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Henlius Anti-CTLA-4 Monoclonal Antibody HLX13 Received IND Application Acceptance Notification from NMPA


Shanghai, China, Janurary, 2020 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that an investigational new drug (IND) application has been accepted by the National Medical Products Administration (NMPA) for HLX13, a recombinant anti-CTLA-4 fully human monoclonal antibody injection independently developed by Henlius.

HLX13 is a biosimilar of ipilimumab (originator trade name: Yervoy®, a fully human, anti-CTLA-4, IgG1 monoclonal antibody with κ lightchain). It can be potentially used in the treatment of  the following indications: 1. unresectable or metastatic melanoma; 2. adjuvant treatment of melanoma; 3. advanced renal cell carcinoma; and 4. microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer. Pursuant to the Technical Guidelines for R&D and Evaluation of Biosimilars (For Trial Implementation), the Company conducted a head-to-head comparison between HLX13 and the reference ipilimumab, in terms of their respective pre-clinical pharmacology, pharmacokinetics and toxicology. The findings from the comparison shows that the pharmacodynamics  (both in vitro and in vivo), the pharmacokinetics and toxicokinetics profiles and also the immunogenicity and toxicology profiles of HLX13 and reference ipilimumab, respectively, are similar to, or have no significant difference between, each other.

Henlius actively implements the product development strategy and has established a pipeline that covers several advanced mAb biosimilar candidates with the potential to be commercialized in the near term. In February 2019, HLX01 (汉利康®,rituximab injection), the first product independently developed by Henlius has been granted NDA approval by the NMPA for the treatment of non-Hodgkin’s lymphoma, making it the first biosimilar approved in China. Leveraging the development experience of biosimilar, Henlius is developing comprehensive bio-innovative pipeline and driving worldwide clinical studies of novel products. In addition, Henlius actively diversifies versatile in-house combination therapy portfolio with a focus on anti-PD-1/PD-L1 mAb to capture future immuno-oncology opportunities to provide affordable and effective therapies for patients worldwide.

About Henlius

Henlius (2696.HK) is a leading biopharmaceutical company in China with the vision to offer high-quality, affordable and innovative biologics for patients worldwide with a focus on oncology and autoimmune diseases. Since its inception in 2010, Henlius has built an integrated and efficient global R&D platform with key facilities in Shanghai, Taipei and California. The three R&D centers closely collaborate with each other to ensure a highly productive and cost-efficient R&D process. Starting from biosimilar, Henlius presses forward with novel mAb products and immuno-oncology combination therapies with proprietary anti-PD-1 and PD-L1 mAbs as backbone. Henlius establishes a diversified product pipeline of biosimilars, bio-innovative drugs and combination therapies, and builds an integrated platform covering the whole product lifecycle including R&D, commercial-scale production and commercialization. On September 25, 2019, Henlius was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 2696.HK.

Until now, in addition to one product launched commercially, two products under New Drug Application (NDA) review and one product under Marketing Authorization Application (MAA) review, Henlius has conducted over 20 clinical studies for 14 products and 7 combination therapies worldwide. HLX01 (汉利康®, rituximab injection), the first product of Henlius, has been granted approval by the NMPA as the first approved biosimilar in China. HLX03 (adalimumab injection) and HLX02 (trastuzumab for injection) have their NDA under priority review by the NMPA. HLX02 is also the first China-manufactured biosimilar developed in a global setting. In June 2019, the MAA for HLX02 was accepted for review by EMA. Moreover, Henlius advances immuno-oncology combination therapies with proprietary mAbs including HLX10 (anti-PD-1 mAb) as backbone in combination with chemotherapy and other mAbs including HLX04 (bevacizumab biosimilar) and HLX07 (anti-EGFR mab). The global multi-center clinical trials are ongoing in various countries and regions worldwide.