Henlius Manufacturing Plant Gains European Stamp of Approval

For a company with global ambitions for a trastuzumab biosimilar candidate, it’s important to meet international standards for manufacturing and quality control, and Henlius Biotech of Shanghai, China, said a successful EU inspection of its Xuhui Facility has provided that level of certification.

Henlius has multinational agreements to market the biosimilar HLX02, which is currently awaiting authorization for marketing from the European Medicines Agency. That application was filed in June 2019.

The company is poised to put its commercialization plans for HLX02 into high gear. “Henlius has reached strategic cooperation agreements with Accord, Cipla, Mabxience, and Jacobson Medical for the commercialization of HLX02 in over 80 countries and regions around the world,” the company said.

Exclusive Rights for Sales of HLX02

Accord has been granted exclusive rights to sell HLX02 in Europe, the Middle East, North Africa, and the Commonwealth of Independent States (Eurasian post-Soviet Union states).

It was, in fact, Accord’s marketing application for HLX02 that was filed with the EMA last June. Henlius said HLX02 has the potential to become the first biosimilar developed in China to be approved in the European Union.

In a release, the company said its Xuhui Facility has received EU Good Manufacturing Practice (GMP) approvals, based on on-site inspection, which certify that it complies with manufacturing standards.

It’s a huge and important milestone, the company said, because the EU GMP stamp of approval represents “one of the most authoritative and rigorous inspections globally.”

The EU GMP inspection is recognized by nearly 30 EU member states and the inspection results also may be shared with other countries that have signed Mutual Recognition Agreements with the European Union. These countries include the United States and Canada.

“Therefore, the EU GMP Certificate is considered a passport for drugs to be launched in international markets and has significant global impact,” Henlius said in the statement.

Product Meets End Point

HLX02 is a biosimilar developed and manufactured by Henlius for the treatment of HER2-positive early-stage breast cancer, HER2-positive metastatic breast cancer, and HER2-positive metastatic gastric cancer.

In a November presentation at the European Society for Medical Oncology Asia Congress 2019, the company reported that the biosimilar met its primary end point of best overall response rate at week 24 in a phase 3 trial of the drug in patients with breast cancer.

Henlius was founded in 2010 and has established 3 research and development facilities in Shanghai, Taipei, and California. The company is focused on developing biologics for oncology and autoimmune diseases.

In February 2019, the company's first product, HLX01, a rituximab injectable biosimilar, was approved by the China National Medical Products Administration (NMPA) and became the first biosimilar launched in China.

Henlius said a new drug application for HLX02 filed with the NMPA has been assigned to the priority review list and the agent is expected to be launched in China this year.

“We will make every effort to accelerate the global commercialization progress of HLX02, hoping to benefit more patients and to represent China in the 'World Cup' to compete with the world's top bio-pharmaceutical companies from Europe, the United States, South Korea,” and other regions, Scott Liu, cofounder and chief executive of Henlius, said.