The facility due to go on stream in late 2022 will complement the German pharmaceutical and agrochemicals group’s existing operations in Beijing, adding more production space and a technical area equipped with automated production lines and logistics.

Bayer plans to use the plant to build up supplies of cardiovascular and diabetes medication, among others, for the Chinese market, where it has produced the drugs since in 1995.

“In the face of huge challenges caused by the Covid-19 pandemic, the initiative fully demonstrates Bayer’s unswerving confidence and commitment to China," Wei Jian, president of Bayer Group China, said in an interview with Shine, part of the Chinese paper Shanghai Daily.

The expansion plans dovetails with a Chinese government effort unveiled in July to implement a "Healthy China 2030" blueprint, designed to improve public health through a range of actions like broader insurance coverage and access to affordable drugs.

Aimed at a swifter and more transparent drug approval process, the Chinese initiative has given rise to an investigative new drug (IND) program with an abbreviated, 60-day trial application process, plus an orphan drug system. It has also allowed ex-Chinese firms to submit foreign clinical trial data, Bayer said.

On Aug. 28, the Leverkusen group announced it had submitted a New Drug Application (NDA) for Chinese approval of the cardiovascular therapeutic vericiguat. The product being developed jointly with US Merck & Co, is an investigational oral, once-daily, first-in-class soluble guanylate cyclase (sGC)-stimulator to treat patients with symptomatic chronic heart failure, some of whom who have had a previous worsening heart failure event.

Early identification and modification of treatment could reduce the risk for heart failure patients, said Bayer’s R&D head, Jörg Moeller. “With approximately 13.7 million patients living with heart failure in China, there is an urgent need for new treatment options to help reduce the burden of this disease.”

The application was submitted to the Center of Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) and was based on what Bayer said was positive Phase III data from the VICTORIA study, Bayer said. Vericiguat has also been submitted for marketing authorization in the EU and Japan as well as multiple other countries worldwide. In addition, the US. Food and Drug Administration granted priority review to Merck`s NDA for vericiguat in July this year.

Author: Dede Williams, Freelance Journalist

Roundup Settlement faces more hurdles

In other news, Bayer's proposal to resolve thousands of US lawsuits claiming the former Monsanto’s Roundup herbicide causes cancer for around $11 billion in total may have hit another snag.  At a hearing last week, US District Court Judge Vince Chhabria, based in San Francisco, California, said he had concerns that the group may have manipulated the settlement process since its original announcements.

Chhabria cited lawyers for some of the plaintiffs who said Bayer had reneged on the deal aimed at resolving 125,000 outstanding cases. The judge said he will revisit the matter on Sept. 24 and decide whether to keep the litigation on hold and allow settlement talks to continue or to let more trials proceed.

If the deal sealed in June were to break down, settlements of many cases would probably still move forward, lawyers representing those plaintiffs told US news media. In April, Bayer had hinted that it might back out of some previously agreed deals for financial reasons, due to the Covid-19 pandemic.