Biotech & Genomic Medicine▲3
Lingkang Pharmaceutical Subsidiary Receives Drug Registration Certificate for Isavuconazonium Sulfate for Injection
Lingkang Pharmaceutical announced that its wholly-owned subsidiary Hainan Lingkang Pharmaceutical has received the Drug Registration Certificate for Isavuconazonium Sulfate for Injection approved and issued by the National Medical Products Administration. The specification is 0.2 grams, the registration classification is Category 4 chemical drug, and it is deemed to have passed the consistency evaluation. The drug is indicated for the treatment of invasive aspergillosis and invasive mucormycosis infections in adult patients. The company first submitted the domestic drug registration application in December 2024 and it was accepted, with cumulative research and development investment of approximately 7.32 million yuan. The company stated that this approval marks its qualification for production and sales in the domestic market, further enriching its anti-infective product line and helping to enhance market competitiveness, but the launch and sales of the drug are still subject to uncertainties.
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603669.CG · Regulation · Positive Subsidiary received NMPA Drug Registration Certificate for Isavuconazonium Sulfate for Injection, gaining production and sales qualification in China.