German pharma Boehringer Ingelheim will be the first company in China to manufacture a biologic, under new regulations aimed at accelerating the launch of innovative new medicines.
The milestone was achieved thanks to Boehringer’s collaboration with Chinese pharma company BeiGene, which included Boehringer offering manufacturing capabilities to support the launch of its monoclonal antibody tislelizumab.
BeiGene’s PD-1 inhibitor tislelizumab was approved in China last week for use in classical Hodgkin’s lymphoma patients who have already received at least two prior lines of treatment.
It is the first drug to be commissioned under the new Marketing Authorization Holder (MAH) system, which falls under China’s revised Drug Administration Law. The MAH system allows drug research institutes and individual researchers to become drug registration applicants.
This means that drug applicants do not have to possess their own manufacturing facilities and can outsource commercial manufacturing to eligible third parties.
“This is an important milestone, not only to ensure the supply of medicines for patients in China, but also for the rapidly emerging Chinese biopharmaceutical research & development landscape,” said John Oyler, chairman and CEO of BeiGene.
“We are very proud to become the first company starting commercial biopharmaceutical manufacturing under the MAH model in China,” said Jiali Luo, general manager and site head of Boehringer Ingelheim Biopharmaceuticals China.
“The newly established model can be of great benefit for the Chinese health care system and provide Chinese patients broader access to more innovative medicine,” he added.
Boehringer will provide the long-term commercial contract manufacturing services for BeiGene’s drug, and will operate as the first company to obtain a MAH in the country.
China has instigated major reforms to its pharmaceutical sector, thanks to a new policy aptly named Made in China 2025 – which aims to accelerate access to innovative new medicines and foster home-grown talent in the industry.
As well as the introduction of the MAH system, the reforms have also introduced changes to the approval process of new drugs, which includes allowing data from trials conducted outside China to be used to gain approval.
The country’s national medicines regulator – the Chinese Food and Drug Administration – was also renamed as the National Medical Products Administrator of China (NMPA).
Boehringer is one of a number of Western pharma companies that have begun to reap the benefits of the new regulations, and will now begin to see the return on its €70m investment in its Shanghai manufacturing facility.