In recent years, innovations in the medical and health industry have continued to emerge and have developed into one of the most active industries. 36Kr witnesses and accompanies the growth of innovative companies in this field and brings professional voices to the industry.
To this end, 36Kr launched the "Medical and Health Industry Weekly Report", which will be published regularly to provide readers with industry information from multiple perspectives such as capital, policies, finance, and new products.
Please check the weekly report of the medical and health industry on November 14. The industry weekly report contains the financing news reported by the "36Kr Venture Capital Channel" in the medical and health sector this week, as well as other domestic and foreign industry news that deserve attention.
Investment and financing
Chuangxiang Biotechnology completed a US$21 million Series B financing
36氪 learned that "Chuangxiang Biology" today announced the completion of a US$21 million Series B financing. This round of financing was led by Xiangfeng Investment China Fund, and Ruifu Medical Venture Capital Fund, Kunlun Capital, and Zhongnan Venture Capital jointly participated in the investment. "Chuangxiang Bio" has raised more than US$40 million. The funds raised in this round of financing will be mainly used to promote global clinical research, independent research and development and product introduction. "Inmagene" is a new drug research and development company in the field of immune-related treatments, with branches in Shanghai, Hangzhou and Beijing. Company members have led teams in their respective companies to introduce more than 30 overseas products to China, led the global R&D of more than 20 successful new drugs, obtained NDAs in 28 countries, and obtained 6 INDs for innovative products in China and the United States.
promoted global registration of clinical trials, "Chuangxiang Bio" completed a US$21 million B round of financing
Keya’s Ark completed over 200 million RMB C round of financing
36氪 learned that AI medical company Beijing Keya’s Ark Medical Technology Co., Ltd. (formerly Keya Medical, now abbreviated as: Keya’s Ark) announced the completion of more than 200 million RMB Series C financing. This is also the third round of funding that Keya’s Ark completed within 9 months of this year. This round of financing is led by IDG Capital, with Source Code Capital and Tasly After the joint investment, the original shareholder Yahui Capital continued to invest. Prior to this February, Keya's Ark had received a 100 million yuan investment led by Kunlun Capital; later, in August this year, it received a 150 million yuan B round of financing led by GGV Jiyuan Capital.
36 Krypton first launch | Using artificial intelligence to make the human body’s "GPS", "Keya's Ark" received more than 200 million yuan in Series C financing
Xuanhe Medical completed 15 million yuan in Series A financing
Xuanhe Medical Technology (Shanghai) Co., Ltd. He Medical) completed a 15 million yuan A round of equity investment, exclusively invested by Tianfeng Tianrui. Xuanhe Medical is a medical technology company that provides integrated full-cycle comprehensive diagnosis and treatment service solutions for oncology. It is committed to integrating resources such as biomedical technology, medical treatment, nursing, management and patient education to build a precision cancer diagnosis and treatment center.
Ruike Biotechnology has completed over 100 million U.S. dollars in Series B financing
36氪 learned that "Rike Biology" has recently completed over 100 million U.S. dollars in Series B financing, including dual currency investments in RMB and U.S. dollars. This round of financing was jointly invested by Legend Capital, Jifeng Capital, Sequoia Capital China Fund, Xiangfeng Investment, Haitong Kaiyuan, Cornerstone Capital, Yuansheng Venture Capital, Qingsong Capital, Everbright Holdings and other institutions. The last round of investors was under Oriental Fortune The fund, Shenzhen Woying Investment's fund, and Ningbo Haojin Grant Thornton continued to invest. The funds raised in this financing will be mainly used for the company's key product industrialization base construction, HPV nine-valent vaccine, recombinant new crown vaccine and other product clinical trials, follow-up product pipeline research and development, core technology platform construction and international expansion.
focused on the research and development of genetic engineering vaccines, "Rike Bio" completed more than US$100 million in Series B financing
Houkai Medical completed over 100 million yuan in Series C financing
36氪 learned that Beijing-based minimally invasive surgical solutions provider Houkai (Beijing) Medical Technology Co., Ltd. ("Houkai Medical") has completed a series C financing of more than 100 million yuan, led by Hillhouse Ventures, followed by Gaoke Xinjun, and Haoyue Capital as the exclusive financial advisor. This round of financing is mainly used for technology research and development and to promote the company's sales channel construction and overseas marketing network construction, and to further expand production capacity. Hokai Medical was established in 2010 and started operations only after the founder Shi Wenyong returned to China in 2014. It is a company focused on the research and development of minimally invasive surgical instruments. Its products are mainly ultrasonic surgical scalpels that can be used for open surgery or minimally invasive surgery.
