Luye Pharma : Announces 2023 Half Year Results

- Remarkable payoff for innovation -
- Strong revenue growth -
- Accelerated commercialization worldwide -

Luye Pharma Group (2186.HK) announced its 2023 half year results and recent developments on August 29, 2023.

Remarkable sales revenue

During the reporting period, the group's operating revenue was RMB 2,904.1 million, with an EBITDA of RMB 867.3 million.

The sales of product contributed RMB 2,785 million to the operating revenue, growing 18.7% year-on-year. Specifically, the contribution from the sales of oncology products was RMB 810 million, up 34.9% year-on-year, the contribution from the sales of cardiovascular products was RMB 980 million, up 24.8% year-on-year, and the contribution from the sales of central nervous system (CNS) products was RMB 670 million, up 16.5% year-on-year.

Remarkable payoff for innovation

Starting 2021, the group would have 2-3 new products approved for launch each year. In the first half of this year, the group had two new products approved for launch: one was first-in-China, and the other was the only one in the world.

• Rykindo^® (risperidone) for extended-release injectable suspension was approved in the U.S. in January, the first new CNS drug developed by a Chinese company to get approved in the U.S. With a Chinese brand name of 瑞可妥^®, the product is also available in China.
  
• Baituowei^® (goserelin microspheres for injection) was approved in China for the treatment of prostate cancer on June 30, 2023. It is so far the only microsphere formulation of goserelin approved for launch in the world.

Robust growth for mature products

The sales of mature products began to grow again, and some exclusive products further demonstrated their benefits for patients.

• As the world's only marketed paclitaxel liposome formulation, Lipusu^® (paclitaxel liposome for injection) saw rapid sales growth and a significant increase in market share during the reporting period.
  
• Seroquel^® (quetiapine fumarate IR & XR tablets) saw steady growth both in China and abroad as an originator brand, laying a solid foundation for the group's CNS portfolio in terms of brand building and commercialization around the world.
  
• Xuezhikang^®, the only natural lipid-lowering drug in China with clinical benefits demonstrated through hard endpoints, maintained the strong growth momentum during the reporting period. In addition, solid clinical evidence helped make it another success story of TMC in Central Asia.
  
• Oukai^® (sodium aescinate tablets) for the treatment of soft tissue swelling and venous edema set a new sales record again with strong growth potential.
  

Fast sales ramp-up for new products

The group focuses on two key therapeutic areas for new product development: CNS and oncology. Thanks to the successful launch of several new products, the group's revenue stream is evolving from relying on individual products to being driven by a matrix of products acting in concert.

In the therapeutic area of CNS where product development is difficult with relatively fewer players, the group has launched multiple new drugs in China, the U.S., and Europe. These products are acting in concert with products that were already available in international markets including Seroquel^® and the Rivastigmine Transdermal Patch to form a CNS portfolio that holds promise for outperforming competitors and propelling the group to a leading player in the CNS area.

• Ruoxinlin^® (toludesvenlafaxine hydrochloride extended-release tablets) is China's first Class 1 innovative chemical drug for the treatment of Major Depression Disorder developed locally. Since its approval in last November, Ruoxinlin has quickly gained recognition from both physicians and patients for its clinical value. The drug has demonstrated a strong growth momentum, with sales doubling in the second quarter of this year from the first quarter.
  
• The sales of 瑞可妥^® saw remarkable growth in China. More patients are benefiting from it thanks to additional clinical evidence gathered after its launch plus education on standard and holistic management of schizophrenia. Commercial operations for Rykindo have commenced in the U.S. recently.

In the therapeutic area of oncology where the demand for treatments is huge, the group has been introducing competitive new products to cement its leading position in China.

• Baituowei was swiftly put into clinical use within just 19 days after it was approved for launch. The group is partnering with BeiGene to commercialize this product and planning to participate in this year's national negotiations for NRDL coverage.
  
• Boyounuo^® (bevacizumab injection) showed robust growth during the reporting period. All the five indications of this product have been covered by the NRDL, to make it more accessible for patients.
  

Strong pipeline

The group has built a comprehensive and internationally competitive pipeline in key therapeutic areas. 10 projects in the pipeline are under review for marketing authorization and 9 are undergoing Phase III/pivotal clinical studies. This strong pipeline will underpin the group's future growth.

• In CNS: The New Drug Application (NDA) for LY03003 (rotigotine extended-release microspheres for injection) was accepted and granted the priority review designation by China's National Medical Products Administration (NMPA) in August of this year. This product is world's first long-acting extended-release microsphere formulation for the treatment of Parkinson's disease. The group is preparing to file an NDA for LY03010 (paliperidone palmitate injection) in the U.S. The product is also under review for its NDA in China for the treatment of schizophrenia. LY021702 (oxycodone and naloxone extended-release tablets) is also under review for its MAA in China. It is the first product of oxycodone and naloxone extended release tablets with a high technical barrier developed by a Chinese company.
  
• In oncology: The MAA for the breast cancer indication of Baituowei is also under review. LY01017 (lurbinectedin for injection), the only new chemical entity approved by the U.S. FDA for the treatment of recurrent small cell lung cancer (SCLC) in the past 26 years, is under review for its NDA in Hong Kong, Macao, and Mainland China, and has been granted the priority review designation by the NMPA.

In addition, Boan Biotech, a subsidiary of the group, achieved several significant advancements. In the field of biosimilars, the Biologics License Application (BLA) for two products were accepted in China and Brazil respectively, and the Phase III clinical trials of five products were taking place in China and abroad. Furthermore, the IND application for two innovative antibody products was approved.

Strong capabilities in international operations

In recent years, the group has accelerated its pace to launch innovative products abroad. This year, Rykindo was approved for launch in the U.S.; Seroquel and transdermal patch products expanded their presence in the international markets; and Xuezhikang was approved for marketing in Uzbekistan. These achievements once again demonstrated the group's strong capabilities in conducting R&D, regulatory, commercial, clinical and supply chain activities internationally. They are all at the core of the group's effort to build a competitive edge and ensure strong growth in the future.

Boosting growth through M&A

The group is also seeking high-quality and valuable assets and products with a high demand in the marketplace to form a synergy and drive growth in therapeutic areas such as CNS, oncology, cardiovascular diseases, metabolism, and pain. This will enable the group to further expand its pipeline, increase its return-on-investment (ROI), improve R&D efficiency and business operations, and ensure long-term, sustainable growth.

Looking ahead, the group's competitive CNS and oncology pipelines and portfolios will take its overall business to a new level globally. On the one hand, the group will deepen operations in the two strategic therapeutic areas and accelerate the go-to-market process of those products; on the other hand, it will continue to gear up the development of key products and expedite their launch both in China and abroad. This will allow the group to deliver more innovative and differentiated products useful in clinical practice to address the unmet health needs of patients across the globe.