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Henlius Reports the NMPA's Acceptance of IND for HLX14 (biosimilar- denosumab)

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Henlius Reports the NMPA's Acceptance of IND for HLX14 (biosimilar- denosumab)

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  • 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


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