Medical and health industry weekly report|Biocytometer received 970 million yuan in D+ round of financing; China Food and Drug Administration released "High-throughput Sequencer Standards"; Junshi Biologics monoclonal antibody was approved by FDA orphan drug_detailed interpretation_news_hot events_ 36 krypton
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Medical and health industry weekly report|Biocytometer received 970 million yuan in D+ round of financing; China Food and Drug Administration released “High-throughput Sequencer Standards”; Junshi Biologics monoclonal antibody was approved by FDA orphan drug_detailed interpretation_news_hot events_ 36 krypton

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In recent years, innovations in the medical and health industry have continued to emerge and have developed into one of the most active industries. 36 krypton has witnessed and accompanies the growth of innovative companies in this field, and has brought 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, policy, finance, and new products.

Please check the weekly report of the medical and health industry on September 20. 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. Enjoy

Investment financing

September 13, HangzhouShangjian BiologicalTechnology Co., Ltd. (Shangjian Biological) announced the completion of 220 million yuan in Series B financing. This round of financing was led by Yida Capital, jointly led by Tongchuangweiye and Huarui Investment, Bank of Communications International, Haoshuo Investment, Dynamic Balance Capital, etc. Institutions participate together to help the R&D and industrialization of Sunkin Bio’s innovative drugs. Xingyuan Zhitong acted as the exclusive financial advisor for this round of financing. This round of financing is to promote clinical trials of existing varieties and accelerate the construction of Hangzhou antibody drug production base.

It was learned on September 14 that Zhejiang Yunkai Yamei Pharmaceutical Technology Co., Ltd. announced that it has completed a US$30 million B+ round of financing, with the exclusive investment of Changling Capital and Huaxing Capital as the exclusive financial advisor for this round of financing. This round of financing is mainly used to further consolidate the online service system and patient scale of existing disease lines, while expanding more vertical diseases of chronic diseases.

September 14, ShenzhenZifu MedicalTechnology Co., Ltd. announced the completion of hundreds of millions of yuan in Series C financing. This round of financing was led by Jinglin Investment, Bojiang Capital, Investment Control Donghai Investment, Yifeng Capital, BeidouStar InvestmentFollow the vote. This round of financing will be used to further promote the company’s non-invasive gastrointestinal inspection and intelligent diagnostic product research and development, market promotion and expansion of reproduction.

Aiming at the research and development of capsule endoscopes, “Zifu Medical” completed hundreds of millions of yuan in Series C financing

It was learned on September 14 that Nanjing Qingpu Biotechnology Co., Ltd. announced the completion of a pre-A round of financing of nearly RMB 50 million. This round of financing was led by Legend Capital. Angel shareholder Yingdi Capital continued to participate in the investment. This round of financing will be mainly used to promote the IND application and early clinical research of existing projects, further expand the team size, enrich the R&D pipeline, and accelerate product development.

September 15th, BeijingBiosetGene Biotechnology Co., Ltd. announced that it has completed a D+ round of financing of 970 million yuan. This round of financing was led by CMB International, followed by SDIC Ventures, China Life Equity, Bencao Capital, Tongchuang Weiye and Pax Capital. Dr. Shen Yuelei, Chairman and CEO of Biocytometer, said: “The funds raised in this round will strongly support the rapid implementation of the “A Thousand Rats Resistance” program. With the advancement of the program, Biocytometer will cooperate with many domestic and foreign pharmaceutical R&D companies , To accelerate the development and marketing of innovative drugs to benefit the majority of patients.”

Focusing on the cooperative development of new drugs, “Biocytometer” completed a D+ round of financing of 970 million yuan

September 15Jingfeng MedicalAnnounced the completion of a pre-B round of financing of more than 100 million yuan. This round of financing is led by Sanzheng Health, with the follow-up investment from Guoce Investment, Lenovo Star, and Poly Capital. It is “Jingfeng Medical” following the 2019 A round of financing and April 2020 A new round of financing after the A+ round of financing. The financing will be mainly used to promote the development of Jingfeng minimally invasive surgical robot products.

