The recent approval of AstraZeneca/Merck’s Lynparza reflects the accelerating pace of Chinese drug approvals under the country’s new policy regime, according to data and analytics company, GlobalData.
China medicine
Lynparza, a poly (ADP-ribose) polymerase (PARP) inhibitor, is the first of its kind to be approved in China for the treatment of platinum-sensitive recurrent ovarian cancer. Additionally, it is the first overseas drug to be sanctioned under China’s new priority review policy on the basis of international multicentre data.
Although PARP inhibitors have been mainstays in the US and Europe to treat ovarian and breast cancer since 2015, China has remained an untapped market. Epidemiologists from GlobalData have estimated that there were 33,075 diagnosed incident cases of ovarian cancer in urban China in 2017, of which 4,201 possess germline BRCA1 or BRCA2 mutations, for which PARP-inhibitors would be of use.
As the incidences of these cases is expected to increase to over 46,000 by 2027, a need to address the issue has become imperative.
In light of this, a set of policies was announced by Chinese officials in October 2017, which include acceptance of clinical data that had been collected overseas for imported drugs for rare or life-threatening diseases, such as cancer. Lynparza’s approval is an indicator that the Chinese regulators are fulfilling their promise to accelerate availability of these vital medicines.
Paul Jeng, pharma analyst at GlobalData, stated: “AstraZeneca’s win raises the pressure on other developers, including domestic firms such as Jiangsu Hengrui Medicine and BeiGene, which are focused on the Chinese market.”
Recently, however, BeiGene launched an IPO on the Hong Kong exchange, and is reportedly in the process of developing the investigational PARP inhibitor pamiparib for gastric and ovarian cancer. Tesaro has also initiated a small, pivotal Phase III trial in China investigating Zejula as first-line maintenance for platinum-sensitive ovarian cancer. Its plans, along with its partners at Zai Lab, is to combine the results of the domestic clinical trial with those from foreign trials to submit for regulatory approval, which is hoped to be achieved by 2020.
“For now, the short-term successes of China’s regulatory reforms are a preview for how the next years may play out in China’s healthcare market,” concluded Jeng. “In particular, the activity around PARP inhibitors indicates that accelerated approvals will be likely driven by areas of high unmet need in oncology and other therapeutic spaces.”