Oseltamivir is Gone, and the Pattern of Anti-influenza Drugs is Reversed!

The latest weekly influenza report of the National Influenza Center on June 17 (6.6-6.12) showed that the proportion of influenza-like cases (ILI%) among outpatient cases reported by sentinel hospitals in southern provinces was 5.8%, higher than the previous week's level (5.1%). It is higher than the level of the same period in 2019-2021 (4.4%, 3.0% and 4.3%), and significantly higher than the proportion of influenza-like illness (ILI%) in outpatient cases during the same period of the influenza outbreak season in 2019. According to the latest data from the World Health Organization's Global Influenza Surveillance and Response System, the incidence of influenza in the northern and southern hemispheres has rebounded significantly since 2022. Since June, Fujian, Guangdong, Hainan, Jiangxi and other places have issued emergency warnings one after another. The number of fever clinics admitted to some medical institutions has increased, and many places in the south have entered the peak of influenza in summer.

Oseltamivir is no more

Due to the high incidence of influenza, the antiviral drug oseltamivir, which can be used for the treatment and prevention of influenza A and B, has become a "hard currency". Many people regard it as a "magic drug", resulting in a shortage of stocks or shortages in some hospitals and pharmacies. . The reporter visited some pharmacies in Guangzhou and found that oseltamivir had been sold out. Mainstream e-commerce platforms such as Jingdong Pharmacy and Dingdang Kuaiyao also showed that they were out of stock and replenished. A relevant person in charge of a pharmacy told reporters, "At present, the drug is mainly supplied to hospitals, and the pharmacy is unable to stock it, and it is unknown when it will arrive."

Affected by the epidemic, the public's awareness of protection has increased, the spread of influenza has decreased, the flow of people in hospitals has dropped significantly, and the sales of anti-influenza drugs represented by oseltamivir have dropped significantly. Some analysts pointed out that with the recovery of influenza virus prevalence, it is expected that sales of anti-influenza drugs are expected to bottom out in 2022. At the same time, oseltamivir has been included in the seventh batch of centralized procurement, and the market structure will usher in a reshuffle.

At present, the anti-influenza drugs on the domestic market are mainly oseltamivir, and the original research product is Roche's "Tamiflu". In 2006, Roche authorized the production of oseltamivir to Shanghai Zhongxi Pharmaceutical Co., Ltd. and Sunshine Pharmaceutical Co., Ltd., and marketed it under the trade names of Orfi and Kewei. Relying on the advantages of unique granule formulation, optimized production process, self-supplied APIs and a fully self-operated promotion team, Kewei has become the largest seller of oseltamivir in China since 2013. According to the data from Minet.com, Sunshine Pharmaceutical is the dominant company, occupying nearly 90% of the domestic market share, Roche is 9.89%, and Shanghai Zhongxi Pharmaceutical is only 1.04%. In 2019, Kewei's sales exceeded 5.93 billion yuan.

However, Sunshine Medicine, which once relied on "Kewei" to make a lot of money, is no longer the same as it used to be. In 2020, the new crown pneumonia epidemic is popular. With the public's increased awareness of protection, wearing masks, and reducing social gatherings, the number of cases in the 2020-2021 flu season has dropped significantly, and the global flu drug sales have experienced a cliff-like decline. In 2021, sales of Roche's Tamiflu will drop by nearly 80%, and sales of Sunshine's Kewei will also drop significantly. In 2020 and 2021, Kewei's sales continued to decline sharply, with sales of 2.069 billion yuan in 2020 and only 555 million yuan in 2021, a year-on-year decrease of 73.19%.

It is understood that after the sharp drop in sales, HEC Pharma also changed its sales model, canceling the direct sales teams in some provinces, and the province's general agent for products. Dai Wenjie, Marketing Director of Wankang Health Investment told reporters, "Affected by the new crown epidemic, anti-viral and anti-infective drugs are rarely sold. Although some places have lifted the ban, the management of drug use is very strict. Many retail pharmacies and terminal clinics are prescribing such drugs. Due to restrictions and regulatory inspections, they will be taken off the shelves if they are unwilling to sell. Commercial companies also try not to take these products as much as possible, because they are worried that they cannot be sold and the drugs will expire, so they are unwilling to press the products. Although there is market demand, the enthusiasm of channel dealers is not high, so The market for these products is not very mobile.”