Focusing on minimally invasive surgery platform products, “Jingfeng Medical” completed a pre-B round of financing of over 100 million yuan

On September 16, Jingyi Technology has completed a total of 430 million yuan in Series D financing. This round of financing was led by Tencent, and Longmen Capital and its old shareholders Deyi Capital, Zhenghai Capital, Meihe Zhongbang, and Jiaxing Guangrun also participated in the investment. It is understood that Shanghai Jingyi Technology Co., Ltd. is a leading domestic smart medical technology and service provider. It was founded in 2004 and is one of the member companies of the Jingyi Group. Its business scope covers smart wards, HRP,Medical cloudIn many fields, we will comprehensively deploy digital hospitals and regional smart medical care.

Providing smart medical technology and services, “Jingyi Technology” completed a round D financing of RMB 430 million

On September 16, Shanghai Aopeng Medical Technology Co., Ltd., a company focusing on intravascular interventional surgical robots, announced that it has completed a round of financing of nearly 100 million yuan. It is reported that this round of financing will be mainly used to start human clinical trials, hardware and software R&D investment, and CE certification.

It was learned on September 17 that Yinzhu Pharmaceutical recently completed a 45 million yuan A round of financing, with a pre-investment valuation of 1.6 billion yuan. This round was jointly invested by Shanghai Kuntai Capital and Shenzhen Qiandeng Capital, and Zhongtong Capital served as the exclusive financing advisor for this round. Yinzhu Pharmaceutical is a research and development company of new anti-tumor drugs, mainly engaged in the research and development of new anti-tumor drugs.

On September 17, Runde Education, a major healthcare vocational education brand, announced the completion of a round A financing of 100 million yuan. The investor was SAIF Investment Fund and Mamba Capital served as the exclusive financial advisor. This round of financing will be used for new product development and promotion, smart teaching system research and development, investment and mergers and acquisitions.

36氪 First Release | Last year, the growth rate of training medical and nursing students exceeded 220%, Runde Education completed 100 million yuan in financing

On September 18, Shenzhen Tajirui Biopharmaceutical Co., Ltd., a leading company in targeted anticancer drugs, announced the completion of a strategic financing of nearly 100 million yuan, with Hongtai Fund leading the investment. This round of funding will be mainly used for the company’s clinical research on small-molecule targeted drugs for the treatment of chronic myelogenous leukemia (chronic myeloid, CML) and small-molecule targeted drugs for the treatment of non-small cell lung cancer (NSCLC), as well as other latest-generation targeted drugs Research and development, etc.

Focusing on the research and development of anti-drug resistance targeted new drugs, “Tajirui” completed nearly 100 million yuan in strategic financing

On September 18, Kerry Corning announced the completion of US$40 million in Series C financing. This round of financing was led by Panacea Venture, with Huachuang Yida Biomedical Fund, Oriental Hongtai Capital and Sany Innovation as a follow-up investor. Existing investors JJDC, China Economic Cooperation Group, WuXi AppTec and KTB Network also participated in this round of investment. The funds raised in this round will be used for the clinical development of the company’s two leading research projects XW10172 and XW10508.

Focusing on the treatment of neurological diseases, “Kerry Corning” completed US$40 million in Series C financing

Policies and regulations

On September 11, in order to implement the “Opinions on Deepening the Reform of the Review and Approval System to Encourage Innovation in Drugs and Medical Devices” and “Opinions on Strengthening the Protection of Intellectual Property Rights” to explore the requirements for establishing a drug patent linkage system, the State Food and Drug Administration and the State Intellectual Property Office Organized the drafting of the “Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (Trial) (Draft for Solicitation of Comments)”, which is now open to the public for comments.

On September 14, the State Food and Drug Administration issued the “Announcement of the General Administration of Customs of the State Food and Drug Administration on the Establishment of Wuxi Air Port and Jiangyin Port as Drug Import Ports”: 1. From the date of this announcement, except for the “Drug Import Administration” In addition to the drugs prescribed in Article 10 of the Measures, other imported drugs (including narcotic drugs and psychotropic drugs) can be imported through the Wuxi Air Port and Jiangyin Port. 2. Increase the Wuxi Municipal Market Supervision and Administration Bureau as the port drug supervision and management department, which will be responsible for the specific work of drug import filing at Wuxi Air Port and Jiangyin Port. 3. Add Wuxi City Drug Safety Inspection and Testing Center as a port drug inspection agency. Since the date of this announcement, the Wuxi Drug Safety Inspection and Testing Center has begun to undertake the inspection of drugs at the Wuxi Air Port and Jiangyin Port.

