On Jun. 11, 2018, YaoPharma Co., Ltd. (“YaoPharma”) received “Approval Document for Supplementary Application of Drugs” on Alfacalcidol Tablets (“the drug”) issued by the Drug Administration of PRC. The drug has passed the consistency evaluation on generic drugs.

YaoPharma actively engages in consistency evaluation on generic drugs. It has multiple drugs on the review waiting list, and the quantity of consistency evaluation applied is among the most in China.

YaoPharma is dedicated to breaking the pharmaceutical barriers between home and abroad, giving access to overseas patients more drugs made in China, and providing domestic patients with drugs of the same quality as developed countries but more affordability. Alfacalcidol Tablets passed the consistency evaluation on generic drugs, which indicates YaoPharma has reached international standards of R&D system as well as R&D quality control level, leading the domestic market. And proving that YaoPharma has made a firm step into fully improving the quality of generic drugs and therapeutic effects.

ABOUT ALFACALCIDOL

Alfacalcidol is a fundamental drug for the treatment and prevention of Osteoporosis. The group of Osteoporosis patients in China is huge, gradually becoming younger and the market scale of Alfacalcidol is steadily increasing. In 2017, Alfacalcidol formulation recorded sales revenue of over RMB400 million in PRC. Alfacalcidol Tablets（Alfacalcidol Tablets®） produced by YaoPharma is the only and the first drug passed the consistency evaluation on Alfacalcidol oral solid dosage formulation in China. At present, none of the Alfacalcidol oral solid dosage formulation manufacturer, except YaoPharma, applied the consistency evaluation. According to the statistics of IQVIA 2017, the market share of Alfacalcidol Tablets® is nearly 15%. The pass of the consistency evaluation will accelerate the growth of the Alfacalcidol Tablets to a promising future.

ABOUT CONSISTENCY EVALUATION

There were no consistency evaluation requirements for drugs approved in early days in China. There might be some distance between some of the drugs and the innovator’s drug on therapeutic effects. The purpose of consistency evaluation on generic drugs is that generics drugs can be used as substitute for innovator’s drugs, relieve the medical burden of the society, improve the competitiveness of pharmaceutical manufacturers in China, and promote the supply-side structural reform of the pharmaceutical industry.

According to media analysis, due to the high cost of consistency evaluation, the generic pharmaceutical industry will face a major reshuffle, from which two types of pharmaceutical companies may benefit: one is manufacturers have products approved by EU, US or Japan and their domestic products share the same manufacturing line. Another is that manufacturers already have products marketed in EU, US or Japan.

At present, over 95% of the 170,000 drug marketing authorizations in China are generic drugs. As of today, there are 36 drugs of 21 enterprises passed the consistency evaluation.