Nuggets innovative medicine is jointly launched by the daily economic news and Yaodu data. It aims to interpret the progress and trend of new drug research and development, analyze product competitiveness and market prospects, gain insight into the context of pharmaceutical capital, and witness the high-quality development of the pharmaceutical industry.
According to the data of Yaodu, from May 5 to May 15, 2022, the drug evaluation center (CDE) of the State Drug Administration received 39 applications for new chemical drugs and therapeutic biological products submitted by 17 listed companies.
New drug application
From May 5 to May 15, 2022, the period from May 5 to May 15, 2022, the year of May 5 in 2022, the year of May 5, the year of May 5 to May 15, the period of listed companies, the Jiangsu Hengrui Medicine Co.Ltd(600276) . Sh (6 Jinfa Labi Maternity & Baby Articles Co.Ltd(002762) 76. SH) reports 11 clinical applications for the Chengdu Kanghong Pharmaceutical Group Co.Ltd(002773) . SH), Hunan Jingfeng Pharmaceutical Co.Ltd(000908) ( Hunan Jingfeng Pharmaceutical Co.Ltd(000908) . SZ), Zhejiang Medicine Co.Ltd(600216) ( Zhejiang Medicine Co.Ltd(600216) . SH), Sichuan Kelun Pharmaceutical Co.Ltd(002422) ( Sichuan Kelun Pharmaceutical Co.Ltd(002422) . SZ) Lepu bio-b (02157. HK), Jiangsu Sinopep-Allsino Biopharmaceutical Co.Ltd(688076) ( Jiangsu Sinopep-Allsino Biopharmaceutical Co.Ltd(688076) . SH), Shanghai Junshi Biosciences Co.Ltd(688180) (01877. HK), connaught-b (02162. HK), Liaoning Chengda Biotechnology Co.Ltd(688739) ( Liaoning Chengda Biotechnology Co.Ltd(688739) . SH) and stone Pharmaceutical Group (01093. HK) apply for one clinical application respectively; Hansen Pharmaceutical (03692. HK) applied for 3 production applications and Beijing Tiantan Biological Products Corporation Limited(600161) ( Beijing Tiantan Biological Products Corporation Limited(600161) . SH) applied for 1 production application.
New drug hot review
1, Jiangsu Hengrui Medicine Co.Ltd(600276) pd-1 international phase III clinical data released, countdown to sail
On May 12, Jiangsu Hengrui Medicine Co.Ltd(600276) disclosed the latest results of the international multicenter phase III clinical trial of PD-1 monoclonal antibody (carrelizumab) combined with apatinib mesylate tablets independently developed by Jiangsu Hengrui Medicine Co.Ltd(600276) in the announcement. According to the judgment of the independent data monitoring committee (IDMC), the main endpoint results of the clinical trial meet the pre-set excellence standard of the protocol.
A total of 543 subjects were randomly enrolled in the clinical trial according to 1:1. They were treated with carrelizumab (200mg, once every two weeks) combined with apatinib (250mg, once a day) or sorafenib (400mg, twice a day).
It is worth noting that the phase III clinical study of carrelizumab was conducted by Qin Shukui of the tumor center of Nanjing Jinling Hospital, with the participation of 95 centers in 13 countries and regions. It is also the first international multicenter phase III clinical study carried out by Jiangsu Hengrui Medicine Co.Ltd(600276) .
The results showed that carrelizumab combined with apatinib and sorafenib, as a first-line treatment, could significantly prolong the progression free survival (PFS) and overall survival (OS) of patients with advanced hepatocellular carcinoma.
At present, the application for marketing license of carrelizumab combined with apatinib for first-line treatment of unresectable or metastatic hepatocellular carcinoma patients who have not received systematic treatment in the past has been accepted by China's State Drug Administration, Jiangsu Hengrui Medicine Co.Ltd(600276) said that it plans to submit the communication application for new drug marketing to FDA in the near future.
industry insight:
Jiangsu Hengrui Medicine Co.Ltd(600276) announcement shows that at present, 8 indications have been approved among the five major tumor species of lung cancer, liver cancer, esophageal cancer, nasopharyngeal carcinoma and lymphoma, and it is listed as the PD-1 monoclonal antibody with the most approved indications in China together with the tirelizumab of Baiji.