It was learned on September 15 that the National Medical Products Administration officially released the first domestic medical device industry genetic sequencer standard-“High-throughput Sequencer Standard”. The content includes the scope of high-throughput sequencer, normative references, classification, requirements, test methods, labels and instructions for use, packaging, transportation, storage, and references. Its official release indicates that the clinical application of gene sequencers and gene sequencing technologies will gradually enter a mature stage, laying a strong foundation for the development of industry norms and the wide application of sequencing technologies, and at the same time, it will help more gene sequencing technologies and products enter clinical applications. Benefit the public.

It was learned on September 15 that the National Health Commission issued the “Extracorporeal Membrane Oxygenation (ECMO) Technology Clinical Application Management Regulations”. The “Specifications” pointed out that medical institutions that carry out ECMO technology must have an intensive care unit or an intensive care unit, with more than 3 professional and technical personnel who have passed the ECMO technical training and assessment, including at least two practicing physicians. It is also necessary to have equipment, facilities and capabilities to carry out D-phase cardiac function testing of heart failure and continuous cardiac output monitoring. In terms of personnel, they must be in-service physicians in internal medicine, surgery, emergency medicine, critical care medicine, pediatrics, anesthesiology and other medical institutions, and have been engaged in clinical work in related majors for more than 5 years.

On September 15, 2020, the National Health Commission issued the “Notice on Strengthening the Administration of Narcotics and Class I Psychotropic Drugs in Medical Institutions.” The “Notice” is based on the main problems existing in the management of hemp essence drugs in medical institutions, and puts forward specific requirements in seven aspects: 1. Attach great importance to the management of hemp essence drugs; 2. Improve the management system of hemp essence drugs in medical institutions; Management of all aspects of the whole process of fine medicine; 4. Standardize the prescription authority and use operation management of hemp medicine; 5. Meet the clinically reasonable demand for hemp medicine; 6. Improve the information management level of hemp medicine; 7. Strengthen supervision, guidance and responsibility Hold accountable. The purpose of the notice is to strengthen the management of narcotic drugs and first-class psychotropic drugs (hereinafter referred to as anesthetic drugs) in medical institutions, ensure reasonable clinical needs, and strictly prevent the flow into illegal channels.

On September 16, the State Food and Drug Administration issued an announcement stating that there was a problem that the company failed to submit a rectification plan for the defects found in inspection and make effective rectification as required in the product of nifuratel. The process is not completely consistent with the declared process, which affects the key quality attributes of the product. It does not meet the requirements of my country’s “Good Manufacturing Practice for Drugs (Revised in 2010)”. According to the relevant provisions of the “Drug Administration Law of the People’s Republic of China”, the State Drug Administration has decided to suspend the import, sale and use of POLICHEMS.RL nifuratel tablets and nifuratel vaginal tablets from now on.

It was learned on September 17 that the Comprehensive Team of the State Council’s Joint Prevention and Control Mechanism for the Prevention and Control of the Novel Coronavirus Pneumonia Epidemic issued the “New Coronavirus Pneumonia Prevention and Control Plan (Seventh Edition).” Compared with the sixth edition, the new “Program” adds the definition of close contacts of close contacts. In addition, in terms of specimen collection and laboratory testing, the new “Proposal” added genetic sequencing, requiring that the first cases in various regions and cases with unknown sources of infection and positive specimens found in environmental monitoring should be traced to sources such as genetic sequencing.

