China-based Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) has released its 2022 financial report, recording HKD 1.233 billion (USD 157 million) in revenues, marking a 2.6% year-on-year (YOY) decrease. In-licensed products contributed HKD 733 million (USD 93.73 million), accounting for 59.5% of total revenues, while patented drugs and generics made up 40.5% with HKD 500 million (USD 63.69 million). The company reported a net loss of HKD 54.42 million (USD 6.93 million), compared to a net profit of RMB 2.068 billion (USD 299.9 million) in 2021, primarily due to equity sales of subsidiary Zhaoke Ophthalmology Ltd (6622.HK). Research and development (R&D) investment fell by 24.1% YOY to HKD 352 million (USD 44.8 million).
ANDA Approvals and New Drug Developments
During the period, Lee’s Pharma obtained seven approvals for Abbreviated New Drug Applications (ANDAs) and drug importing filings in China. In March, the company received approval for Zingo (intradermal injection system of lidocaine hydrochloride powder) for topical analgesia in children aged 3 to 18 and adults. Additionally, INOmax (inhaled nitric oxide gas) was approved for the treatment of term infants with hypoxic respiratory failure and pulmonary hypertension, as well as premature infants over 34 weeks old.
Strategic Partnerships and Licensing Deals
In July 2022, Lee’s Pharma struck a licensing deal with Unicycive, securing exclusive rights to Renazorb (lanthanum dioxycarbonate) in the Chinese mainland, Hong Kong, and other Asian markets. The company also amended its licensing deal with BioQ to include ropivacaine and 5FU pre-loaded syringes. AU409, developed by Auransa Inc. and manufactured by its Guangzhou unit, obtained clinical trial approval in the United States in 2022.
Robust Product Pipeline in Oncology
Lee’s Pharma boasts a product pipeline exceeding 40 programs, including 6 innovative drugs and 4 generics in the oncology field. Socazolimab, a programmed-death ligand 1 (PD-L1) antibody, is undergoing Phase III studies in osteosarcoma and small cell lung cancer (SCLC) in China. The oral multi-kinase inhibitor zotiraciclib is in a Phase I study for glioblastoma, and topoisomerase I inhibitor gimatecan is in early clinical stages for ovarian cancer, SCLC, and pancreatic cancer in China.-Fineline Info & Tech
