China Business News (Reporter Ma Jia) Following the sale of the old hepatitis B drug Hepudin, the multinational pharmaceutical company GSK (GlaxoSmithKline) recently stopped production of a well-known hepatitis B drug Adefol in the Chinese market Wetyl tablets. It is understood that this drug has been copied and produced by at least 23 domestic generic pharmaceutical companies. In the sixth batch of centralized drug procurement nationwide, two generic versions of this drug won the bid, while GSK's original drug failed to win the bid. In this regard, industry insiders analyzed that the increase in generic drugs leading to shrinking profits of original drugs may be the real reason why the multinational pharmaceutical company stopped producing well-known hepatitis B drugs.
GlaxoSmithKline ceases production of well-known hepatitis B drugs
At the end of April, the Gansu Provincial Public Resource Trading Network issued the "Regulations on Matters Concerning the Cancellation of the Qualifications for Bid-Winning Networks for Applications for Cancellation of Drugs" Notice", among which, GSK's hepatitis B drug adefovir dipivoxil tablets were withdrawn on the grounds of "company suspension of production". It is worth noting that GSK is the only company in the document that applied to withdraw drugs on the grounds of discontinuing production, which also means that GSK’s drug will be withdrawn from the Chinese market. GSK told a reporter from China Business Daily that accelerating the suspension of sales of adefovir dipivoxil tablets is in line with GSK's global strategy of optimizing and simplifying its product portfolio and increasing investment in innovative R&D pipelines and new product R&D.
Adefovir dipivoxil tablets are the main treatment drug for hepatitis B and GSK’s star hepatitis B drug. It was launched in China in 2005. It is worth noting that in the Chinese market, adefovir dipivoxil tablets have been copied by many pharmaceutical companies. According to data from the State Food and Drug Administration, as of 2021, 23 generic pharmaceutical companies in Japan have approved adefovir dipivoxil products.
An imported drug sales agent told a reporter from China Business Daily that the more generic products there are, the smaller the profit margin of the original drug will be. Generic drugs only copy the main molecular structure of the original drugs, with low R&D costs and low prices. Previously, the sales expenses of generic drugs were too high, accounting for a large portion of the operating expenses of domestic pharmaceutical companies. After the implementation of the volume-based purchasing policy, sales expenses have been reduced, and the price advantage of generic drugs has become more obvious, which has created an unfavorable sales situation for higher-priced original drugs.
In the second batch of national centralized drug procurement, generic drug manufacturers Guangshengtang and Qilu Pharmaceuticals successfully won the bid for adefovir dipivoxil tablets at prices of 27 yuan and 28.5 yuan respectively, while GSK failed to win the bid. Currently, many domestic pharmaceutical companies, including Chia Tai Tianqing, Shuanglu Pharmaceutical, Wuzhong Medicine, United Laboratories, Suzhou Erye Pharmaceutical, and Hunan Xiangya Pharmaceutical, are imitating adefovir dipivoxil capsule dosage products.
How is GSK going in the Chinese hepatitis B drug market?
It is worth noting that adefovir dipivoxil tablets are not the first hepatitis B drug that GSK has abandoned in the Chinese market. Previously, GSK sold Hepatin, a mainstream drug for the treatment of hepatitis B, and its production plant to domestic pharmaceutical company Fosun Pharma for 250 million yuan. When Heputin was sold, the official website of the State Food and Drug Administration showed that 16 companies in China had approval for generic drugs of lamivudine, and one of them had passed the generic drug consistency evaluation. In the "4+7" mass procurement, the price of generic drugs produced by Chia Tai Tianqing has been reduced by 90%, which has had an impact on the price of original drugs.
After discontinuing the production of adefovir dipivoxil tablets, GSK may no longer have a flagship product in the Chinese hepatitis B drug market. "Lamivudine tablets (Hepudin) and adefovir dipivoxil tablets used to be GSK's main products in driving revenue in the Chinese hepatitis B market." A person in charge of the sales business of a domestic pharmaceutical company told reporters frankly that at home and abroad As competition for hepatitis B drugs intensifies, GSK may have to develop new drugs to create new performance growth points in this field. In terms of imported hepatitis B drugs, Bristol-Myers Squibb’s entecavir, Novartis’ telbivudine, and Gilead’s tenofovir alafenamide fumarate are all on the market; in terms of domestic hepatitis B drugs, these two GSK There are a large number of generic products for each drug. For GSK, discontinuing production and selling may also release the risk of long-term performance losses.
However, GSK has not given up on the Chinese hepatitis B drug market. GSK said that one of its new drugs with the potential to "functionally cure" chronic hepatitis B is undergoing phase II clinical studies around the world. "This Phase 2a data demonstrates the potential of this new drug to inhibit the hepatitis B virus after four weeks of treatment and marks a potential step towards the company's goal of evaluating a 'functional cure' in patients with chronic hepatitis B .
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Splitting and downsizing of multinational pharmaceutical companies has become a trend
“Selling off original drugs with serious profit shrinkage and deploying innovative drugs has become the profit strategy of many multinational pharmaceutical companies in the Chinese market. "The person in charge of the sales business of the above-mentioned domestic pharmaceutical companies said frankly that after the "4+7" mass procurement, multinational pharmaceutical companies with original research drugs faced the price impact of a large number of generic drugs that passed the consistency evaluation, and had to reorganize their layout in China.
According to incomplete statistics from China Business Daily reporters, in 2021, many multinational pharmaceutical companies such as Pfizer, Merck, Novartis, GSK, and Roche will spin off or sell off their non-core businesses. , or external authorization, or even shut down directly. GSK announced to the outside world that it will focus on supporting the development of vaccines and special drug businesses by divesting non-priority products; Roche also announced to the outside world that it will stop the marketing of mature products such as Rocefen and allocate resources. Focus on innovative drugs; Merck has also divested women's health, biosimilars and some mature drugs. The above-mentioned multinational pharmaceutical companies have made the decision to divest related businesses and focus on innovative drugs after the expiration of their product patents.
After "downsizing", GSK's current business focus may also be on the research and development of innovative drugs. GSK's product pipeline involves respiratory, hepatitis B, central nervous system diseases, AIDS, and vaccines. In recent years, GSK has grown rapidly in China. Innovative drugs in the above fields have been launched one after another, including the bivalent cervical cancer vaccine Cervarix, the asthma and COPD drug fluticasone furoate, and the systemic lupus erythematosus drug belimumab, etc.
"Multinational pharmaceutical companies. 'Downsizing' is due to the impact of performance and having to sell and transfer related businesses to stop losses. For example, after GSK sold off its two hepatitis B drugs, its performance in the field of hepatitis B drugs may be able to "recover" to a certain extent. At the same time, companies also have more capital to gather resources and no longer rely on individual blockbuster products to support revenue. They continue to improve product lines and expand core areas. ” Said the relevant person in charge of the sales business of the above-mentioned domestic pharmaceutical companies.