It was learned on September 17 that the Statistical Information Center of the National Health Commission issued the “Notice on the Publicity of the Evaluation Results of the National Medical and Health Information Interconnection Standardization in 2019”. The “Notice” shows that in the list of regions, there are 27 regions in 2019. It was awarded the four-level A (prefecture-city or district-county level), and 4 regions were awarded the fourth-level B (prefecture-city or district-county level). In the list of hospitals, 6 hospitals including Pediatrics Hospital of Fudan University, Shanghai Chest Hospital, Wuhan Central Hospital, Shenzhen Baoan District Maternal and Child Health Hospital, Peking University Shenzhen Hospital, and West China Second Hospital of Sichuan University were awarded Grade 5 B Etc., 148 hospitals were awarded the fourth-class A, and 10 hospitals were awarded the fourth-class B.

It was learned on September 17 that the National Medical Insurance Administration issued the “Guiding Opinions on Establishing a Pharmaceutical Price and Recruitment Credit Evaluation System”, requiring all localities to establish and implement a medical price and recruitment credit evaluation system by the end of 2020. The “Opinions” clarified that the medical price and credit evaluation system for recruitment and procurement is different from the traditional credit supervision based on administrative management. It is based on the purchase and sale contract relationship of centralized procurement of drugs and medical consumables. Rebates in pharmaceutical companies violate fairness, reasonableness, and honesty. In the case of credit pricing, the centralized purchasing agency for medicines and medical consumables shall take measures in accordance with credit commitments to safeguard the legitimate rights and interests of purchasers and consumers.

It was learned on September 17 that, under the guidance of relevant departments, the Institute of Security of China Academy of Information and Communications Technology has joined forces with the Health Information Security and New Technology Application Professional Committee of China Health Information and Healthcare Big Data Society, and Tencent Security and Data Protection Officer (DPO) ) Community, jointly compiled and released the “Digital Medical Network Security Observation Report (2020)”. The report aims to provide work ideas and suggestions for the health and medical industry authorities, medical institutions and security service vendors through comprehensive and objective research on the industry security situation, and support the safe and orderly development of the digital medical industry. The Security Research Institute of China Academy of Information and Communications Technology will continue to pay attention to the changing trend of digital medical network security risks, carry out security observation research and situation research in the field of industrial integration, and regularly release research results to the market, provide security services, and welcome industry colleagues to communicate and cooperate to jointly promote health The overall safety level of the medical industry has been improved.

Acquisition and transfer

It was learned on September 14 that Sunshine City issued an announcement stating that Taikang Life and Taikang Pension, subsidiaries of the insurance giant Taikang Insurance Group, and Sunshine City’s second largest shareholder Shanghai Jiawen Investment Management Co., Ltd. signed a “Share Transfer Agreement” and agreed to transfer 13.53% of the shares of the listed company, a total of 555 million shares, at a transfer price of 6.09 yuan per share, a discount of 18.03% from the closing price of 7.43 yuan per share on the day, and the share transfer price is approximately 3.378 billion yuan (tax included). In this plan to introduce strategic investment, Sunshine City has set a very attractive performance commitment and bound it with the core management employee stock ownership plan.

September 15th, biomedical manufacturing companyGuofa sharesPost an article about acquisitionGoldman SachsThe report (draft) proposed to purchase a 99.9779% stake in Goldman Sachs Biotech held by 8 people by issuing shares and paying cash. The transaction price is about 356 million yuan. After the transaction is completed, Guofa shares will add DNA testing business. At present, the reorganization has been conditionally approved by the China Securities Regulatory Commission.

Learned on September 17,Junshi BioAnnouncement, the company signed the “Technology Transfer and Cooperation Agreement” with Weijing Biomedical Technology (Shanghai) Co., Ltd., and Weijing Bio will designate the four drug projects codenamed WJ1024/WJ1075, WJ05129, APL1898, 50% of WJ13404 When the equity is transferred to the company, the company will obtain the exclusive production rights, entrusted production rights and sales rights of the above-mentioned drugs on a global scale. The company will pay a 36 million yuan down payment to Weijing Bio, and will make a milestone payment of no more than 436 million yuan to Weijing Bio based on the progress of research and development and commercialization. Since the commercialization of each drug, the company will pay a sales commission of 50% of the net profit of the product sales to Weijing Bio.

