Henlius plans for approval of its PD-1 lung cancer drug in China and abroad
Minhua Chu ·01/04/2022

Shanghai Henlius Biotech is beginning to see strong sales from its trastuzumab biosimilar and wants to take its PD-1 drug abroad.

Henlius held the Global R&D Day event in Shanghai on Dec. 17, 2021.

Shanghai Henlius Biotech reported positive phase III data for its PD-1 inhibitor HLX10 (serplulimab) at its Global R&D Day event last month. The company is eyeing NDAs in China and overseas market  for its extensive stage small cell lung cancer (ES-SCLC) treatment.

The interim phase III data from the ASTRUM-005 study showed that serplulimab reduced risk of death by 38% as the first-line therapy for untreated extensive stage small cell lung cancer (ES-SCLC). The median overall survival (OS) was 15.38 months.

The study results showed that serplulimab combined with carboplatin and etoposide prolonged median overall survival (OS) in both the overall population and the Chinese subgroup, with median OS in the overall population of 15.38 months and 11.10 months in the serplulimab and placebo groups, reducing the risk of death by 38% in the overall population (41% in the Chinese subgroup), p < 0.001. The two-year overall survival rate (OSR) in two serplulimab dosing groups was 43.2% and 8.0%, respectively. And the drug also demonstrated a favorable safety profile.

The phase III ASTRUM-005 study was conducted in 128 sites in China, Poland, Russia, Turkey, Ukraine, Georgia and other countries, enrolling 585 subjects, of which approximately 31.5% were Caucasian. On December 7, the Independent Data Monitoring Committee (IDMC) recommended early filing with the results of this pre-defined interim analysis.

NDA for PD-1 antibody in China and overseas market

Based on the ASTRUM-005 study's positive results, Henlius plans to submit a marketing application for ES-SCLC in China and other countries in near future. In non-small cell lung cancer (NSCLC), several clinical trials for first-line treatment are also underway.

Henlius President Jason Zhu

China’s CDE has accepted the market application for MSI-H solid tumor treatment with priority review. The drug's approval is expected in the first half of 2022, making it China's first anti-PD-1 monoclonal antibody for treating MSI-H solid tumors. Henlius President Jason Zhu said that the company would eventually submit the BLA for the indication to global health authorities as well.

Henlius established Hengenix Biotech in California in order to tap the U.S. market.

Over $45 million in sales from trastuzumab biosimilar

There are four marketed products for Henlius now.  All are biosimilars: rituximab, trastuzumab, adalimumab and bevacizumab. Trastuzumab was also launched in the EU under the trade name Zercepac.

Although the biosimilars market in China has been highly competitive, Henlius’ trastuzumab is the only biosimilar in the market. Its sales are therefore growing rapidly since it launched in the third quarter of 2020. It achieved revenues of 287.6 million RMB ($45.2 million) in China and 37.7 million RMB overseas in the first half of 2021, making it the company's top product.

Kurt Yu, Chief Commercial Officer and Vice President of Henlius, said that 63% of the top 1000 hospitals in China had achieved access by the end of this October, and the target is for 70% to achieve access by the end of this year.

However, China is likely to implement national value-based purchasing (VBP) on biosimilars in the near future, with some provinces already starting pilot programs. VBP usually means a significant price reduction in exchange for hospital access, which will put considerable pressure on further sales growth.

Henlius is also expanding the indications of several products it has already launched. The company has submitted an application for Rituximab biosimilar for the treatment of rheumatoid arthritis. This is a new indication for the drug as Rituxan, its reference drug, is not available in China.  

84,000L in three years

Maufacturing capacity is a key factor that has constrained Chinese antibody manufacturers. Disposable bioreactors, most of which have capacities of 2,000L, dominate the production lines.

Henlius Chief Operating Officer and Senior Vice President Wei Huang, shared plans for the construction of a production facility at a recent meeting. The company's production facility in Shanghai's Xuhui District has a capacity of 24,000L. Next year, its Songjiang I facility is expected to expand its capacity to 48,000L.

The company's Songjiang II facility holds promise for a capacity of 36,000L in stage I and the total capacities of the three facilities will reach 84,000L in three years. This puts Henlius capacity high among its competitors. PharmaDJ’s analysis of 2021H1 financial reports indicates that BeiGene has a capacity of 54000L with plans to expand to 64000L, while Innovent Biologics currently has a capacity of 24000L with plans to expand to 60000L. RemeGen intends to expand its capacity to 80,000L by 2025.

Huang Wei said that Henlius’ Xuhui facility has EU GMP certification and the company is preparing for an FDA inspection. And the company boasts China's first GMP-continuous production plant.

12 clincial assets and six awaiting IND

President Jean-Michel Gries and Senior Vice President Xu Wenfeng of Hengenix Biotech introduced the company's early-stage pipelines in the field of oncology immunology.

Among Chinese antibody developers, Henlius is one of the few companies with such rich home-grown pipelines. The company currently has 12 programs in the clinical stage and is preparing to submit IND applications for six assets.

The executives of Henlius answer the questions in the meeting

Henlius has two R&D centers in both Shanghai and California, Gries said. He explained that their R&D are focused on tumors, especially related to lung, breast and gastric cancer. Its other key fields of early research are immune cells and tumor microenvironments.

Xu highlighted the company's two first-in-class early stage programs, HLX301 (PD-L1 xTIGIT bispecific antibody) and HLX35 (EGFR x 4-1BB bispecific antibody). HLX301 was developed based on its TIGIT VHHFc single-domain antibody, while HLX35 has the potential to be first-in-class globally.  The two antibodies already received IND approval in Australia this year. 

Keywords: Henlius PD-1 lung cancer drug approval
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