Daehwa Pharm applies for approval of anti-dementia patch in China

South Korea's Daehwa Pharm Co. is speeding up its advance into the Chinese market for anti-dementia medicine, applying for sales approval of its patch using the brain function-improving agent rivastigmine through a joint venture there.

The company on Thursday said its Chinese joint venture JHK Biopharma recently completed an application for generic approval of Daehwa's patch with China's National Medical Products Administration.

The application was for two types of products: one measuring 4.6 milligrams that lasts 24 hours and the other 9.5 mg.

The Shanghai-based JHK, in which Daehwa holds a 25% stake, releases commercial products using Daehwa's transdermal drug delivery system and oral dissolving film technologies.

"This is the first application for a domestically made rivastigmine patch for approval in China," a Daehwa source said. "We expected to receive the OK by 2025."

As of last year, China had over 10 million people with Alzheimer's, or 25.5% of the world's total. By 2050, the country is forecast to have over 40 million such patients.

Rivastigmine, which is used to treat Alzheimer's and Parkinson's, used through a patch can also relieve dysphagia, or the condition of difficulty swallowing food. A Daehwa source predicted a favorable response from the Chinese market since the patch is an external solution with nothing to spit out.

In its candidate patch in China, the company also used specific additives to reduce skin irritation and excluded crosslinking agents. It added an outer adhesive layer to prevent the active ingredient from escaping through the patch's edge.

The company in recent years has aggressively advanced into the Chinese market. In September 2017, it exported its potable Liporaxel technology for treating a variety of cancers to Haihe Biopharma and in September last year, it applied for a new drug application for treatment of gastric cancer.

In June 2018, Daehwa signed a single-supply contract worth 100 billion won for the dermal filler Amalian with Shenzhen Zhijun Pharmaceutical, a subsidiary of China National Pharmaceutical Group Corp., aka Sinopharm. The filler's application for approval was completed in April this year.

Write to Ji-Hyun Lee at bluesky@hankyung.com