36 Krypton First Release | Minimally Invasive Surgery Ultrasonic Surgery Market Ushers in Domestic Alternatives, "Houkai Medical" Receives Over 100 Million RMB C SeriesFinancing
Yahong Pharmaceutical completed 700 million yuan in round D financing
36氪 learned that innovative drug research and development company "Yahong Pharmaceutical" today announced the completion of the D round of financing, the transaction amount exceeded 700 million yuan. This round of financing was led by Qiming Venture Capital, and the investors included Yunfeng Fund, CICC Chuanhua Fund, Yicun Capital, Hengxu Capital, Hongxin Capital, Gopher Assets, C&D Xinxing Investment, Hanrun Capital, Qinzhi Capital, Yoyin Fund, Hao Shuo Zhi Er, etc. Yahong Pharmaceutical is a drug research and development company focusing on global innovative drug research and development for genitourinary system anti-tumor and related diseases.
36氪 Exclusive | Globalized innovative drugs shine again, "Asia Rainbow Medicine" received Qiming's lead to invest over 700 million yuan in D round of financing
Triassic completed nearly 100 million yuan of A+ round of financing
It is reported that "Triassic" has been recently launched Completed nearly 100 million yuan in A+ round of financing. This round of financing was led by Daotong Investment, and the co-investors included Zheng Xiaodong, chairman of Shanghai Tofflon Technology Co., Ltd., and Yunqi Capital. The funds raised in this round of financing will be mainly used for the development of "Triassic" 3D printing drug products, the Sino-US registration application, and the construction of large-scale production lines.
focuses on 3D printing drug technology, and "Triassic" has completed nearly 100 million yuan of A+ round of financing
Huihe Medical completed nearly 100 million yuan of A round of financing
It is reported that "Huihe Medical" has recently completed nearly 100 million yuan of A round of financing. This round of financing was led by Boyuan Capital, followed by SDIC Capital, Guofang Capital and old shareholder Yuanhe Yuandian. Huaxing Capital served as the exclusive financial advisor for this financing. This is the company's new round of financing following the tens of millions of yuan in angel financing invested by Yuanhe Origin. The funds raised will be used to continue to promote the continuous R&D, clinical approval of tricuspid interventional products, and other structural heart disease related products. Research and development of product pipeline.
independently developed China's first transvascular tricuspid valve interventional repair system, "Huihe Medical" completed nearly 100 million yuan in round A financing
Yingsheng Bio completed hundreds of millions of yuan in round B financing
36氪 learned that clinical mass spectrometry technology service provider Shandong Yingsheng Biotechnology Co., Ltd. has completed hundreds of millions of yuan in Series B financing, led by Hillhouse Ventures, followed by Chende Capital, Sunshine Ronghui Capital, Huimei Capital, Qianhai Fund of Funds, and Yuansheng Ventures and other old shareholders continue to raise funds , Haoyue Capital acted as the exclusive financial advisor. After the completion of this round of financing, Yingsheng plans to accelerate market expansion in the field of mass spectrometry, expand the industry chain and technical team, and build a full line of clinical mass spectrometry applications on this basis.
36氪 First Release | Provide integrated clinical mass spectrometry solutions, "Inion Biotech" received hundreds of millions of yuan in Series B financing
Jingjie Biotechnology completed 530 million yuan of Series B financing
36氪 learned that "Jingjie Bio" has recently completed 530 million yuan Yuan B round of financing. This round of financing was led by IDG Capital, followed by well-known investors such as Fortune, Honghui Capital, and Suzhou Longmen Venture Capital. The previous round of lead investor SDIC Ventures continued to invest. This round of financing is the second round of financing completed by "Jingjie Bio" after the first round of financing led by SDIC Ventures at the beginning of the year, followed by Boyuan Capital, with a total of 660 million yuan. The funds raised will be mainly used for further promotion Its new business line development, market expansion and team optimization.
