Economic Observer Network reporter Wang Xinning This month, there have been many new news about the research and development of new crown drugs at home and abroad.
On November 16, local time, Pfizer announced that it had applied to the U.S. Food and Drug Administration (FDA) for approval of its Paxlovid pill. Paxlovid is a protease inhibitor that blocks the activity of the protease required for virus replication to achieve treatment. The effect of new coronary pneumonia.
Merck, also a pharmaceutical manufacturer, announced on November 4 that its oral antiviral small molecule drug Molnupiravir has been approved for marketing in the UK. According to public information, Merck and Pfizer both stated that they will sign agreements with generic drug companies to allow multiple countries around the world to produce and sell anti-coronavirus drugs.
After Pfizer announced the latest news about the new drug, Calais (002821.SZ) issued an announcement on the evening of November 16, stating that the company is continuing to provide contract customized research and development (CDMO) for a small molecule chemical innovation drug of a large US pharmaceutical company ) During the service process, its wholly-owned subsidiary Asymchem, Inc. and Jilin Kailaiying Pharmaceutical Chemical Co., Ltd. recently signed a new batch of supply contracts for related products with the customer. As of the signing date of the contract, the cumulative contract value of the CDMO service for this product was US$481 million.
The sales amount of the above-mentioned contracts is approximately RMB 3.07 billion, which is close to Kailai Ying’s 2020 full-year revenue (3.15 billion RMB). Although Kailaiying said that due to the industry confidentiality agreement, it is impossible to disclose customer information and project names, but the market speculates that the contract is a new crown oral drug production contract signed with Pfizer, and the company’s stock price rose 7.03% the next day.
In terms of domestic independent research and development, according to news from CCTV Finance on the 18th, my country has formed a combination therapy of BRII-196 and BRII-198 neutralizing antibodies that block viruses from entering cells, proclulamide, azvudine that inhibits virus replication, and regulates the human body. A batch of key drugs such as the immune system monoclonal antibody BDB-001 injection.
Among them, the neutralizing antibody drugs BRII-196 and BRII-198 were jointly researched and developed by Tsinghua University, Shenzhen Third People’s Hospital and Tengsheng Huachuang. Prokalutamide was developed by Kaifeng Pharmaceutical (09939.HK). According to its latest disclosure, the phase III global multi-center clinical trial of Proklamide for the treatment of hospitalized patients with COVID-19 was completed on October 1 at a clinical center in the United States. Patients were enrolled and administered. The three previous clinical trials conducted in Brazil initially showed that procrulamide can reduce the risk of death in severely ill patients by 78%.
In addition to companies that have made real progress in drug development, many companies are suspected of being hot spots.
On the evening of November 17, Hanyu Pharmaceutical issued an announcement regarding the response to the Shenzhen Stock Exchange’s letter of concern.
Earlier, Hanyu Pharmaceutical issued an announcement on the 14th that it will cooperate with the Institute of Microbiology of the Chinese Academy of Sciences to develop a new coronavirus peptide nasal spray drug. The 6 peptide sequences in the technology are licensed to the company under a global exclusive license, with a total project amount of 65 million yuan. At the same time, the company’s stock price rose 113.31% in 8 trading days from November 5 to November 16.
Since Hanyu Pharmaceuticals suffered three consecutive years of net profit losses during the period from 2018 to 2020, the operating conditions were not good, and the stock price changed significantly before and after the release of good news, which attracted the attention of the Shenzhen Stock Exchange. The Shenzhen Stock Exchange asked it to explain several major issues in the letter of concern. The first is the specific situation of drug development; the second is the company’s financial status and sustainability; the third is to verify the company’s major shareholders and directors, supervisors and senior executives’ trading of the company’s stocks in the past three months 1. The share reduction plan for the next three months indicates whether there is insider trading, market manipulation, etc.
In response to the letter of concern, Hanyu Pharmaceuticals stated that the new peptide drug has completed the design, optimization and screening of the compound, and has not yet begun preclinical research. It needs to go through preclinical research, clinical research, and registration and application phases to be marketed. Whether it will be approved for listing is uncertain.
Hanyu Pharmaceutical’s third quarter report this year showed that the company’s net profit loss from January to September was 118 million yuan, and the balance of book currency funds at the end of the third quarter was 215 million yuan. In the reply, it revealed that the research and development of the new drug project requires a total of 260 million yuan, and the company stated that it will raise funds through multiple channels in the future to ensure the progress of the project.
Judging from the above responses, the new crown new drug project is far from being successfully listed, no matter in terms of project progress or funding preparation.
In addition, the newly listed Tuoxin Pharmaceutical (301089.SZ), which was newly listed on October 27, ushered in a surge in stocks, a letter issued by supervision, and a trading suspension verification within less than a month of listing. The reason is related to Merck’s announcement on November 4 that the new crown drug Molnupiravir will be launched in the UK. Since its listing, Tuoxin Pharmaceutical’s stock has increased by 377.18% within 13 trading days.
Since October 28, investors have been asking Tuoxin Pharmaceutical on the Shenzhen Stock Exchange whether the uridine produced by the company is supplied by Merck’s Molnupiravir new drug. Tuoxin Pharmaceutical’s response is also quite vague, “The company’s product uridine is the raw material for the production of EIDD-2801, and EIDD-2801 is the raw material for the production of the new crown oral drug Molnupiravir.”
The above operations have also attracted the attention of the Shenzhen Stock Exchange. Tuoxin Pharmaceutical started to suspend trading for verification on the 15th of this month, and trading has not resumed as of the 18th.
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