Shares of new crown drug companies plummeted collectively
The stock prices of new crown oral drug-related companies plummeted collectively on Monday. Domestic pharmaceutical companies, including many manufacturers that were approved to imitate Merck's new crown oral drugs last week, experienced a sharp rise in stock prices on Friday, and their stock prices fell by more than 5% on Monday.
As of midday Monday, Fosun Pharma's Hong Kong (2196.HK) and A-share (600196.SH) shares fell 5% and 7% respectively; Borui Pharmaceutical (688166.SH) fell 8%, Aidi Pharmaceuticals (688488) .SH) shares fell 11%, Essence Pharmaceuticals (002349.SZ) fell 10% and Ascletis Pharmaceuticals (1672.HK) fell 5%.
Via Bio (8173.HK) shares fell 7%.
There are many reasons for the decline in the stock prices of related pharmaceutical companies on Monday.
A number of companies issued announcements after obtaining the authorization of Merck's drug patents, saying that there are no orders for related cooperative drugs, and no production has been started, and the impact of contracts on future performance cannot be estimated.
Investors said that global pharmaceutical companies have recently faced severe market volatility, which is expected to continue throughout the first quarter.
Unclear impact on business performance
In response to the sharp fluctuations in the stock prices of Chinese-related new crown drug manufacturers, Brad Loncar, founder of biological investment fund Loncar Investments, told Yicai.com: "The stock prices of new crown drug-related companies have fluctuated violently recently, and the stock prices of Chinese pharmaceutical companies have Volatility, driven by multiple factors, including recent drug price negotiations and regulatory scrutiny, is likely to subside after the first quarter."
In the U.S. market, shares of biotech companies have fallen nearly 20 percent this year.
Shares of COVID-19 vaccine-related companies BioNTech and Moderna have fallen 43% and 36%, respectively, in the past month.
Last week, Fosun Pharma, Borui Pharma, Longze Pharma, and Desano were licensed to produce both APIs and finished drugs of Merck's new crown oral drug monopiravir, while Viva Bio's Langhua Pharma was licensed to produce Moxa. Nopiravir API.
The drug will not be sold in the Chinese market, although the relevant Chinese company has obtained the authorization to manufacture the drug.
This is because the Medicines Patent Pool Foundation (MPP) only authorizes related companies to use patents in 105 low- and middle-income countries/regions, including India, Pakistan, and Cote d'Ivoire, and these licensed regions do not include China.
According to the announcement of Borui Pharmaceuticals, there are no orders for the cooperative drugs in hand, and no related production has been carried out. The performance of the contract has no significant impact on the company's current performance, and the impact on future performance is still unpredictable.
The company also stated that the production and sales of the cooperative drugs under this license in the region can only be implemented after approval by the relevant competent authorities (including but not limited to marketing approval).
It is uncertain whether the cooperative drugs produced by the company under this license can obtain the marketing approval of the local drug regulatory authorities in the region, and the time to market in the region is uncertain.
In addition, given that the cooperation aims to promote affordable access to monopiravir globally, the price of the product is expected to be lower than the price of the original product or in other middle- and high-income countries, and the specific price and production cost need to be reported MPP, cannot be determined at the moment.
According to the agreement, in addition to the patent license royalties, the product licensing parties do not enjoy the product sales share.
Fosun Pharma also issued an announcement on Sunday emphasizing that under the agreement, the company's new crown treatment oral drug monopiravir will be produced, commercialized and related rights, only include India, Pakistan, Cote d'Ivoire and other lower-income regions, excluding China.
Moreover, the price will be lower. The relevant agreement is not an exclusive license. The group has no orders for the cooperative drug, and has not yet started related production.
The Group also stated that it is still uncertain whether the cooperative drug will be approved by local drug regulatory authorities in the region, or the timing of the drug’s launch, but it is expected that the price of the drug will be lower than that in middle- and high-income countries under this sub-license, and When the new crown epidemic is no longer classified as a "public health emergency of international concern" by the WHO, royalties will be paid at 5% or 10% of annual net sales.
behind the license
Ma Dawei, an academician of the Chinese Academy of Sciences and the Shanghai Institute of Organic Chemistry of the Chinese Academy of Sciences, told Yicai.com that the cost of new drug research and development is very high. In contrast, the production cost of chemical drugs is negligible, and the US market obtains high profits through high-priced sales. to recover costs.
A person from a Chinese company authorized to manufacture MSD's new crown drug told Yicai.com: "For companies, obtaining authorization is generally a good thing, but it is more about social responsibility than profit. "
According to a statement issued by Dr Reddy's, an Indian generic drug company, the company will produce Merck's new crown oral drug monopiravir, which costs only about 47 cents per pill, and the total price of a course of 40 drugs is less than 20 dollars.
In the United States, the price of a course of Merck's new crown oral medicine is about $700.
一位长期从事制药行业知识产权研究的业内人士对第一财经记者表示：“对于企业而言，生产新冠仿制药可能确实赚不了钱，竞争也很激烈，但是仿制药企业之所以仍然会选择签署自愿许可协议，一方面是出于人道主义的考虑，另一方面企业一定是想盈利的，也是希望借此换取一些政府订单。”
去年11月，辉瑞与也与MPP签署新冠抗病毒口服候选药物Paxlovid许可协议，以扩大在中低收入国家的可及性。根据辉瑞公司发布的公告，为增加中低收入群体获得新冠药物的机会，将通过自愿许可协议，使合格的许可证持有者能够获得生产仿制药的资格，从而向95个国家/地区提供新冠口服药与利托那韦药物联用组合，这些国家/地区约占全球总人口的53%。
目前新冠仍然被世界卫生组织列为国际关注的突发公共卫生事件，根据协议，辉瑞将不会向中低收入国家收取特许权使用费。
不过目前中国企业尚未通过MPP获得Paxlovid的生产许可。根据临床试验数据，辉瑞的新冠口服药Paxlovid在预防重症和死亡方面的有效性接近90%，高于默沙东的莫诺匹拉韦。Paxlovid在全球的供应仍然紧张，即便在美国的很多药店也严重缺货。
美国FDA于去年12月批准了辉瑞的Paxlovid新冠口服药，但截至目前美国仅提供了16万个疗程，药物供不应求。
上周，辉瑞已经宣布，未来5年将投资5.2亿欧元，在法国增加其新冠口服药的生产设施，以实现2022年在全球生产1.2亿个疗程新冠口服药的目标。