On September 17, Fosun Pharma announced that its subsidiary, Fosun Pharmaceutical Industry, intends to acquire the entire equity of the target company Yiyanyun (Shanghai) Medical Technology from Fosun Healthcare for RMB 4.5 million in cash. According to the announcement, the target company is mainly engaged in the development of digital application platforms in the big health field. The purpose of this transaction is to strengthen the Group’s digital capabilities in drug R&D project management, further improve the drug R&D system and improve management efficiency.

Business cooperation

It was learned on September 14 that the Shanghai Mental Health Center has reached a strategic cooperation with Manlang Medical, a subsidiary of Luye Life Sciences, to jointly implement the internationally leading mental psychotherapy system and model in China and create characteristics suitable for the Chinese population.Evidence-based medicineTreatment projects and multidisciplinary integrated medical service system. A major focus of this cooperation is to introduce Manlang Medical’s multidisciplinary diagnosis and treatment services based on evidence-based medicine into China, and effectively transform the treatment projects that integrate spiritual, psychological, physical, group and expressive art therapy into the actual situation in China. And landing. At the same time, with the help of the online + offline service model, comprehensive multidisciplinary diagnosis and treatment integrated services in the field of children, adolescents, and adults with mild to moderate mental and mental illnesses will be fully implemented to jointly create a personalized psychology evidence-based treatment specialty for the Chinese population.

On September 14, Ping An Dianchuang International Financial Leasing Co., Ltd., a subsidiary of Ping An Medical Health Management Co., Ltd., and Sysmex Medical Electronics (Shanghai) Co., Ltd. signed a strategic cooperation agreement. In the future, the two parties will work on supply chain finance, channel expansion and ” The new model of “trade + finance” has launched comprehensive cooperation in many fields, and formed a resonance of industrial advantages in IVD subdivisions such as blood and blood coagulation.

On September 15, Penguin Almond and China Resources Capital formally announced the joint establishment of Tengkang Medical Industry Fund, with a total scale of RMB 1 billion. This fund mainly focuses on the general health field, focusing on the resources of China Resources and Penguin Almond, investing in related medical targets such as primary medical care, specialty medical care and new medical formats.

On September 15, JD Health, the Health Commission of Taicang City, Jiangsu Province, and the Suzhou Branch of Agricultural Bank of China formally signed a tripartite strategic cooperation agreement. In the future, the three parties will carry out comprehensive strategic cooperation in the field of “Internet + Medical Health” to jointly build a “healthy Taicang” . Among them, JD Health will join hands with the Taicang Municipal Health Commission to develop the “Internet + Medical Consortium” to aggregate the advantages of medical institutions at all levels to realize the reasonable allocation of high-quality medical resources; at the same time, relying on the “Internet + Medical Consortium”, both parties will also Promote the implementation of a series of projects such as Internet hospitals, prescription circulation platforms, Internet + nursing services, and Internet + telemedicine poverty alleviation platforms.

On September 16, Yingshi Biotechnology (Nanjing) Co., Ltd. and Nanjing Yaoshi Technology Co., Ltd. announced that they have reached a strategic cooperation agreement on innovative drug development. According to the agreement, Yashi Technology will transfer the ownership of the five compounds to Yingshi Bio, and Yingshi Bio will have exclusive and exclusive development, production and commercialization rights for these compounds on a global scale. The two parties will carry out joint research and development of the above-mentioned compounds in the pre-clinical stage, and after advancement to a certain stage, the subsequent clinical transformation, manufacturing and commercialization of Yingshi Biological. At the same time, the two parties will jointly develop first-in-class targets with new mechanisms and differentiated products with significant clinical value based on clinical needs and scientific progress in disease biology.

On September 16, Chengdu Leading Drug Development Co., Ltd. andTaslyPharmaceutical Group Co., Ltd. jointly signed an alliance agreement on innovative drug development in Chengdu, and held a seminar on “Focus on clinical needs, adhere to technology leadership, and create innovation clusters”. According to the agreement, Chengdu Pioneer is based on the existing DNA-encoded compound library (DEL) new drug development technology platform, focusing on hot topics such as tumors and immunity, and the two parties have complementary R&D technical capabilities to build a multi-dimensional business cooperation model in new drug R&D cooperation, such as commissioning Development model, joint development model, etc., build a close cooperation and create a win-win alliance, and work together to develop innovative drugs in China.

