Shanghai Henlius Biotech Maps Out Its Biosimilars Future

Shanghai Henlius Biotech is one of many companies in China working to crack open the market there to biosimilar competition. However, Henlius stands out so far for some notable achievements, such as bringing the first biosimilar (rituximab) to market in China and achieving significantly rapid market penetration in the product's first several months of life.

The company has bigger ambitions to achieve dominance not only in China but also on the world biosimilar stage, Ping Cao, company vice president of business development, explained at the recent Festival of Biologics USA meeting.

Henlius was formed in 2010 and filed its first biosimilar investigational new drug application (HLX01, rituximab) with the Chinese National Medical Products Administration (NMPA) in 2011. The company opened its first Good Manufacturing Practices–certified factory in 2016, and HLX01 was approved in China in 2019, becoming the first biosimilar approved in China.

In July 2020, the company saw its trastuzumab biosimilar (HLX02, Zercepac) approved in the European Union. The same drug was approved a month later in China, and in December of 2020, Henlius succeeded in getting an adalimumab biosimilar (HLX03) approved in China, also.

The company decided that its first several biosimilars would be oncology products because of the relatively huge market for oncology treatment in China. That meant the company saw huge potential in rituximab, trastuzumab, and bevacizumab biosimilars. The company anticipates an FDA filing for its bevacizumab biosimilar (HLX04) in 2021.

It also anticipated strong growth for its adalimumab biosimilar, referencing the blockbuster Humira, which Cao said still has a relatively small share of the market for autoimmune diseases in China. “Autoimmune disease actually has a huge unmet need in China,” she said. Humira’s 2019 sales share in China vs its global penetration rate was 0.2%, and the estimated access rate (to adalimumab) in China in 2020 was 1.3% of patients vs a potential market of 6.7 million patients.

Global marketing of its biosimilars is an important element of the company’s growth strategy , but Henlius also wants to develop biobetters, drugs that are based on originator products but deliver better efficacy, improved safety, or other enhancements. Developing new biologics and combination therapies also is a targeted area for growth at Henlius, Cao said.

Its second wave of biosimilar contenders may target the cetuximab (Erbitux, rectal and head and neck cancer), ramucirumab (Cyramza, solid tumors), pertuzumab (Perjeta, breast cancer), and denosumab (Prolia/Xgeva, bone loss) markets. Henlius has biosimilars of these drugs in phase 1 development currently.

The company is seeking a rheumatoid arthritis indication for its rituximab biosimilar and, if successful, this indication would make HLX01 a bio-innovative medicine because the reference product, MabThera, has not yet been approved for this indication, Cao said. China’s NMPA has accepted a new drug application for HLX01.

Under its current indications, HLX01 was a record breaker, taking 50% of market share for new patients treated within 5 months of launch in China and surpassing market share of the originator product, MabThera, after 14 months on market, Cao said.

Although the cetuximab product candidate remains in early stage trials, Henlius has already granted commercialization rights in China to Shanghai Jingze. The company has multiple nonbiosimilar product candidates in early-stage development and antibody drug combinations in mid- to late-stage development for cancer treatment.

HLX02 (trastuzumab) was the first China-made biosimilar to gain approval in Europe, Cao said. “It has been launched in the United Kingdom, Germany, Portugal, and Spain, and used in tier 1 hospitals of Europe,” she said.

Henlius is working to increase the scale of its manufacturing operations to support its global ambitions for sales growth. It has 2 plants currently: one in Xuhui and a second in Songjian, with a total installed production capacity of 44,000 L. Both of these factories were fitted out and made operational within the past 3 years.

In Sonjiang, Henlius has a third plant in development, which Cao said when complete would rank among the largest biologics production facilities in Asia for size. This plant following phase 1 of development would have 36,000 L of production capacity, which would be increased to 45,000 L later on. Henlius currently has a manufacturing staff of 758 employees, Cao said. “For biologics, the important thing is to reduce manufacturing costs. We have our own proprietary technology to enable this mission.”

The company has its own sales team in China and is looking for partners in the rest of the world. The China sales team numbered 400 full-time employees at the close of 2020 and is projected to reach 1000 full-time workers by the end of 2021. Henlius has established relationships with 2700 upper grade hospitals and 30,000 oncologists in China, Cao said.