focused on the development and application of proteomics technology, "Jingjie Bio" completed 530 million yuan in Series B financing
Jinfeng Bio completed US$10 million in Pre-A round of financing
It is reported that "Jinfeng Bio" has recently completed one thousand Ten thousand USD Pre-A round of financing. The investors in this round of financing are mainly Hanyi Capital and Hongli Venture Capital. The funds raised will be mainly used for the upgrade of the "Jinfeng Bio" technology platform, the construction of the patent pool and the construction of related teams. "Jinfeng Bio" is a tumor cell therapy product developer. It is committed to the development and application of non-invasive tumor detection and screening in the field of precision cell therapy, using biological information technology and artificial intelligence technology to deeply mine tumor multi-omics data and optimize Cell therapy strategy to improve the effectiveness of tumor treatment.
uses a new generation of TILs therapy to treat solid tumors, "Jianfeng Bio" has completed a $10 million Pre-A round of financing
Policies and Regulations
The State Food and Drug Administration issued the "Announcement on the Pilot Application of Electronic Registration Certificates for Medical Devices"
The Bureau issued the "Announcement on the Pilot Application of the Electronic Registration Certificate for Medical Devices" and decided to issue the electronic registration certificate for medical devices in the pilot. It clearly pointed out that during the pilot period, the medical device electronic registration certificate and the paper medical device registration certificate are issued simultaneously, and both have the same legal effect. This pilot is based on the earlier national electronic license technical standardsRealize the full-featured application. After going online, enterprises can view and download the electronic registration certificate of medical devices online without waiting for mailing. Relying on the national electronic certificate and license sharing service system, the electronic registration certificate can realize cross-departmental and cross-regional certificate sharing and mutual recognition, and various business departments of the State Drug Administration can also directly retrieve from the electronic certificate database.
The General Office of the National Health Commission cancels the issuance of the "Approval for the Establishment of Medical Institutions" for some medical institutions. The notice stated that it would cancel the issuance of the "Approval for the Establishment of Medical Institutions" for some medical institutions, and require localities to establish a blacklist system for the medical and health industry to strengthen the recording, publicity and early warning of untrustworthy behavior.
New product approved
Eisai's lenvatinib was approved for the treatment of thyroid cancer. The second indication was approved in China.
According to the notice issued by the China National Medical Products Administration (NMPA), Eisai’s lenvati Ninety received a new approval number for the drug to treat differentiated thyroid cancer. Lenvatinib is a multi-target tyrosine kinase inhibitor that can block a series of targets in tumor cells including VEGFR1-3, FGFR1-4, PDGFRα, KIT, and RET.
Huahai Pharmaceutical's application for the listing of category 4 generic olanzapine tablets was approved.
According to the information on the NMPA official website, Huahai Pharmaceutical's application for the listing of category 4 generic olanzapine tablets was approved. Olanzapine is a large variety of neurological drugs with more than 4 billion. Among them, ordinary tablets entered the first batch of national centralized procurement catalogs, and orally disintegrating tablets entered the third batch of national centralized procurement catalogs.
China Resources Shuanghe Pregabalin Capsules Generic Drug Application Approved.
Pregabalin is clinically mainly used for diabetic peripheral neuropathy-related neuralgia, post-herpetic neuralgia, adjuvant treatment of adult partial epilepsy, generalized anxiety Disorders, neuropathic pain and fibromyalgia of spinal cord injury. The original manufacturer Pfizer's Pregabalin (trade name: Lyrica) was approved in the EU in July 2004 and in the United States in December of the same year. Lyrica's peak sales exceeded 5 billion U.S. dollars. After the patent expired, sales fell severely due to the impact of American generic drugs. In 2019, it was 3.321 billion U.S. dollars.
Xinlitai Dapoxetine Hydrochloride Tablets generic drug listing application was approved. The original manufacturer of
Dapoxetine Hydrochloride is Janssen, which is mainly used to treat male premature ejaculation (PE). PE is a common male sexual dysfunction disease with a high incidence, which has a serious impact on patients' physical and mental health and quality of life. Dapoxetine hydrochloride has good clinical benefits, low safety risks, and has the advantages of rapid onset, rapid clearance and low drug accumulation.
Nuohui Health's colon cancer early screening product Chang Weiqing obtained the medical device registration certificate
Nuohui Health's colon cancer early screening product Chang Weiqing-"KRAS gene mutation and BMP3/NDRG4 gene methylation and fecal occult blood joint detection reagent Box (PCR fluorescent probe method-colloidal gold method)" medical device registration certificate (in vitro diagnostic reagent) was officially approved by NMPA. The intended use of the kit is: in vitro qualitative detection of KRAS gene mutations (including but not distinguishing G12D, G12A, etc.), BMP3 and NDRG4 gene methylation and hemoglobin in human fecal samples. The detection value of each index passes "KRAS gene mutation and BMP3/NDRG4 gene methylation and fecal occult blood combined detection and analysis software" calculates a comprehensive score, which is used to screen high-risk groups of colorectal cancer with poor compliance with colonoscopy.