In addition to the two, five anti-PD-1 monoclonal antibodies have been approved for listing in China, namely Shanghai Junshi Biosciences Co.Ltd(688180) of treprizumab, cindilimab of Cinda biology, paianprizumab of Zhengda Tianqing and kangfang biology, sepalizumab of Yuheng biology and sloulimab of Fuhong Hanlin.
In foreign countries, four PD-1 monoclonal antibodies have been approved for listing, including pabolizumab of MSD, nabulizumab of Bristol Myers Squibb, cemiplimab of regenerative yuan pharmaceutical and dostarlimab of GlaxoSmithKline. Both pabolizumab and nabulizumab have been approved for listing in China.
At present, the consensus view in the industry is that under the background of white hot competition in the Chinese market, it is the general trend for each PD-1 to go to sea. Cinda biology, Shanghai Junshi Biosciences Co.Ltd(688180) , Baiji Shenzhou and kangfang biology have submitted new drug marketing applications to FDA. From the progress of going to sea, Jiangsu Hengrui Medicine Co.Ltd(600276) of carrelizumab has lagged behind its competitors.
However, on the whole, the road to sea of domestic PD-1 is not smooth. In February this year, Cinda bio's cindilimab was required by FDA to supplement additional clinical trials to prove the applicability of its products in the U.S. population because it failed to achieve "differentiation"; On May 4, Shanghai Junshi Biosciences Co.Ltd(688180) announced that FDA required a change in the quality control process Shanghai Junshi Biosciences Co.Ltd(688180) plans to meet directly with FDA and is expected to resubmit the biological product license application for treprizumab before midsummer 2022.
company comments:
From the annual report of Jiangsu Hengrui Medicine Co.Ltd(600276) , the intention of the company to reduce cost and increase efficiency, continue R & D investment and accelerate going to sea is obvious. According to the data, the company invested 6.203 billion yuan in R & D in 2021. Among them, overseas R & D investment totaled 1.236 billion yuan, accounting for 19.93% of the total R & D investment.
According to the statistics of Sinolink Securities Co.Ltd(600109) Research Report, Jiangsu Hengrui Medicine Co.Ltd(600276) has established R & D centers in China, the United States, Europe, Australia and Japan, with more than 5400 R & D teams, including more than 170 overseas R & D teams. At present, the company has carried out nearly 20 international clinical trials, including 7 International multi center phase III projects, and more than 10 studies are in the preparation stage.
The researcher of nuggets innovative medicine believes that although the FDA application of domestic PD-1 has been frustrated one after another, it may not be a bad thing for Jiangsu Hengrui Medicine Co.Ltd(600276) which is slightly behind the progress of going to sea. If carrelizumab can implement the principle of "differentiated innovation", it may be able to overtake on the way to sea. At the same time, with the advancement of internationalization, the sales revenue in overseas markets is expected to become a new growth point of Jiangsu Hengrui Medicine Co.Ltd(600276) performance.
2, Shanghai Junshi Biosciences Co.Ltd(688180) vv116 is the first company to release the clinical research results of Omicron. What is the impact of the Shanghai epidemic
On May 18, the official wechat of "Huashan infection" released the first clinical study data of Shanghai Junshi Biosciences Co.Ltd(688180) anti covid-19 virus small molecule oral drug vv116 in Chinese Omicron infected subjects.
The data showed that the nucleic acid negative time of patients infected with Omicron using vv116 within 5 days after the first positive nucleic acid test was 8.56 days, which was less than 11.13 days in the control group. In symptomatic patients, vv116 given within the medication time range of this study (2 ~ 10 days after the first nucleic acid positive) can shorten the nucleic acid negative time of patients. In terms of drug safety, no serious adverse reactions were observed in patients who used vv116.
However, the article also points out that as an open and prospective cohort study, the sample size included in this study is limited, and all subjects have not developed severe or critical illness. Therefore, this study failed to collect enough data to further analyze whether vv116 has a preventive effect on the severe infection of Omicron, and only preliminarily evaluated the single index of nucleic acid negative conversion in mild patients.