The changing landscape of anti-influenza drugs

In addition to the epidemic factor, the "Kewei" of HEC is also facing the pressure of competition from many companies and the pressure of centralized procurement to reduce prices. At present, oseltamivir products that have been marketed in China include capsules, granules, and dry suspensions.

In the past two years, domestic oseltamivir phosphate capsules have ushered in the market blowout period, and 10 domestic pharmaceutical companies have been approved; oseltamivir phosphate granules are still the exclusive product of HEC; dry suspensions have 2 The company has a production approval, and Chengdu Bite Pharmaceutical won the first imitation. In addition, more than 10 companies including Pioneer Pharmaceuticals, Yangzijiang Pharmaceutical Group, and Chongqing Shenghuaxi Pharmaceutical have submitted their listing applications for Oseltamivir Phosphate Capsules under review and approval. For oseltamivir phosphate dry suspension, more than 10 companies including Shijiazhuang No. 4 Pharmaceuticals, Lepu Pharmaceuticals, Qilu Pharmaceuticals, etc. have submitted marketing applications for review and approval, and the competition is fierce.

In the seventh batch of centralized drug catalogues published on June 20, oseltamivir oral normal-release dosage forms (capsules) are listed impressively, and there are as many as 11 companies that meet the application qualifications. After the centralized procurement, the market structure of oseltamivir will usher in changes.

However, some industry analysts believe that "the threat of oseltamivir generic drugs to 'Kewei' is limited. First, 'Kewei' has formed a brand effect in the market; second, the capsules are for adults." The sales volume of Kewei' is mainly driven by children's granules. With the rise of influenza, it is expected that the performance of HEC Pharmaceuticals will reverse."

It is worth noting that, as a research hotspot in the field of medicine, more and more companies are involved in the research and development of new anti-influenza virus drugs. In recent years, new anti-influenza drugs have emerged. In April 2021, Roche's innovative influenza drug mabaloxavir was approved for marketing for the treatment of acute uncomplicated influenza patients 12 years of age and older, including those at high risk of influenza complications. In the same year, the drug was successfully included in the medical insurance. The retail price before the medical insurance negotiation was 498 yuan per box, and the price after the medical insurance negotiation was 222.36 yuan per box, about 111 yuan per tablet. Another drug Rongyun data shows that the current domestic companies in the development of new influenza drugs include: Zhongsheng Ruichuang ZSP1273 tablets and granules, Zhenbaodao Pharmaceutical/Guangzhou Hengnuokang Pharmaceutical's HNC042 for injection, Qingfeng Pharmaceutical/Ginkgo's GP681, Taijing Pharmaceutical R&D (Beijing) Co., Ltd. endonuclease inhibitor TG-1000, Zhengxiang Pharmaceutical’s new anti-influenza drug ZX-7101A, Antikang Bio’s ADC189, and China Pharmaceutical University’s new class 1 antiviral drug baicalein (derived from natural medicines) )Wait.

Under the pressure of market changes and competition from latecomers, Sunshine Pharmaceuticals also actively rescued itself. On the one hand, HEC Pharmaceuticals has gradually expanded its presence in oseltamivir. In addition to capsules and granules, dry suspensions are also about to be approved. The submitted clinical application for oseltamivir phosphate sustained-release tablet 2.2 new drugs is in the process of being approved. Under review and approval. On the other hand, in August last year, HEC decided to sell the shares of HEC Pharmaceuticals to Guangdong HEC Pharmaceutical Co., Ltd. However, the aforementioned industry insiders believe that "with the launch of new anti-influenza drugs, the competition on the track will intensify, which will inevitably compress the overall market space of oseltamivir. Although HEC has taken measures to actively respond, it is still unknown whether the business performance will improve. ."