Four Innovative Drugs Approved in China for Hepatitis C, Stroke, Diabetes, and Eczema

Source | Jike Pharma News

On July 30, according to the notice issued by the National Medical Products Administration (NMPA) on drug approvals, four innovative drugs were approved for marketing in China: Ascletis' hepatitis C drug ravidasvir, Simcere's stroke drug edaravone and dexborneol, Merck & Co.'s antidiabetic drug ertugliflozin, and Pfizer's eczema drug crisaborole.

1. New Hepatitis C Drug: Ravidasvir

Ravidasvir is the second Class 1 innovative drug for hepatitis C independently developed by Ascletis. It received support from the National Science and Technology Major Project for "Major New Drug Innovation" during the 13th Five-Year Plan period, and its clinical trial application was included in the priority review program by the National Medical Products Administration (NMPA). In July 2018, Ascletis announced that it had submitted a marketing authorization application for ravidasvir to the Chinese NMPA, in combination with danoprevir, another Class 1 innovative anti-hepatitis C drug developed by Ascletis, as a curative regimen for hepatitis C (the RDV/DNV regimen). Results from Phase II/III clinical trials completed in mainland China showed that after 12 weeks of treatment, the RDV/DNV regimen achieved a cure rate (SVR12) of 99% in patients with genotype 1 non-cirrhotic hepatitis C. Notably, 100% of patients with baseline NS5A resistance-associated substitutions achieved SVR12. It is worth mentioning that ravidasvir has been included in the World Health Organization's guidelines for hepatitis C treatment.

Academician of the Chinese Academy of Engineering and Professor Zhuang Hui from Peking University Health Science Center stated, “Warm congratulations to Ascletis for achieving another major breakthrough in the field of hepatitis C treatment. The clinical study data on the RDV/DNV regimen are highly encouraging. Notably, as China’s first all-oral, interferon-free direct-acting antiviral (DAA) regimen, its efficacy is not affected by baseline NS5A resistance-associated substitutions. This is of great significance for improving the diagnosis and treatment rates among the vast population of hepatitis C patients in China, thereby contributing to the comprehensive control and elimination of hepatitis C in the country.”

2. Edaravone and Dexborneol, a New Drug for Stroke

Edaravone and Dexborneol Injection is an innovative neuroprotective agent that scientifically combines two active ingredients, edaravone and dexborneol, in a 4:1 ratio. By leveraging multiple mechanisms of action—including free radical scavenging, anti-inflammatory effects, and improvement of the blood-brain barrier—it can significantly reduce and ameliorate cerebral neurological damage caused by acute ischemic stroke. According to the Center for Drug Evaluation (CDE) website, the New Drug Application (NDA) for Edaravone and Dexborneol was accepted in November 2018.

A Phase III, randomized, double-blind, active-controlled, head-to-head comparative study involving 1,200 patients with acute ischemic stroke demonstrated that Edaravone and Dexborneol Injection exhibits clear efficacy advantages over Edaravone Injection alone, with comparable clinical safety, and significantly extends the current therapeutic window from 24 hours to 48 hours.

3. Egliflozin, a New Drug for Diabetes

Egletizin Tablets, an SGLT-2 inhibitor co-developed by Merck & Co. and Pfizer, have now been approved, making Egletizin the fourth SGLT-2 inhibitor approved in China, following dapagliflozin, empagliflozin, and canagliflozin.

Ertugliflozin has demonstrated favorable efficacy and safety in clinical trials. Data from two published Phase 3 clinical trials showed that, compared with placebo controls, ertugliflozin significantly reduced glycated hemoglobin (HbA1c) levels in patients, whether used in combination with metformin or with Januvia (sitagliptin). Based on these results, the U.S. FDA approved ertugliflozin (brand name Steglatro) as monotherapy for the treatment of type 2 diabetes in 2019.

4. Crisaborole, a New Drug for Eczema

Crisaborole is a non-steroidal topical PDE4 inhibitor under Pfizer. According to the notice on the issuance of drug approval documents by the National Medical Products Administration (NMPA), Pfizer’s Crisaborole Ointment (Application No.: JXHS2000008) has been approved for marketing to treat atopic dermatitis (eczema). In China, Crisaborole has been included in the “Second Batch of Clinically Urgent Overseas New Drugs” list, with the indication being mild-to-moderate atopic dermatitis in patients aged 2 years and older. The marketing application for this product was accepted by the Center for Drug Evaluation (CDE) on February 10 this year. It was first approved in the United States in December 2016 for the treatment of mild-to-moderate eczema (also known as atopic dermatitis), becoming the first prescription drug for atopic dermatitis to be approved in a decade, as well as the first non-steroidal topical medication that inhibits cutaneous PDE4.

Atopic Dermatitis (AD) is a chronic inflammatory skin disease, commonly referred to as “eczema”—a general term for several types of skin inflammation. Atopic dermatitis is the most common form of eczema and typically begins in childhood, often persisting into adulthood. The pathogenesis of atopic dermatitis results from a combination of genetic, immune, and environmental factors. In atopic dermatitis, the skin develops red, scaly, and crusted raised lesions that are often intensely pruritic; scratching the affected areas can lead to swelling, fissuring, and exudation of clear fluid; ultimately, the patient’s skin becomes lichenified and thickened.

References:

[1] Announcement on Drug Approval Documents Available for Collection, July 30, 2020. Retrieved 2020-07-30, from http://www.nmpa.gov.cn/WS04/CL2455/379027.html

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