Pharma News

2021-10-28: The introduction of the new drug administration law at the end of 2019 announced that China's drug regulation has entered a new era. In the new regulatory environment and market environment, China's pharmaceutical industry has entered a period of rapid iteration and industrial chain reconstruction. The competitive relationship between the key links of the pharmaceutical industry chain is undergoing profound changes, prompting drug research and development institutions, researchers and drug manufacturers to face new challenges and opportunities. The drug marketing license holder system (MAH) is one of the core contents in the new drug law system. In March 2020, the State Administration for Market Regulation issued the "Measures for the Administration of Drug Registration" (Order No. 27 of… [Read more]
2021-10-28: [Pharmaceutical Network Market Analysis] Recently, Fosun Pharmaceutical issued an announcement stating that in order to enrich the pipeline of vaccine products, on the basis of existing viral vaccine products, it will expand the reserve of bacterial vaccine products. Intends to cash and held by the Dalian ally feng 100% equity pricing holding acquisition ant gold in the total amount of more than 4 billion yuan. For such a large investment, the industry believes that it is because the vaccine industry market is very impressive. It is understood that in China, due to the huge population base of our country, with the increase of people's disposable income and the increasing awareness of vaccination, China's vaccine market is maintaining a rapid growth trend, the overall market size is also… [Read more]
2021-10-28: [Pharmaceutical Network Enterprise News] Vaccine is currently recognized as one of the effective methods to prevent infectious diseases. In recent years, with the advancement of medical technology and the continuous improvement of people's health awareness, the scale of the vaccine market is constantly rising. The data show that China's vaccine market size in 2016, to 2019, has dropped from 24 billion yuan to 42.5 billion yuan. According to the current development trend, the industry predicts that with the continuous enrichment of vaccine varieties and the continuous improvement of accessibility, as well as the increase in per capita income and the increasing awareness of vaccination, the future of China's vaccine market will continue to maintain rapid growth, the 2021, or will grow to… [Read more]
2021-10-28: [Pharmaceutical Network Industry News] Hainan Province has issued 14 "Drug Production License" (B Certificate) since September 30, 2020, and issued a total of 14 "Drug Production License" (B Certificate). It is reported that at present, there are 13 drug varieties in Hainan Province from other provinces to Hainan (some enterprises are going through the declaration and transfer of the number of procedures), accounting for Hainan 2021 new drug varieties of 1/5. The industry said that these enterprises will cultivate a new force for the Hainan pharmaceutical industry and inject new vitality into the development of the pharmaceutical industry. It is understood that previously, drug research and development institutions without drug production capacity could not directly obtain drug approval… [Read more]
2021-10-28: Recently, some companies have said that they have made new progress in the process of internationalization. For example, on October 26, Lunan Pharmaceuticals received a letter of approval from the US FDA on rosuvastatin calcium tablets ANDA (a brief application for new drugs) to increase the production site of Shandong New Era Pharmaceutical, it marks that the ANDA rosuvastatin calcium tablets produced by Lunan Pharmaceuticals can be sold in the United States. The company said that this is of great significance in the internationalization process of Lunan Pharmaceutical. Data show that rosuvastatin calcium tablets are a selective Hydroxymethylglutaryl coenzyme A reductase inhibitor, which has the characteristics of powerful lowering blood lipids and is fast and safe. Hengrui… [Read more]
2021-10-28: [Pharmaceutical Network Market Analysis] Recently, three quarterly reports of listed companies in the pharmaceutical equipment industry, including Chutian Technology, East Fulong, Xinlai Yingcai, and Canaan Technology, have been intensively released. Among them, the former three companies 1 Sep of net profit to achieve a certain growth, the overall performance for the better. Most of the company's net profit growth is related to the prosperity of the biopharmaceutical industry. For example, Chutian technology in the reporting period, new orders increased by 98% compared with the same period last year, it is reported that in the first three quarters of pharmaceutical equipment sector revenue and orders have accounted for about 40 percent of the company's share; xinlai Ying Cai previously… [Read more]
2021-10-28: [Pharmaceutical network industry dynamic] License introduction (License in) is a kind of product introduction mode, different from the self research products or direct acquisition company, License in mode, product introduction can only introduce one product from the product licensee according to its own standards. Since the beginning of this year, License in trading in the pharmaceutical industry continues to be hot, a large number of pharmaceutical companies are through the License-in model, to enrich the product pipeline, as well as accelerate innovation. Such as recently, Luo Xin pharmaceutical subsidiary Shandong Luo Xin with the Austrian Marinomed Biotech AG company (hereinafter referred to as "Marinomed") signed a "license agreement", on the introduction of Budesolv®(Budesonide… [Read more]
