China-based Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) has released its H1 2022 interim financial report, recording HKD 649 million ($82.6 million) in revenue, up 11.1% year-on-year (YOY). The growth was driven by products such as Bredinin (mizoribine), treprostinil, and interferon α2b, which offset declining sales of Ferplex (iron protein succinylate) and other out-patient drugs, as well as nadroparin, hemocoagulase, and other surgery products.
Revenue Breakdown and R&D Focus
Sales of in-licensed products accounted for 61.2% of the group’s total revenue in H1 2022, up from 57.3% in H1 2021. Proprietary and generic products contributed 38.8% of total revenue, down from 42.7% a year ago. Research and development (R&D) expenses were focused on major new assets in therapeutic areas such as cardiovascular, women’s health, pediatrics, rare diseases, dermatology, and obstetrics, as well as in oncology under a separate R&D arm within the group.
Late-Stage Programs and R&D Expenditure
Late-stage programs include Cetraxal Plus for acute otitis externa (AOE) and acute otitis media with tympanostomy tubes (AOMT), which has just completed a Phase III trial and is expected to be filed for approval in China in September this year. Intrarosa for the treatment of vulvovaginal atrophy (VVA) is currently in Phase III trials with patient enrollment progressing. The company spent HKD 206.5 million ($26.3 million) on R&D in H1 2022, down 14.0% compared to the same period last year.
Net Profits and Future Outlook
Overall, net profits attributable to the owners of the company were HKD 28.4 million ($3.6 million), down 98.7% year-on-year. The group currently has over 40 projects in its pipeline, ranging from early- to late-stage development. New Drug Applications (NDA) for Adasuve and Abbreviated New Drug Applications (ANDA) for azilsartan, epinastine hydrochloride tablets, and apremilast tablets are under review by the Centre for Drug Evaluation (CDE) in China.
Lee’s won a volume-based procurement (VBP) program tender for fondaparinux sodium, and it is expected that more products, such as low molecular weight heparin, will enter forthcoming VBP tenders. The firm’s Carnitene is viewed as a potential target for the upcoming VBP program, and with its licensing agreement expiring in the second half of 2022, Lee’s aims to develop a domestic generic version to maintain market share.-Fineline Info & Tech