Shukun's coronary CTA assisted triage software was approved for NMPA Class III.
Shukun's coronary CT angiography image vascular stenosis assisted triage software (Sukun Cardiovascular AI) was officially approved by the National Medical Products Administration Three types of certificates, this is also the world's first medical device registration certificate in the AI field of cardiac coronary stenosis.
Eli Lilly’s new coronavirus neutralizing antibody Bamlanivimab received FDA emergency use authorization
Eli Lilly’s new coronavirus neutralizing antibody Bamlanivimab (LY-CoV555) 700mg received FDA emergency use authorization (EUA) for the treatment of mild to moderate adult and pediatric patients aged 12 years and over COVID-19, weighing at least 40 kg (approximately 88 pounds), these patients are at higher risk of progression to severe and/or hospitalized COVID-19, including people over 65 years of age and patients with chronic diseases. Patient SARS-CoAfter the V-2 virus test is positive, Bamlanivimab should be treated as soon as possible within 10 days of the onset of symptoms.
Guichuang Medical’s drug-eluting PTA balloon dilatation catheter product was approved to be marketed
NMPA official website news shows that Zhejiang Guichuang Medical Device Co., Ltd.'s innovative product "drug-eluting PTA balloon dilatation catheter" has been approved for registration. The product is a guide wire balloon dilatation catheter, which consists of an end, a balloon imaging point, a balloon and drug coating, a catheter and a catheter base, and is coated with paclitaxel drug. The product is sterilized by ethylene oxide for one-time use. It is suitable for percutaneous transluminal angioplasty for patients with stenosis or occlusion of femoral artery and popliteal artery (except inferior knee artery).
Chia Tai Tianqing Group 3 Generic Pomalidomide Capsules Approved The application submitted by
Chia Tai Tianqing Group 3 generic pomalidomide capsules was approved by the State Food and Drug Administration to become the first domestic imitation. Pomalidomide belongs to the third generation of immunomodulators (IMiD), which is an IMiD similar to thalidomide and lenalidomide. Although the chemical structure is similar, pomalidomide is resistant to lenalidomide Multiple myeloma is effective.
Yuandong Bio-Memantine Hydrochloride Sustained-Release Capsules and Capecitabine Tablets Approved for Marketing
Yuandong Bio-Bio's 2 generic drugs were approved for marketing by the National Food and Drug Administration, namely Memantine Hydrochloride Sustained-Release Capsules and Capecitabine Tablets. Among them, Memantine Hydrochloride Sustained Release Capsules have been declared for the market in three categories, making it the first domestic product of this dosage form. Memantine Hydrochloride Sustained-Release Capsules is a class 3 chemical medicine used to treat moderate to severe Alzheimer's dementia. Capecitabine is a class 4 chemical drug used for the first-line treatment of inoperable advanced or metastatic gastric cancer, the first-line treatment of metastatic colorectal cancer, single-agent chemotherapy and combination chemotherapy for breast cancer.
Qingfeng Pharmaceutical's propofol fumarate tenofovir tablets was approved for listing.
Jiangxi Qingfeng Pharmaceutical's application for the listing of three types of generic propofol fumarate tenofovir tablets was approved by the State Food and Drug Administration, becoming a domestic The second drug manufacturer approved after Chengdu Beite. Tenofovir fumarate tablets (TAF) is a new type of tenofovir targeted prodrug. Studies have shown that its antiviral effect is similar to Gilead Tenofovir disoproxil fumarate (TDF). But the dosage is only one tenth of the latter.
Others
Pfizer/BioNTech's new crown vaccine phase III study is successful: 90% protection
On November 9, Pfizer and BioNTech announced the results of the first phase of the interim analysis conducted by the external independent Data Monitoring Committee (DMC) on November 8. It shows that its mRNA candidate vaccine BNT162b2 has proven its efficacy in preventing COVID-19 in healthy subjects who have not been infected with SARS-CoV-2 virus. A stratified analysis of the vaccinated and placebo population found that the protection rate of the second dose of BNT162b2 vaccine 7 days after vaccination reached more than 90%, which means that effective protection can be obtained 28 days after vaccination of BNT162b2 vaccine.
Editor: Dun Yuting
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