In early May, at a press conference held in Uzbekistan, the price of vv116 was disclosed for the first time. Its price in Uzbekistan was 185 US dollars per treatment course, equivalent to about 1234 yuan.
industry insight:
At present, the only domestic covid-19 therapeutic drug approved is the neutralizing antibody therapy of tengshengbo drug-b (02137. HK). In terms of research and development progress, up to now, there are only three domestic covid-19 oral drugs that have entered the phase III clinical research stage, namely azvudine of real organism, Shanghai Junshi Biosciences Co.Ltd(688180) vv116 of and prochloramide of developing pharmaceutical industry; In addition, Geli pharmaceutical, Xiansheng pharmaceutical, Yunding Xinyao and other pharmaceutical enterprises also have layout, but they are all in the approved clinical or preclinical stageP align = "center" Image Source: screenshot of Research Report
At present, a number of covid-19 therapeutic drugs have been approved in the U.S. and European markets worldwide, including small molecule oral drugs, neutralizing antibodies and other different types of therapeutic drugs. Pfizer paxlovid and mosadon molnupiravir have achieved relatively clear curative effects and are widely used all over the world.
Guotai Junan Securities Co.Ltd(601211) released the research report that covid-19 treatment system is constructed by "small molecule chemical drugs + neutralizing antibodies", and the use of neutralizing antibodies abroad is large. Small molecule oral drugs may become the main force in the treatment of mild and moderate patients.
Recently, the research and development progress and cooperation dynamics constantly spread in the field of covid-19 specific drugs have been "eye-catching" in the capital market. Domestic covid-19 oral drugs have made a sprint to be officially wholesale. Investors in the market have also begun to bet, and from drug R & D enterprises to upstream raw material suppliers have become the object of speculation.
In late April, Shandong Xinhua Pharmaceutical Company Limited(000756) ( Shandong Xinhua Pharmaceutical Company Limited(000756) . SZ) announced that it had signed a strategic cooperation agreement with real creatures. Real life agrees that Shandong Xinhua Pharmaceutical Company Limited(000756) is the manufacturer and distributor of azvudine and other products in China and other countries agreed by both parties. Subsequently, Shandong Xinhua Pharmaceutical Company Limited(000756) share price rose for 11 consecutive trading days. On May 8, China Resources Double-Crane Pharmaceutical Co.Ltd(600062) also announced the signing of the strategic cooperation agreement and the framework agreement on the entrusted processing and production of azvudine tablets with real organisms China Resources Double-Crane Pharmaceutical Co.Ltd(600062) will make full use of the advantages of equipment and production conditions to provide a good product production environment for Shandong Xinhua Pharmaceutical Company Limited(000756) and promote the transformation and implementation of real biotechnology achievementsP align = "center" Image Source: Announcement screenshot
On May 19, Zhejiang Hisun Pharmaceutical Co.Ltd(600267) ( Zhejiang Hisun Pharmaceutical Co.Ltd(600267) . SH) announced that the company and Shanghai Wangshi Biomedical Technology Co., Ltd. signed the strategic cooperation agreement and the entrusted production framework agreement. The two sides intend to establish a strategic cooperation relationship in the fields of product processing, production, international registration and market development of small molecule innovative drug vv116. The agreement is valid for 5 years.
company comments:
Just when the market talked about that azvudine, a real organism, might become the first domestic covid-19 oral drug approved, Shanghai Junshi Biosciences Co.Ltd(688180) 's vv116 made a number of research and development and commercialization progress, adding many variables to the final "who will spend" of the first domestic covid-19 oral drug.
For the investors of Shanghai Junshi Biosciences Co.Ltd(688180) , a common concern is whether the research and development progress of vv116 and the production of treprizumab will be disturbed by the Shanghai epidemic. In this regard, the reporter of the daily economic news learned from the Shanghai Junshi Biosciences Co.Ltd(688180) aspect that the company's port production base arranged some employees to stay on the site for closed-loop management before the start of the epidemic prevention sealing and control policy, and dynamically adjusted the production rhythm to maintain the uninterrupted operation and maintenance of the equipment. At the same time, Shanghai Junshi Biosciences Co.Ltd(688180) also actively coordinates the company's R & D and production resources outside Shanghai to ensure the normal promotion of research projects and ensure the continuous supply of commercialization and clinical drugs.
