China-based Luye Pharma Group (HKG: 2186) has released its 2022 financial report, recording a total revenue of RMB 5.982 billion (USD 869.8 million), marking a 15.0% year-on-year (YOY) increase. The company’s performance reflects significant growth, particularly in its tumor treatment sector, which saw a 63.1% increase to RMB 2.306 billion (USD 335.2 million). Cardiovascular drug sales also experienced a 7.6% rise, reaching RMB 1.536 billion (USD 223.3 million), while central nervous system treatments were relatively stable with a minor 0.1% decrease to RMB 1.323 billion (USD 192.3 million). The digestive and metabolic treatment segment faced a more significant decline, dropping by 29.6% to RMB 632 million (USD 91.89 million).
R&D Expenditure and Profitability
During the year, Luye Pharma’s R&D expenditure increased by 25.5% YOY, amounting to RMB 857 million (USD 124.6 million). The company turned a profit for the first time, generating RMB 583 million (USD 84.7 million) in net profits, a stark contrast to the RMB 144 million (USD 20.9 million) net loss reported in the previous year.
Product Development and Market Expansion
As of December 31, 2022, Luye Pharma achieved marketing and indication expansion for 11 major products and had 35 products under development in China. Notably, its biosimilar version of Roche’s Avastin (bevacizumab) received market approval to treat various types of cancer in February 2022, with all indications included in the National Reimbursement Drug List (NRDL) in January 2023. LY06006/BA6101, a biosimilar of Amgen’s Prolia (denosumab), became the first of its kind globally to earn approval in China in November 2022. LY03005, a Category 1 chemical drug for depression, received approval in China, while Rykindo (risperidone) extended-release injectable suspension gained market approval in the US for schizophrenia and bipolar I disorder treatments. The rivastigmine multi-day transdermal patch for Alzheimer’s disease also secured multiple marketing approvals in Europe.
Upcoming Milestones and Expectations for 2023
Luye Pharma anticipates obtaining marketing approval for its goserelin acetate sustained-release injectable microspheres (LY01005) in China in 2023, positioning it as the world’s only product of its kind. Lurbinectedin (LY01017), an RNA polymerase II inhibitor approved for recurrent small-cell lung cancer in the US, is expected to gain approval in Hong Kong and is being prepared for market filing in mainland China. The company also has six products under marketing review and eight programs at Phase III/pivotal/market filing preparation stages.-Fineline Info & Tech