2021-10-28: Purified water equipment can prepare high-standard purified water for biopharmaceuticals, medical equipment and other industries to meet the demand for high-quality water quality in the production process. The continuous and stable operation of the system depends not only on the high-performance process technology of the equipment, but also on the correct operation and maintenance of the user. Although the purified water equipment is already fully automatic operation, it is very important for equipment management personnel to fully understand the equipment water production process and operation and maintenance, it is the basis for using purified water equipment to avoid failures as much as possible, and to ensure more stable and safe operation after the equipment is put into use. Over… [Read more]
2021-10-28: 2021 years and 10 months 22nd China innovative RNA drugs R & D enterprises Shenzhen New Biomedical Science and Technology Limited Company (hereinafter referred to as the new biological) with South Korea's leading technology companies MDimune Inc. (hereinafter referred to as the MDimune) announced the signing of an agreement on cooperation in mRNA tumor treatment drugs and cutting-edge delivery technologies. Both parties will adopt novel therapeutic targets and MDimune proprietary novel exosomes (CDV)-based BioDrone®Platform technology for multi-indication exploration. Based on the protocol, the new and MDimune will jointly explore opportunities to use exosomes to deliver mRNA vaccines to treat neoplastic diseases. After the initial success, the two sides will promote further commercial… [Read more]
2021-10-28: On October 26, 2021, the strategic signing and listing ceremony of "Microspectrum & Sanquan Zhongshi CCIT Joint Laboratory" was solemnly held at the Baoshan R & D Center of Microspectrum Biomedicine. This is the microspectrum and Brucker, Sciex, Agilent, Thermo Fisher respectively since the establishment of a joint laboratory strategic cooperation, is also the first time in the field of microspectrum biomedicine with domestic instrument suppliers to establish a joint laboratory, it means that the strategic cooperation between the two sides has been upgraded again. The establishment of the CCIT joint laboratory aims to combine the deep cultivation of microspectrum in the field of pharmaceutical equipment research and development, and the innate advantages of Sanquan Zhongshi in packaging… [Read more]
2021-10-28: Zejing Pharmaceutical recently received the "Notice of Acceptance of Clinical Trials" approved by the State Drug Administration, the Company's independent research and development of ZG19018 tablets for the treatment of advanced solid tumors with KRAS G12C mutations in the application for clinical trials to be accepted. ZG19018 is a selective covalent inhibitor of KRAS G12C, which belongs to Class 1 small molecule anti-tumor drugs and is expected to be used for the treatment of KRAS G12C mutation tumor. At present, only one similar mechanism drug has been approved for marketing worldwide. Amjin's KRAS G12C covalent inhibitor Sotorasib(AMG510) was accelerated in May 2021 for the treatment of non-small cell lung cancer (NSCLC) carrying the KRAS G12C mutation. ZG19018 can bind to the… [Read more]
2021-10-28: On October 27th, Li's big pharmaceutical factory announced that its Zhaoke Cancer Drug Co., Ltd. submitted the anti-PD-L1 monoclonal antibody Shouke injection (Socazolimab) of the new drug listing application has been accepted by the State Food and Drug Administration, used to treat recurrent or metastatic cervical cancer. Priority review and conditional approval applications have also been submitted with the new drug application. Socazolimab is the domestic fifth paragraph of the listing of the PD-L1, but also the first domestic declaration for the second line of cervical cancer PD-1/PD-L1. Socazolimab as a whole human anti-PD-L1 monoclonal antibody against a tumor PD-L1 protein, the immune system caused by the tumor cells can be released. Clinical studies of monotherapy for… [Read more]
2021-10-28: October 27 Yunnan Baiyao release three of the quarterly bulletin, the first three quarters of the company revenue in 28.363 billion yuan, a year-on-year growth of 18.52%; Implement net profit of 2.451 billion billion yuan, a year-on-year decline of 42.38%. The third quarter net profit of 0.649 billion billion yuan, a year-on-year decline of 63.94%. The company said that the current confirm share-based payment and 0.866 billion yuan in the prior-period NONE. Strike out the part of the costs of the impact, achieving attributable to shareholders of the listed company of non-recurring gains and losses of net profit of 3.667 billion billion yuan, an increase of 15.14% over the same period. The report shows that Yunnan Baiyao in the first three quarters of the total R & D expenditure to 0.196… [Read more]
