Shanghai Henlius Biotech, Inc
Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 5 products have been launched in China, 1 in Europe, 13 indications approved worldwide, and 2 New Drug Application (NDA) accepted for review in China. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centers. It manufactured and operated in line with global Good Manufacturing Practice (GMP) and built an integrated manufacturing platform with Shanghai-based Xuhui Facility certificated by China and the EU GMP, and Songjiang First Plant certificated by China GMP.
Company details
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- Business Type:
- Manufacturer
- Industry Type:
- Pharmaceuticals
- Market Focus:
- Globally (various continents)
About Us
Henlius has pro-actively built a diversified and high-quality product pipeline covering over 20 innovative monoclonal antibodies (mAbs) and has continued to explore immuno-oncology combination therapies with proprietary serplulimab (anti-PD-1 mAb) as backbone. Apart from the launched products (rituximab), the first China-developed biosimilar, (trastuzumab, Zercepac in the EU), the first China-developed mAb biosimilar approved both in China and in the EU, (adalimumab) and (bevacizumab), the NDA of innovative product (serplulimab) indicated for MSI-H solid tumors has been approved by the NMPA, and the NDA for the treatment of squamous non-small cell lung cancer and extensive small-cell lung cancer (ES-SCLC) are under review.
Up to Now
In addition to 5 products and 13 indications launched commercially and 2 NDAs accepted for review, Henlius has conducted over 20 clinical studies for 12 products and 10 immuno-oncology combination therapies worldwide. (rituximab injection), the first product of Henlius, has been approved by the National Medical Products Administration (NMPA) as China's first biosimilar. The second product (trastuzumab, Zercepac® in the EU) is the first Chinese mAb biosimilar approved both in the EU and China, bringing more treatment options to patients with HER2 positive breast and gastric cancer worldwide. In March 2022, the company’s first self-developed innovative monoclonal antibody, (serplulimab injection), was approved by the NMPA for the treatment of Microsatellite Instability-High (MSI-H) solid tumors. Meanwhile, and the NDA for the treatment of squamous non-small cell lung cancer and extensive small-cell lung cancer (ES-SCLC) are under review.