How does "medical headline jun" new drug development get better? 2019 CDE chemical drug review report
Release date: 2020-01-07 Views: 0
(2020/01/06) Anesthesia triopoly "Onslaught" large variety of injections! Four Class 1 new drugs launched in the tens of billions of markets; Novan's antiviral drug SB206, two Phase III clinical failures, stock prices plummeted 74%; inventory of logic and implementation paths for medical policies in 2019; domestic biosimilars expected to be approved in 2020 ... (Click the title for the original text)
Novan抗病毒药物SB206两项三期临床失败股价暴跌74% [Medicine Time 1] Two Phase III clinical failures of Novan antiviral drug SB206 plunge 74%
Recently, Novan announced that its antiviral drug SB206 failed to beat placebo in two Phase 3 clinical trials (B-SIMPLE1, B-SIMPLE2) for the treatment of molluscum contagiosum. The Black Swan incident directly caused Novan's market value to shrink by 74%.
黑天鹅反复无常。 Head bacteria: Black Swan is capricious.
In 2019, drug development is still one of the important topics related to national economy and people's livelihood in China. Consistency evaluation work has been fruitful. "4 + 7" has brought about a lot of purchases, and the medical insurance negotiation has demonstrated the country's efforts on the availability of drugs.
2019年是政策落地大年。 Head bacteria: 2019 is the year of policy landing.
On January 6, Credith announced the completion of 280 million yuan in financing of its diagnostic business segment. This round of financing was led by China Resources Pharmaceutical Industry Investment Fund, jointly led by Lu Xin Venture Capital and Shandong Transportation Industry Development Fund, Shanghai Zhangjiang Technology Venture Capital Co., Ltd., Xinzhongli, Guangzhou Qudao Asset, Guangzhou Guofa Venture Capital, and others The fund participates in investment together.
老股东再次追加投资。 Head bacteria: old shareholders add additional investment.
2019 is the first full year of performance after the institutional reform. The three departments have made great efforts: the National Health and Health Commission issued a total of 161 policies and regulations, the National Medical Insurance Bureau issued a total of 26 heavy policy documents, and the National Drug Administration 61 regulatory documents were issued.
速览2019年医疗政策的整体逻辑。 Head bacteria: a quick glance at the overall logic of health policy in 2019.
The PharmaGo database of PharmaGo shows that in addition to the four companies approved above, there are currently many domestic companies with multiple biosimilar drugs that have already been declared for marketing or are in phase III clinical stage, and some of them are expected to be approved in 2020.
有你感兴趣吗？ Papilloma: Are you interested?
武汉肺炎已排除SARS但病原仍未明确香港疑似病例增至16宗 [Eight o'clock health news] SARS has been ruled out in Wuhan with pneumonia, but the pathogen has not been identified. The number of suspected cases in Hong Kong has increased to 16
The "unknown cause of pneumonia" epidemic in Wuhan continues to attract attention. It is still unclear what the pathogen is. The Wuhan Health and Medical Commission issued a third notice on the evening of January 5 stating that it had ruled out influenza, bird flu, adenovirus, severe acute respiratory syndrome (SARS) and the Middle East respiratory syndrome (MERS).
相信我国医疗水平。 Head bacteria: Believe in China's medical level.
Judging from the data of the first three quarters of 2019, the competition pattern in the TOP10 list of the world's best-selling drugs is constantly changing. Only the three major cities of Merlot, Ruifumei, and Kyao are still intact.
非常有趣的竞争格局。 Head bacteria: a very interesting competitive landscape.
The discussion about cost and value at one time became more complicated and even more commercial. The enthusiastic expectations of innovation from all walks of life, the impact of centralized procurement pricing, payers, patient rights groups, and regulators are challenging the front-runners of the pharmaceutical industry, asking the pharmaceutical industry to prove both the initial data related to the population and protect the value To make it last longer.
这是企业需要考虑的问题。 Papilloma: This is something that companies need to consider.
Hengrui exclusively selected 2 over-assessed varieties. In addition, 10 varieties (7 of which are TOP10 varieties) have been evaluated for consistency in corporate layout. Due to high barriers to R & D, production and sales of anesthetics, the domestic drug market is concentrated. Enhua is a leading company in this segment. Who is the better of the three?
恒瑞率先突围。 Head bacteria: Hengrui took the lead.
Multinational pharmaceutical companies in 2019 released three quarterly reports one after another. The Chinese market data is “surprising”: Merck's 90% growth has made other multinational pharmaceutical companies “unmatched”; Roche's mainland China and Hong Kong markets, 53% growth in the first nine months Lilly's sales in the Chinese market increased 33% year-on-year in the third quarter; AstraZeneca's revenue in the first three quarters of China increased 37% year-on-year.
谁是当下中国医改政策下的最大赢家？ Head bacteria: Who is the biggest winner under China's current medical reform policy?
- Basic introduction of Heilongjiang Hexiang Pharmaceutical Co., Ltd.
- How to contact Bermuda Medical (Shanghai) Regenerative Medicine Technology Co., Ltd.
- Shandong Dongfang Huiyi Health Industry Co., Ltd.
- Brief introduction of Zaozhuang Yinhai Pharmaceutical Co., Ltd.
- Contact information of Shandong Dongfang Huiyi Health Industry Co., Ltd.
- Introduction of Bermoudi (Shanghai) Regenerative Medicine Technology Co., Ltd.
- 开始了！ 1. It's started! 6 illegal actions at designated drug stores
- 有望中美申报上市！ 2. China and the United States are expected to apply for listing! Yifan Pharmaceutical's Class 1 new drug F-627 Phase III clinical success in China
- 『医药头条君』新药研发如何越来越好？ 3. How is the research and development of new drugs in "Medical Headlines" getting better and better? 2019 CDE chemical drug review report
- 2019年全球十大热门生物技术盘点 4. Inventory of the world's top ten hot biotech in 2019
- 重磅！ 5. Heavy! Domestic application for the fourth indication of O drug
- 2019 CDE年度药审报告：589个化药1类申请1045个ANDA 6. 2019 CDE annual drug review report: 589 chemical drugs, Class 1 applications, 1045 ANDA
- 达格列净上市申请获FDA优先审查 7. Dagle's net listing application receives FDA priority review