Three Zhongguancun innovative drugs approved

Since this February, three innovative drugs from three biopharmaceutical companies in Zhongguancun have been approved for listing.

The National Medical Products Administration has this year approved the listing of four domestic innovative products. Among them, three are from Zhongguancun enterprises, the highest concentration in the country.

A "fully oral pan-genotype"Hepatitis C therapy covers six populations

In the last month, two drugs of Beijing Kawin Technology Share-Holding Corporation (Kawin Technology) successively obtained production permits.

The two drugs, coblopasvir hydrochloride (Kailiwei) and sofosbuvir (Saibowei), form the first domestic pan-genotype oral therapy for hepatitis C. Coblopasvir hydrochloride is an NS5A inhibitor, which blocks the replication and assembly of the hepatitis C virus by inhibiting the NS5A protein. It is the first domestic pan-genotype anti-viral drug for hepatitis C declared for listing.

Sofosbuvir is a NS5B polymerase inhibitor.

Joint application of sofosbuvir and coblopasvir hydrochloride, can be jointly applied to six populations (genes 1, 2, 3, and 6, liver fibrosis / cirrhosis, patients treated with interferon) and has a sustained virological response of 97 percent, comparable to that of international first-line therapies.

The therapy can reduce the financial burden on patients and simplify the diagnosis and treatment process as there is no need to detect genotype before treatment or to conduct frequent monitoring of liver function during treatment.

The listing of the two drugs breaks the monopoly in China of imported pan-genotype DAA drugs, providing more choices for patients with hepatitis C.

"Bencycloquidium bromide nasal spray"benefits patients with allergic rhinitis

On March 18, bencycloquidium bromide nasal spray (Bilitin), independently developed by Yingu Pharmaceutical Co., Ltd. (Yingu Pharmaceutical), was approved by the National Medical Products Administration. It can relieve runny nose, nasal congestion, itching and sneezing caused by allergic rhinitis.

Bencycloquidium bromide nasal spray is a internationally-leading, highly selective M1 / M3 cholinergic receptor antagonist, which can mediate bronchoconstriction and mucus secretion. Because it can selectively antagonize M1 and M3 receptors without affecting M2 receptors, it has low toxicity and side effects, and can be widely applied.

"Ramulus mori total alkaloid " isthe first new Chinese medicine for diabetes in the past 10 years

On March 18, the innovative Chinese medicine produced by Beijing Wehand-Bio Pharmaceutical Corporation, "Ramulus mori total alkaloid", was approved by the National Medical Products Administration. Its indication is type 2 diabetes. It is the first domestic original natural medicine for reducing blood sugar, and the first new Chinese medicine for diabetes in the past 10 years.

The drug, extracted, separated and purified from ramulus mori, is strongly inhibitory against a-glucosidase and a precise  target range. The Phase II and III clinical trials were led by the Peking Union Medical College Hospital. Using internationally recognized glycosylated hemoglobin, both a randomized double-blind comparative efficacy study compared with the acarbose and a randomized double-blind absolute efficacy study compared with placebo were conducted.

Whether used alone or in combination with metformin, the drug results in a moderate reduction in glycated hemoglobin. Its precise target action significantly reduces adverse reactions, and highlights the safety of natural medicines.