Scrip: industry news and insights
By Kevin Grogan 05 Aug 2021
Just approved In US for chronic kidney disease in patients with type 2 diabetes, Kerendia is going to be an...
On 23 March, after eight weeks of idling, BravoVax finally returned to operations. But the road to recovery has just started for the Wuhan, China-based vaccines developer.
“We had to rely on ourselves for everything, started the reopening by disinfecting all the work areas and it takes even longer for workers to be able to come to work,” said founder and CEO Ke Wu.
Developing a vaccine in China for a private company has not been easy, in a country where state-owned enterprises (SOEs) take the lion’s share of the market and amid the aftermath of scandal after scandal involving vaccine products. Wu said the sudden outbreak of coronavirus in his company's home base greatly disrupted original development plans.
As an industry veteran and overseas returnee, Wu has worked for both large and small biotechs in China, starting as a director of the Wuhan Institute of Biologics of China National Biologics Group under state-owned Sinopharm Group Co. Ltd. and later as an executive vice-president of Zerun Bio, a Shanghai-based vaccine developer. In 2012, he founded BravoVax and chose the Biolake cluster in Wuhan as a base.
Aiming to capture market share in the competitive pneumococcal vaccine sector in China, BravoVax raised CNY300m ($42m) in 2019 to support its R&D efforts. With $6bn in annual global sales, Pfizer Inc.’s Prevenar 13 is the leader and one of the top-selling biologics in the world and BravoVax was looking to its lead asset as a follow-on.
But the coronavirus outbreak, which first emerged in one of Wuhan’s largest markets and quickly forced the government to seal off the city of 11 million people, also forced Wu to reconsider his priorities. To cope, BravoVax has collaborated with GeoVax Labs Inc. in the US and started developing its own recombinant vaccine for SARS-CoV-2 based on a non-replicating viral vector. It has now completed animal testing and plans to file a clinical trial application soon.
“The outbreak has led to R&D uncertainties [for us], forcing us to be more flexible and scratch previous key performance indicators for employees, otherwise we can’t retain talents,” Wu conceded.
Talent aside, state-owned and large companies in China are moving fast and leveraging their size and market dominance to speed ahead in a heated vaccines race, meaning smaller players like BravoVax are struggling to compete.
While some SOEs remained open and worked through the outbreak, encouraged by a government eager to develop the first coronavirus vaccines globally, BravoVax didn’t get a permit to reopen until the end of March, Wu pointed out. The company also had difficulties securing labs and animals necessary for its coronavirus vaccine development.
“The resources for animal testing of vaccines are already limited in China, so are equipment and consumables. State-owned enterprises and large developers have taken them, leaving us no choice but wait,” he said.
Also, it is necessary to get vaccines tested in a P3 (highly biosecure) level lab, but Wu said they couldn’t secure such a facility before all the big players had completed the testing.
If these hurdles mean annoyance and delays for the company, a general sector-wide regulatory requirement for a manufacturing license in the aftermath of a vaccines scandal in China left Wu’s company with its 100 staff in a state of near collapse.
In 2019, one of China’s largest private vaccine developers, Changchun Changsheng Bio, was found to have manipulated expiration dates for its rabies vaccines, setting off a firestorm that shocked the sector.
Once a rising star performer with significant in sales, the Shanghai-listed firm was eventually delisted and declared bankruptcy. Along with the collapse, China’s top regulatory agency head, the commissioner of the National Medical Products Administration (NMPA) Bi Jingqun, was forced to resign over the affair.
In the aftermath, China issued a dedicated Vaccines Administration Regulation, prohibiting contract manufacturing and requiring all manufacturers to have their own manufacturing license for clinical and regulatory filings.
Building in-house production facilities and obtaining the license became not only time-consuming but also costly for a smaller developer like BravoVax. Fortunately, the company found a partner in Jilin Chengda Bio to jointly develop its lead pneumococcal vaccine. Wu said this "felt like a choice between selling one’s own baby or abandoning it."
Even before the Changsheng Bio problems, the sector had been badly wounded by a nationwide scandal in which a mother-daughter team in Shandong province distributed vaccines across the country for years without any cold storage chain, greatly damaging the public trust over such products.
Despite having to refocus R&D priorities from ongoing projects to coronavirus vaccines, Wu also sees some green shoots coming out of the global health crisis.
Facing a time crunch to develop effective and safe new drugs and vaccines to combat the outbreak, several provinces have taken various initiatives to relax rules over manufacturing licenses. Authorities in Sichuan and Jiangsu have said they can issue such a license to coronavirus-related product developers.
Another opportunity is a rolling review system for COVID-19 vaccines, initiated by the NMPA's Center for Drug Evaluation. The fast-track mechanism will substantially shorten the development time frame, which was normally years before the outbreak.
Wu is now actively searching for new funding and fresh investment to leverage the window of opportunity to accelerate BravoVax's SARS-CoV-2 vaccines, which are based on non-replicating and recombinant vectors.
After initially containing the outbreak for two months, China has recently seen a resurgence in infections since mid-June. The fear of a second wave of coronavirus infections is fueling the urgency for the first vaccines to hit the market soon and possibly by year-end. Also, Chinese president Xi Jinping has said that vaccines developed by China will be provided for the “global public good.”
However, out of five vaccines being developed by Chinese companies and in clinical development, four are based on the inactivated virus, a method that is “outdated,” Wu said.
Only one is based on an adeno-associated virus, that being developed by CanSino Biologics and the China Academy of Military Medical Science. Driven largely by political need, a year-end launch for a domestically developed vaccine is highly likely, Wu predicted.
Despite the uneven playing field and regulatory hurdles, Wu maintained there are still advantages for smaller vaccines developers in China, given the huge population and long product life cycle.
The country has the largest newborn population globally following the relaxation of the national one child policy. Amid rising demand for vaccines not included in the national immunization program, requests for human papillomavirus and pneumococcal vaccines are surging.
Many vaccines also have a long life cycle and product gross margins are high, in the 70-95% range, Wu noted, adding that the lack of need for product promotion and market exclusivity mean the sector is going to grow strongly in the years to come.
Several multinationals including Sanofi have recently reported strong quarterly growth for vaccines in China, offsetting the negative impact from volume-based procurement schemes on some of their drug products.
Domestic Chinese vaccine manufacturers are doing so well that a recent high-profile divorce saw the CEO of leading hepatitis B vaccine maker Taikang Bio, Weiming Du, split his assets with his wife. The split value of CNY23.5bn ($3.3bn) was the highest divorce settlement involving any China-listed company.
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