy, as well as nutritional disorders and radiation- and drug-induced leukopenia. The company received the notification of acceptance for its marketing authorization application in June 2024 and recently received approval from the National Medical Products Administration. The announcement indicates that, according to relevant national policies, obtaining the Drug Registration Certificate is considered equivalent to passing the consistency evaluation. This drug registration certificate will further enrich the company’s product pipeline; however, drug sales are easily affected by factors such as national policies and changes in the market environment, and there is considerable uncertainty regarding specific sales performance. https://finance.eastmoney.com/a/202603053663192752.html
China Securities Intelligent Finance – China Pharmaceutical(600056) announced on March 6 that its wholly-owned subsidiary, Tianfang Pharmaceutical Co., Ltd., recently received two “Approval Notices for Supplementary Applications” for minoxidil liniment issued by the National Medical Products Administration, becoming the marketing authorization holder for the drug. The announcement indicates that minoxidil topical solution is a dermatology and ENT medication used to treat male pattern baldness and alopecia areata. The National Medical Products Administration (NMPA) accepted a supplementary application for a change of marketing authorization holder for this drug in January 2026, and the project has accumulated an investment of approximately 6.45 million yuan as of the date of this announcement. According to the third-party database Menet, the drug’s sales in China’s three major terminals and six major markets reached approximately 447 million yuan in 2024, and approximately 315 million yuan in the first three quarters of 2025. The company stated that ...
On the evening of March 5th that Zhejiang Medicine…(600216) issued an announcement stating that its subsidiary, Zhejiang Xinma Biopharmaceutical Co., Ltd. (hereinafter referred to as “Xinma Bio”), has initiated a single-arm, open-label phase II clinical study on the efficacy and safety of its injectable recombinant humanized anti-CD70 monoclonal antibody-AS269 conjugate (ARX305) for relapsed/refractory lymphoma. Zhejiang Medicine stated that the recombinant humanized anti-CD70 monoclonal antibody-AS269 conjugate for injection (ARX305) is a new generation monoclonal antibody-drug conjugate jointly developed by Newcode Biotech and Ambrx, Inc. of the United States, under a “Cooperative Development and Licensing Agreement” signed on October 22, 2019. It is used to treat advanced tumors expressing CD70 and belongs to innovative biotechnology drugs. https://finance.eastmoney.com/a/202603053663319462.html
On March 5, CSPC Pharmaceutical Group (01093) announced that its indacaterol mometasone inhalation powder has been approved by the National Medical Products Administration of the People’s Republic of China to conduct clinical trials in China. This product is primarily used for maintenance treatment of asthma in adults and adolescents aged 12 and above, and has the effects of relaxing smooth muscles and dilating the bronchi. Indacaterol mometasone inhaler powder is the first once-daily ICS-LABA combination inhaler included in the National Medical Insurance Catalog (2022 Edition), providing asthma patients with a more efficient and convenient treatment option. https://finance.eastmoney.com/a/202603053663314598.html
on the evening of March 5th that Harsco Pharmaceutical…(002653) issued an announcement stating that its subsidiary, Shanghai Haishengnuo Pharmaceutical Technology Co., Ltd., recently received the “Drug Clinical Trial Approval Notice” issued by the National Medical Products Administration, with the indication being respiratory diseases. Harsco Pharmaceuticals stated that HSK50042 tablets are an orally administered, potent, and highly selective small molecule inhibitor independently developed by the company. This latest approval for a new indication in the field of respiratory diseases marks another significant milestone in its clinical trials. Preclinical studies have shown that HSK50042 can effectively improve the pathological symptoms of lung diseases in model mice at relatively low doses, demonstrating good efficacy, good tolerability, and a large safety window. It is a drug with great development potential and is expected to provide patients with respiratory diseases with a highly effective and safe new treatment option. https://finance.eastmoney.com/a/202603053663302749.html
On March 5th, Henlius Biotech (02696.HK) issued a voluntary announcement stating that its Investigational New Drug (IND) application for HLX97 (a small molecule inhibitor of KAT6A/B), developed independently, in patients with advanced/metastatic solid tumors, has been approved by the National Medical Products Administration (NMPA). HLX97 is a small molecule inhibitor targeting the lysine acetyltransferase KAT6A/B. Non-clinical studies have shown that it has good anti-tumor efficacy and safety characteristics; currently, there are no similar KAT6A/B small molecule inhibitors approved for marketing globally. This progress marks an important milestone in the company’s innovative oncology treatment pipeline, and clinical research will proceed as planned. Given the long development cycle, high investment, and high risk of new drug development, the company cautions that it cannot guarantee the ultimate successful development and commercialization of HLX97, and investors are advised to be aware of the investment risks. 网址:https://finance.eastmoney.com/a/202603053663239623.html
Drugdu.com expert’s response: The difficulty in obtaining qualifications for Class II and III medical devices lies in high product risks, strict supervision, complex procedures, high professional thresholds, large investment, long cycles, and enterprises often being rejected repeatedly due to insufficient compliance capabilities, non-standard materials, or non-compliance with requirements for premises, personnel, and systems. I. Root Cause: Supervision Intensity Determined by Risk Level Class II (medium risk) e.g., blood glucose meters, electrocardiographs, surgical masks. They contact the human body or carry certain injury risks, requiring registration/filing + strict system management. Class III (high risk) e.g., cardiac stents, artificial joints, ventilators, in vitro diagnostic reagents. Directly related to life safety, requiring strict approval, mandatory clinical trials, and full-chain supervision. II. Process & Approval Difficulty 1. Registration (Most Difficult) Class II: Approved by provincial medical products administrations. Requires product testing + clinical evaluation (some exempt) + system ...
On March 3, the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China showed that Eli Lilly and Company’s application for marketing authorization of its Class 3.1 new drug, Lerechizumab injection, has been accepted.Lebrikizumab is an interleukin-13 (IL-13) inhibitor that selectively targets and neutralizes IL-13 with high binding affinity and a slow dissociation rate. The binding site of lebrikizumab to the IL-13 cytokine overlaps with the binding site of the IL-4Rα subunit in the IL-13Rα1/IL-4Rα heterodimer, thereby preventing the formation of this receptor complex and inhibiting IL-13 signaling. IL-13 is a major cytokine in atopic dermatitis, driving type 2 inflammation in the skin, leading to skin barrier dysfunction, itching, skin thickening, and infection.The development of lericizumab has been a long and winding road. Originally developed by Roche, the drug began its first clinical trial in 2008, but its initial indication of asthma ...
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