On September 16, digital health company Health2Sync and pharmaceutical giant Sanofi reached a cooperation, aiming to apply the digital solutions provided by Health2Sync to 300 clinics and hospitals certified by the diabetes shared care network in Taiwan in the next three years. As part of the cooperation, Health2Sync will provide medical staff with patient management software in 300 Sanofi contracted clinics and hospitals, and provide patients with mobile applications to achieve integrated and digital diabetes management.

On September 16, Qingdao Baiyang Pharmaceutical Co., Ltd. and ShanghaiEllisPharmaceutical Technology Co., Ltd. signed a strategic cooperation agreement. This cooperation mainly revolves around the commercialization of innovative drugs and capital cooperation. In terms of commercialization cooperation, Baiyang will provide Alice Pharmaceuticals with overall solutions in terms of patent drug listing, national DTP pharmacy channel services, hospital access and supply chain services, etc., to help Alice Pharmaceuticals achieve end-market coverage of innovative products , Quickly enter the application scenario. In terms of capital cooperation, the two parties will discuss in-depth cooperation in capital areas such as equity and investment, and build various forms of capital cooperation, with a view to maximizing the value of both parties in the pharmaceutical market.

On September 16, Angel Medical Holding Group and Sichuan University formally reached a strategic cooperation, and held a signing ceremony at the Wangjiang campus of Sichuan University, announcing the establishment of 110 million “Sichuan University Angel Education Development Fund”. It is reported that the 110 million yuan Sichuan University Angel Education Development Fund will be used for medical personnel training and scientific research and technological innovation, encouraging Sichuan University’s obstetrics and gynecology, pediatrics, emergency medicine, critical care medicine, anesthesiology, reproductive medicine and other majors The outstanding teachers and students of, support the further expansion of their academic and scientific research work, and promote the development of medical and public health.

September 17, GSKConsumer insuranceJianpin announced andAlibabaAlimama, the digital marketing platform of the group, signed the Joint Business Plan (JBP, Joint Business Plan) and joined the ranks of Alibaba’s “digital captain”. The two parties will launch in-depth cooperation covering two major areas of marketing and business. While building marketing value, it will also explore consumer upgrade operations and business growth models.

On September 17, at the 2020 China International Health and Nutrition Expo held in Guangzhou, China, State Control Star Shark announced the establishment of a strategic partnership with the well-known Japanese listed company Morishita Rentan Co., Ltd. Morishita Rentan designated State Control Star Shark as its strategic species Bifina Jingqiu Probiotics is the exclusive distributor in China and is fully responsible for the business in China.

On September 17, the biopharmaceutical company UCB announced the signing of a strategic cooperation with Alibaba Health. The two parties will rely on the synergistic ecological advantages of Alibaba Health’s platforms in the field of Ushibe’s strong treatment to provide patients with chronic diseases with intelligent online one-stop closed-loop services . Utimes’s “Life for Epilepsy” account is currently online on Alipay. The two parties plan to implement process reengineering to achieve “one-stop cloud diagnosis, treatment and medication” for patients with epilepsy, and open up all the information from initial diagnosis and follow-up diagnosis to prescription, medication and daily care. Manage the whole disease course to improve patient experience.

It was learned on September 18 that GuangzhouBaishi MedicalTechnology Co., Ltd. and RADLogics, an AI medical imaging workflow manufacturer in Silicon Valley, USA, have formally reached a strategic cooperation. The two parties will work together to carry out all-round long-term cooperation in resources, markets, technology, internationalization, etc., to jointly develop a new pattern of AI-enabled medical imaging.

Product and clinical approval

It was learned on September 14 that CanBridge announced that it has obtained the approval of the National Medical Products Administration (NMPA) of China for Hunterase (Idursulfase β injection) for the treatment of patients with mucopolysaccharide II (MPS II or Hunter syndrome). Hunterase is an enzyme replacement therapy (ERT) used for long-term treatment of Hunter syndrome. This is the first new drug approved in CANbridge’s rare disease portfolio and the first enzyme replacement (ERT) treatment provided by China for Hunter syndrome, filling the gap where there is no new drug.

