Henlius Reports the NMPA’s Acceptance of IND for HLX14 (biosimilar, denosumab)

Henlius Reports the NMPA’s Acceptance of IND for HLX14 (biosimilar, denosumab)

Shots:

  • The NMPA has accepted the IND for HLX14, a biosimilar referencing Prolia, indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture
  • HLX14 is developed in harmony with biosimilar guidelines and was highly similar to the reference product in preclinical pharmacology, toxicology and PK studies
  • Henlius has a robust biosimilar portfolio which includes HLX01 (the first approved biosimilar in China) and HLX03 (adalimumab, biosimilar) & HLX02 (trastuzumab, biosimilar) which are currently under NMPA’s priority review. The development of HLX14 will boost Henlius’ portfolio to cover multiple disease areas

Click here ­to­ read full press release/ article | Ref: Henlius | Image: South China Morning Post