On January 21, the news that five Chinese pharmaceutical enterprises were allowed to produce and imitate MSD covid-19 oral medicine for free detonated the stock prices of relevant stocks. Brightgene Bio-Medical Technology Co.Ltd(688166) 20cm limit, Jiangsu Aidea Pharmaceutical Co.Ltd(688488) rose more than 10%, and Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) rose 5.98%; Hong Kong stocks rose more than 13%.
5 Chinese pharmaceutical enterprises are authorized
On January 20, the drug patent pool (MPP), a non-profit organization supported by the United Nations, announced that it had signed contracts with 27 generic drug suppliers around the world, authorizing them to supply molnupiravir, an anti covid-19 small molecule therapeutic drug of methadone for 105 low-income countries.
According to the official website of MPP, qualified suppliers in China include Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) , Brightgene Bio-Medical Technology Co.Ltd(688166) , Langhua pharmaceutical, Desano, Longze pharmaceutical, etc. Among them, Langhua pharmaceutical is only authorized to supply APIs, and other Chinese companies are also authorized to produce APIs and preparations. Tianyancha shows that the listed company Jiangsu Aidea Pharmaceutical Co.Ltd(688488) holds 4.76% equity of Longze pharmaceutical.
In terms of business model, MPP itself does not produce API or generic drugs. Who (World Health Organization) and MPP jointly screen drugs from the perspectives of disease burden, effectiveness and accessibility. After the patent holder cooperates and authorizes, the global API / generic drug supplier shall fill in EOL (letter of intent), The original manufacturer can choose whether to charge franchise fees (for example, as long as covid-19 pneumonia is still regarded as a public health emergency of international concern by who, MSD will not charge licensing fees for molnupiravir). The authorized pharmaceutical enterprises need to promote sales in the authorized countries.
According to the MPP official website, the capacity reserve, high-quality production capacity, R & D capacity, regulatory completeness and financial status contained in EOL are important criteria for MPP assessment.
How long can go on sale after being authorized?
Relevant people of Longze pharmaceutical said that this is only a patent authorization, not equal to approval. Drugs are highly regulated industries, and there is still a long way to go before they are listed.
"After getting the authorization, it takes time to register in the corresponding countries before the drugs are put on the market." The source said.
The person said that the company's products are planned to be sold in familiar markets such as South Africa, Brazil and Russia; In addition, Pakistan and Southeast Asia will also consider development in the future. Because the products are listed, they need to be registered in the corresponding countries. Because the regulations on drug listing are different in various countries, the time of listing is also inconsistent. Some countries may soon, especially countries with serious epidemic situations may have green channels.
Before submitting the listing application, the company also needs to make a series of pre listing preparations. The relevant person of Longze pharmaceutical said: "the company's raw material technology package has been available, and the prescription process of the preparation is relatively simple, but after it is completed, the corresponding stability test should be done normally, and the application should be submitted after collecting the data. Under normal circumstances, even if our R & D is faster, it will take 8-10 months."
How does affect related companies?
Relevant people of Longze pharmaceutical said that at present, India already has the guidance price of relevant products, and the daily treatment cost is about $18. "Generally speaking, each country is more like a bidding market, and the initial profit will be greater."
The source said that there are so many generic drug companies approved this time. The price of the first listed company may be high, and the last listed company should be the lowest price. In his opinion, the pricing of products listed at the beginning will be a market behavior.
Brightgene Bio-Medical Technology Co.Ltd(688166) today's announcement indicates that this license is a non exclusive license, and the licensed areas are 105 low-income countries / regions such as India, Pakistan and C ô te d'Ivoire, excluding China. The pricing of the product is expected to be lower than that of the original research product or in other middle and high-income countries. The specific price and production cost cannot be determined temporarily, and the impact on future performance cannot be predicted.
Zheshang Securities Co.Ltd(601878) believes that obtaining MPP authorization is an embodiment of a company's global compliance production capacity. Benefiting from the supporting advantages of China's chemical industry and the accelerated expansion of compliance capacity, it is expected that China's API and cdmo (customized R & D and production) companies will deepen their influence in the global drug supply chain. From the perspective of internationalization of APIs and preparations, the sales volume of the company after authorization depends on the international sales network construction and supply chain management ability of each company.