It was learned on September 14 that the official website of the State Food and Drug Administration showed that the olanzapine tablets of Hebei Longhai Pharmaceutical were approved for the application of imitation 4 types of olanzapine tablets. Up to now, there are 10 manufacturers of Olanzapine Tablets, of which 8 are domestic companies, including Jiangsu Haosen Pharmaceutical Group, Qilu Pharmaceutical, Sichuan Kelun Pharmaceutical, and Chengdu Yuandong Biopharmaceutical.

September 14,Yasheng PharmaceuticalAnnounced that the U.S. FDA granted its original innovative drug APG-115 orphan drug designation for the treatment of gastric cancer. This is the first time that APG-115 has been granted orphan drug designation by the FDA. It is the third drug that Ascent Pharmaceuticals has obtained the FDA orphan drug qualification, and it is also the fourth item that Ascent Pharmaceuticals has obtained from the FDA in less than 6 months. Orphan drug qualification certification.

On September 14, Tonghua Dongbao announced that its clinical application for super fast-acting insulin lispro injection (THDB0206) was accepted by the CDE. Super fast-acting insulin lispro injection (THDB0206) belongs to a new generation of fast-acting insulin analogue products. At present, the only similar drugs in the world are Fiasp of Denmark Novo Nordisk and the United StatesEli LillyThe company’s Liumjev, their distinguishing feature is faster and better drug absorption, so that insulin takes effect more quickly, which is closer to the physiological insulin secretion after a meal.

September 14,Hengrui MedicineThe category 4 generic drug valsartan and amlodipine tablets (I) was approved by the State Food and Drug Administration for marketing, becoming the third domestic manufacturer of this product after Baiao Pharmaceutical and Huayuan Pharmaceutical. Valsartan and amlodipine tablets were originally developed by Novartis. It is a single compound tablet composed of angiotensin receptor antagonist valsartan and calcium channel antagonist amlodipine. It is suitable for valsartan monotherapy or ammonia Clodipine monotherapy in patients who fail to adequately control blood pressure.

On September 15, Amgen/BeiGeneA new class 1 drug AMG 199 has been approved for clinical use in China and is intended to treat MUC17-positive gastric cancer or gastroesophageal junction (G/GEJ) cancer.AMG 199 is a CD3/Muc17 bispecific antibody that can bind CD3-positive T cells to MUC17-positive G/GEJ cancer cells, promote cross-linking of T cells and tumor cells, and induce T cell activation and proliferation.Currently, the drug’s phase I clinical trial (NCT04117958) for gastric cancer or gastroesophageal junction cancer is underway. In June 2020, the FDA granted AMG 199 orphan drug designation.

On September 15, Amgen/BeiGene’s Class 1 new drug AMG 199 was approved for clinical use in China and is intended to treat MUC17-positive gastric cancer or gastroesophageal junction (G/GEJ) cancer. AMG 199 is a CD3/Muc17 bispecific antibody that can bind CD3-positive T cells to MUC17-positive G/GEJ cancer cells, promote cross-linking of T cells and tumor cells, and induce T cell activation and proliferation.

On September 15th, China National Biopharmaceutical Co., Ltd. announced that the diuretic spironolactone tablets (trade name: Livle) developed by the group have been issued by the National Medical Products Administration of the People’s Republic of China to issue a notice of approval for supplementary purchase of drugs, approving the increase of 100mg specification ( It is the first domestically produced specification of this species) and supplementary indications for the treatment of heart failure, hypertension, edema associated with liver cirrhosis or nephrotic syndrome, and primary hyperaldosteronism.

On September 16, Hainan Puli Pharmaceutical Co., Ltd. announced that it had received a notification letter from the US Food and Drug Administration (FDA) that the sodium nitroprusside API has completed a comprehensive scientific review and can fully support the ANDA listing application. Sodium nitroprusside raw materials are mainly used in injections. Among them, sodium nitroprusside injection is a vasodilator, which is mainly used for: immediately lowering the blood pressure of adults and pediatric patients in hypertensive crisis; controlling blood pressure during surgery to reduce bleeding; treatment Acute congestive heart failure.

