Reporter |
Editor |Xie Xin
4Month27Day`, Gansu Province Public Resources Trading Network`Publish《Notice on Matters Related to the Cancellation of Winning Bid and Listing Qualifications for Drugs Applying for Withdrawal》（Hereinafter referred to as the Notice), recently, 54 companies have submitted applications to withdraw 123 drugs due to reasons such as production line renovations, rising costs, raw material shortages, and discontinuations, making it impossible to ensure the normal supply to medical institutions in our province.
Notification DisplayThis batch includes 123 delisted drugs, of which 107 drugs have alternative products with different specifications available for supply on the platform; 16 drugs have no winning bids on the platform. Among them, GlaxoSmithKline (GSK)'s hepatitis B drug Adefovir Dipivoxil Tablets (Product Name：Hepvirle) Withdrawn on the grounds of enterprise shutdown.This is also the only company in this case to apply for withdrawal due to production halt.。
4Month29Day，GSKIn response to The Paper,GSK decides to accelerate the global discontinuation of Adefovir Dipivoxil sales。ThisIn line with GSK's global strategy to optimize and streamline its product portfolio, and increase investment in innovative R&D pipelines and new product development.
According toAccording to the data from the National Medical Products Administration, GSK's Adefovir Dipivoxil Tablets have only one batch number, H20050651.This indicates, thisGSK's Once-Heavyweight Hepatitis B DrugWillExit the Chinese market.
Adefovir DipivoxilIn2005Launched in China in [Year]，GenusNucleoside analogues，Tablet Fragment、Capsules and Dispersants3Dosage Form，It is a commonly used drug for hepatitis B.2017Year，Adefovir DipivoxilIncluded in the Class B Drug List of the National Medical Insurance through negotiation，2019Annual Renewal Successful。
According to Guosheng Securities, the market size for hepatitis B medications in China is substantial, with a high market concentration, primarily dominated by interferons and antiviral drugs. Currently, chemical drugs in China are mainly divided into two categories: one being interferons, which accounted for about 27% of the market share in 2018. The other category consists of nucleoside antiviral drugs, occupying approximately 37%. By 2020, the market size for hepatitis B treatment drugs in China is expected to reach 20 billion yuan, with a compound annual growth rate exceeding 20%.In addition，Commonly used nucleoside drugs mainlyStillIncluding lamivudine, entecavir, tenofovir disoproxil fumarate, telbivudine, etc.
In fact, Adefovir Dipivoxil is notGSKProducts developed independently, butFromGileadObtained Patent Usage Rights Transfer in HandAccording to this agreement, GSK obtained the exclusive rights to Gilead's first hepatitis B treatment drug, adefovir dipivoxil, covering regions including China, Japan, and South Korea.etc.。
However，In ChinaAdefovir DipivoxilLong since copied by multiple pharmaceutical companies，The叠加of medical insurance cost control and centralized procurement has intensified competition in the anti-hepatitis B drug market.，The profit margin has long been squeezed dry.。According toData from the National Medical Products Administration (NMPA),As of2021Year，In total23China's Generic Drug Companies' Adefovir Dipivoxil Product Approved。
Among them, Adefovir Dipivoxil TabletsTypeIncluded in bulk procurement,In the second batch of China's national drug centralized procurement，Tasly and Qilu Pharmaceutical are the first to pass the consistency evaluation of Adefovir Dipivoxil Tablets.At prices of 27 yuan and 28.5 yuan, respectivelySuccessfully won the bid.At that time, GSK failed to win the bid.
And in Adefovir DipivoxilCapsuleType Aspect，GenericManufacturerStillIncluding Zhengda Tianqing, Shuanglu Pharmaceutical, Wujiang Pharmaceutical, United Laboratories, Suzhou Erye Pharmaceutical, and Hunan Xiangya Pharmaceuticaletc.。
Prior to this, GSK had already sold the related business of its another hepatitis B product, lamivudine tablets, in China. Previously, the product combination of lamivudine + adefovir dipivoxil had been GSK's...InThe leading product in China's hepatitis B market.ButIn July 2019, GSK sold its Suzhou plant and the held hepatitis B drug Lamivudine Tablets to Fosun Pharma.
After abandoning lamivudine and adefovir dipivoxil, GSK has pinned its hopes in the hepatitis B field on a new drug, GSK3228836, which is considered to have the potential for "functional cure" of chronic hepatitis B.Previously, GSK3228836 has achieved positive results in the Phase 2a clinical study for the treatment of chronic hepatitis B. On August 9, 2021, the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced that GSK3228836 injection is proposed to be included in the list of breakthrough therapies.
This time, GSK accelerates the discontinuation of Adefovir Dipivoxil sales.，Like many multinational pharmaceutical companies before，Is currently experiencingDivest products, transfer sales rights, layoffThe epitome of "slimming down" pains。
As the centralized procurement enters deeper waters, the landscape of China's pharmaceutical market is undergoing rapid changes. The advantage multinational pharmaceutical companies once had with off-patent original research drugs is diminishing, and mature products facing competition from domestically produced generics have become the norm. Nowadays, a common choice for multinational pharmaceutical companies is to spin off businesses and sell mature drugs, focusing more on "slimming down" to concentrate their efforts and resources on innovative drug development. There have already been several such cases.
March 2021,Japanese multinational pharmaceutical enterprisesDaiichi Sankyo Plans to Merge Cardiovascular, Anti-Infective, and Respiratory Analgesic Lines Amid Layoffs in Corresponding Product Lines. Previously, Daiichi Sankyo's respiratory analgesic product Loxonin and anti-infective product Cravit had just been included in the fourth round of centralized procurement.
In June 2021, Merck completed the spin-off of Organon, divesting women's health, biosimilars, and some mature drugs.Previously，The patent protection periods for Merck's key products "Singulair" and "Zocor" have expired.