2021-10-28: On October 26, Fosun Pharmaceutical issued an announcement stating that in order to enrich the pipeline of vaccine products, it will expand the reserve of bacterial vaccine products on the basis of existing viral vaccine products. Intends to cash and held by the Dalian ally feng 100% equity pricing holding acquisition ant gold in the total amount of more than 4 billion yuan. Dalian Yalifeng is a viral vaccine research and development production enterprise, Antejin is a bacterial vaccine research and development and production enterprise, after the completion of the acquisition, Fosun Pharma will hold about 73.01% of the equity, and through Antejin holds a stake in Dalian Yalifeng. At present, the 13-valent pneumococcal conjugate vaccine (PCV13) under development by Antekin is in phase… [Read more]
2021-10-28: October 28, 2021, San Francisco, USA and Suzhou, China-Cinda Biopharmaceutical Group (Hong Kong Stock Exchange Stock Code: 01801)("Cinda Bio"), a company dedicated to R & D, production and sales for the treatment of cancer, biopharmaceutical company of innovative drugs for major diseases such as metabolic diseases and autoimmunity, and Shenzhen Xinhe Biomedical Technology Co., Ltd. ("Xinhe Bio"), A biotechnology company dedicated to building the world's leading AI-enabled RNA innovative drugs, jointly announced a strategic cooperation between the two parties, carry out a clinical study on the combination of cidilizumab injection and the new biologic personalized new antigen vaccine neoantigen vaccine NEO_PLIN2101. According to the cooperation agreement, Cinda Bio will establish a… [Read more]
2021-10-28: [Pharmaceutical Network Product Information] On October 26th, Lunan Pharmaceutical received a letter of approval from the US FDA on rosuvastatin calcium tablets ANDA (a brief application for new drugs) to increase the production site of Shandong New Era Pharmaceutical Co, this means that it will help to improve the production capacity of rosuvastatin calcium tablets, ensure continuous and stable market supply, further meet the demand of the US market and accelerate the rush to the US market, and to provide protection for the patient's drug accessibility. At the same time, it also proves that its product quality meets the requirements of the United States for drugs and cGMP, highlighting the company's strong innovation capabilities and scientific research strength. Rosuvastatin calcium… [Read more]
2021-10-28: [Pharmaceutical network industry news] since the beginning of this year, the pharmaceutical industry departure tide has been in the industry for only October fen cutoff 22, there are 25 pharmaceutical executive positions changed, involving 23 pharmaceutical companies. Among them, 18 pharmaceutical companies have executives resigned. It is reported that these executives involve positions such as chairman, president, and general manager. The reasons for separation mainly include personal reasons and job changes. For example, the human resources department of Baekje Shenzhou announced to employees that the national head of blood tumor sales will leave the company on November 15, 2021 to seek external development opportunities. Currently successor has not yet been determined, temporarily by… [Read more]
2021-10-28: [Pharmaceutical Network Industry Dynamics] The development of innovative drugs and innovative therapies is a long-term and high-risk work, which will be affected by many factors. Under the traditional Me-too model, it seems that people rarely see failed projects. However, in recent years, with the process of accelerating the development of innovative drugs by more and more pharmaceutical companies, the number of new drug research and development failures and terminations has also begun to increase. For example, recently, a number of large multinational pharmaceutical companies have announced the termination of new drug development projects. Recently, Lilly disclosed an important news in the third quarter financial report. October this year, the company and its partner Pfizer terminated… [Read more]
2021-10-28: [Pharmaceutical Network Product Information] Drug clinical trials refer to any systematic study of drugs conducted in the human body (patients or healthy volunteers) to confirm or discover the clinical, pharmacological and/or other pharmacodynamic effects, adverse reactions and/or absorption, distribution, metabolism, and excretion to determine the safety and effectiveness of the test drug. Drug clinical trials are generally divided into Phase I, II, III, and IV clinical trials, drug bioequivalence tests and human bioavailability, which are essential steps to confirm the effectiveness and safety of new drugs. Since October this year, Hengrui Pharmaceutical, Baekje Shenzhou, Sansheng Guojian and other enterprises have submitted clinical applications for independently developed new drugs,… [Read more]
2021-10-28: [Pharmaceutical Network Policies and Regulations] The biomedical industry is a strategic emerging industry that own country focuses on. In order to accelerate the high-quality development of the biomedical industry, in recent years, from the national level to the local level of good policies continue to be introduced. Among them, in terms of encouraging the research and development of new drugs, since the beginning of this year, many places have launched a policy "red envelope rain". According to the Hunan province issued by the Ministry of bio-pharmaceutical industry innovation and development of several opinions which states that investment of more than 50 million million yuan to the innovative medicines each variety to no more than 5 million yuan subsidy; the patents of three out of… [Read more]

Last updated: 2021-10-29 05:51:10 Beijing Time

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