Weekly Asia Highlights- China and Japan

Ascletis’ First Dual-DAA Regimen for HCV Bags China Approval

On July 31, 2020, Ascletis Pharma Inc. in China announced that its dual-drug, all-oral HCV treatment had got the marketing approval in China. The medication is Ravidasvir in combination with Danoprevir.

In phase II/III clinical trial, RDV/ DNV Regimen demonstrated a cure rate of 99 % after a treatment of 12 weeks in genotype 1 patients, and even a cure rate of 100% in patients with NS5A resistance mutations.

Ravidasvir is a next-generation, best-in-class, and pan-genotypic HCV NS5A inhibitor with a high genetic barrier to resistance, while Danoprevir is the first direct-acting agent (DAA) developed by Ascletis and approved in China in 2018. The RDV/DNV Regimen is the first all-oral interferon-free HCV regimen developed by a China-based company.

The epidemic of hepatitis C has been a massive problem in China. Even the latest antiviral agents for HCV can cure over 90% of cases. There are still many patients in China who can’t afford medication due to the high cost of foreign patent drugs. Therefore, this approval of all-oral, interferon-free HCV medication would probably accelerate the approach to cure HCV in China.

Teva submits NDA for Fremanezumab in Japan

On July 29, 2020, Teva Pharmaceutical announced Otsuka Pharmaceutical had applied the PMDA of Japan to obtain manufacturing and marketing approval in Japan for Fremanezumab injection for the preventive treatment of migraine.

Fremanezumab is an anti-CGRP (calcitonin gene-related peptide) monoclonal antibody approved by the US in 2018 and EU in 2019. It is currently the first and only long-acting anti-CGRP subcutaneous injection that can be administered every three months.

As part of a May 2017 exclusive license agreement for development and sales of Fremanezumab in Japan, Teva and Otsuka announced outcomes from two Phase 2/3 clinical trials of Fremanezumab in patients with episodic and chronic migraine in Japan at the beginning of this year. The primary and secondary endpoints were achieved in both trials with statistical significance, which means Fremanezumab had significant improvements versus placebo in the treatment. Additionally, Fremanezumab was well tolerated with a similar adverse events profile compared to the placebo.

Teva’s Alteration of Strategic Focus in the Japanese Market

The next day, July 30, 2020, Teva announced a new strategy for its commercial operations in Japan. The company’s Japan Business Venture with Takeda Pharmaceuticals will mainly focus on commercializing generic drugs, specialty assets, and pipeline opportunities.

This joint venture will be expected to combine Teva’s expertise in marketing, commerce, and medical care, with Takeda’s leading brand reputation and strong distribution network in Japan to realize its medical vision and meet the needs of more patients.

First China-mAb Biosimilar for Breast Cancer Gets EU Approval

July 29, 2020, The European Commission (EC) has approved Zercepac, a trastuzumab biosimilar developed by Shanghai Henlius Biotech, and set to be marketed by Accord Healthcare, for the treatment of breast cancer. The indications include HER2-positive early breast cancer, HER2-positive metastatic breast cancer, and HER2-positive metastatic gastric cancer.

Zercepac is the first China-developed mAb biosimilar successfully launched on the EU market. Meanwhile, its facility has become China’s first EU certified GMP site to manufacture a self-developed antibody biosimilar.

Japan Approves Dexamethasone as Second-Line COVID-19 Treatment

On July 22, 2020, the health ministry of Japan approved dexamethasone, a common and inexpensive steroid, as second-line therapy of COVID-19 based on a clinical trial in the UK dexamethasone has shown a significant reduction of mortality rates in severe cases. This is the second approval for a Covid-19 treatment in Japan, following the remdesivir’s authorization in May.

Dexamethasone has received global attention since last month, Based on the positive outcomes of RECOVERY trial performed by the University of Oxford, it has been authorized for COVID-19 in the UK in June 2020. The trial compared 2,104 patients administered with dexamethasone for 10 days to 4,321 patients who were not, and the result demonstrated that the risk of death was reduced by 35% in COVID-19 patients on ventilation and 20% in patients on oxygen only.

References

1. https://www.ascletis.com/news_detail/172/id/386.html
2. https://www.henlius.com/en/NewsDetails-2670-26.html
3. https://www.tevapharm.com/news-and-media/latest-news/teva-announces-new-drug-application-filing-in-japan-for-ajovy-fremanezumab-injection/
4. https://www.reuters.com/article/us-health-coronavirus-japan-dexamethason/japan-approves-dexamethasone-as-coronavirus-treatment-idUSKCN24M34M

By Vicky Su
Editor: Sherry Hsiao

Author

Sherry Hsiao