Source: time Weekly author: Han Liming
The first oral small molecule COVID-19 treatment drug independently developed in China began production.
According to the official account of the municipal government office in Pingdingshan, Henan Province, at 10:00 on August 2nd, the Azvudine tablet production ceremony for COVID-19 's indication was held in Henan Real Biotechnology Co., Ltd. (hereinafter referred to as "Real Biology"), the urban-rural integration demonstration zone of Pingdingshan City, Henan Province.
Real Biology was founded in 2012, focusing on the research, development, production and commercialization of innovative drugs such as antiviral, anti-tumor, cardio-cerebrovascular and liver diseases. It is one of only three companies that have listed innovative anti-AIDS drugs in China.
Azvudine is a leading product of real biology, a new type of nucleoside reverse transcriptase and helper protein VIF inhibitor, and the world's first dual-target anti-AIDS drug. On July 21, 2021, Azvudine tablets were launched as a class 1 innovative drug for the treatment of adult HIV-1 infections with high viral load.
On July 25, 2022, the State Drug Administration conditionally approved the application for registration of COVID-19 indications for additional treatment of Azvudine tablets. Azvudine has become the first approved domestic oral drug COVID-19, and its upstream and downstream industry chain has attracted much attention from the market.
After COVID-19 's indication was approved by Azvudine, on the evening of July 26th, 301089.SZ, an API company, announced that its subsidiary Xinxiang Pharmaceutical has a normal production capacity of 5 tons per year, and will produce it according to market conditions in the future.
According to Henan Radio and Television, Xinxiang Pharmaceutical's new special line for the production of Azvudine APIs was completed and completed in January this year. According to Wang Dedi, general manager of Xinxiang Pharmaceutical, the production line has already produced 650 kilograms of azivudine, and if the follow-up market needs it, the production capacity can be further increased to more than one ton per month.
On March 17 this year, Tuoxin Pharmaceutical Co., Ltd. said in response to a letter of concern from the Shenzhen Stock Exchange that the production capacity, output and sales volume of Xinxiang Pharmaceutical Azvudine API were relatively small, and the revenue realized in the latest period of the year accounted for less than 5% of the company's revenue. In spite of this, under the influence of COVID-19 's concept stock, Tuoxin Pharmaceutical's share price has risen from 19.11 yuan per share to about 105 yuan per share, up more than 449 percent.
On the production side, according to the State Drug Administration, the production unit of Azvudine is Real Biology and Beijing Union Pharmaceutical Co., Ltd. Among them, the real biological products are 3mg, and the raw products of Beijing Union Pharmaceutical Factory are 1mg and 3mg. This also means that real creatures, as developers and listing licensees of Azvudine, can produce Azvudine on their own.
In addition, Real Biology has signed agreements with a number of pharmaceutical companies to entrust the production of Azvudine. On April 26th, Real Biology signed a "Strategic Cooperation Agreement" with 000756.SZ, agreeing that Xinhua Pharmaceutical should be a manufacturer and distributor of its Azvudine and other products in China and other countries agreed by both parties.
In May, Real Biology signed a commission processing framework agreement with China Resources Shuanghe (600062.SH) and Aoxiang Pharmaceutical (603229.SH) to produce Azvudine tablets.
On August 2, the relevant person in charge of Aoxiang Pharmaceutical told time Weekly, "at present, the company has only signed a framework agreement with real biology for Azvudine films, and there is no specific order." The person in charge said he did not know about the production ceremony of Azvudine this morning. Subsequently, time Weekly reporters called China Resources Shuanghe and Xinhua Pharmaceuticals respectively, but the phones were not connected.
On July 25th before Azivudine was officially put into production, Real Biology signed a "Strategic Cooperation Agreement" with Shanghai Fosun Pharmaceutical Industry, a holding subsidiary of Shanghai Fosun Pharmaceutical (600196.SH), to reach strategic cooperation on promoting joint development and the exclusive commercialization of Shanghai Fosun Pharmaceutical Industry (commercialization includes distribution, import, export, sales, promotion, etc.).
In terms of commercialization costs and revenue sharing, in China, the gross profit generated by Azvudine sales is distributed by Shanghai Fosun Pharmaceutical Industries and real creatures according to the proportion of 50%, 50%, 50%, or 55%, according to different sales channels. In the global regions other than China's rights and interests, the specific manner and proportion shall be further agreed upon by both parties in the supplementary agreement.
Public data show that the price of Azvudine tablets as an AIDS drug is 25.86 yuan / mg (tablets). On August 2, time Weekly sent a letter to Real Bio on issues such as Azvudine production capacity and pricing arrangements, which has not been replied to so far.