On September 16th, Gembio released an announcement stating that all three of its testing kits have obtained Class II medical device registration certificates, namely the high-sensitivity cardiac troponin I detection kit (dry immunofluorescence method) and type B natriuresis. Peptide detection kit (dry immunofluorescence method), 25-hydroxyvitamin D detection kit (dry immunofluorescence method).

On September 16, the NMPA official website showed thatTosun PharmaceuticalOlanzapine tablets reported for production under the imitation category 4 were approved and deemed to have been reviewed. Olanzapine is the first atypical antipsychotic approved for the long-term treatment of schizophrenia and the first atypical antipsychotic approved for the treatment of acute bipolar mania.

On September 17, the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China announced that three new class 1 biological drugs under Novartis have obtained clinical trial implied approval, namely TGF-β inhibitor NIS793 and PD-1 Inhibitor PDR001, and monoclonal antibody MBG453 targeting the TIM-3 receptor. According to the CDE official website, the three new drugs have been approved for clinical use in China. The proposed development indications are: MBG453, NIS793 single drug or combined with PDR001 to treat myelofibrosis.

On September 17, CSPC issued an announcement stating that the new drug docetaxel for injection (albumin-binding type) developed by its subsidiary CSPC Zhongqi had been approved by the FDA to conduct clinical trials in the United States. The product uses innovative human albumin coating technology to deliver docetaxel nanoparticles into the patient’s body. With this technology, the product will avoid the pre-administration of docetaxel products currently on the market before injection, reduce injection-related allergic reactions and improve patient compliance. In pre-clinical studies, the product has shown safety and enhanced anti-tumor efficacy against a variety of solid tumors in a variety of animal models.

On September 17, Pfizer PF-06865571 and PF-05221304 two new drugs were approved for clinical trials in China. The indications are: single drug and its combination with PF-05221304 in the treatment of non-alcoholic steatohepatitis confirmed by biopsy ( NASH) Adult patients with stage 2 or stage 3 fibrosis.NASH is a progressive liver disease that is closely related to metabolic disorders such as obesity, insulin resistance, type 2 diabetes and hyperlipidemia. It is the main cause of liver fibrosis, cirrhosis, liver failure, liver cancer and death. Currently, the FDA and EMA have not approved any NASH treatment drugs.

On September 18, Tianjing Biotechnology and MorphoSys of Germany jointly announced that its new drug TJ210/MOR210 for the treatment of relapsed or refractory advanced solid tumors has been approved by the U.S. Food and Drug Administration (FDA) to conduct clinical trials in the United States. Phase 1 clinical trials will begin shortly to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of TJ210/MOR210.

On September 18, Junshi Bio announced that the company’s product, teriprizumab, for the treatment of soft tissue sarcoma, has been certified as an orphan drug by the U.S. Food and Drug Administration. This is the third orphan drug obtained by teriprizumab. Qualification certification. Previously, teriprizumab for the treatment of mucosal melanoma and nasopharyngeal carcinoma has been recognized as an orphan drug by the FDA. As the first domestically produced monoclonal antibody targeting PD-1 approved for marketing in China, Teriprizumab injection has received support from a major national science and technology project.

Performance release

It was learned on September 14 that Qianyuan Pharmaceutical released the 2020 semi-annual report that during the reporting period, the company achieved operating income of 394,615,200 yuan, a year-on-year decrease of 29.28%; net profit attributable to shareholders of listed companies was -75,229,600 yuan, a year-on-year decrease of 278.56% . Regarding the sharp decline in performance, Qianyuan Pharmaceutical explained that during the reporting period, under the significant impact of the new crown epidemic and the withdrawal of important products such as mezlocillin sodium and sulbactam sodium from the National Medical Insurance Catalogue, the company’s sales in the first half of the year fell sharply year-on-year.

Editor: Dun Yuting

36氪Pro is the WeChat public account of 36氪

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