Product sales have grown steadily, and the financial structure has been significantly optimized

SHANGHAI, March 27, 2024/PRNewswire/ -- On March 27, Luye Pharmaceutical Group (2186.HK) announced its 2023 annual results and business progress to date.

During the reporting period, the Group's revenue was about 6.14 billion yuan, up 2.7% year on year; EBITDA was about 2.08 billion yuan, up 14.6% year on year; profit before tax was about 70 billion yuan, up 4.5% year on year. The Group's balance ratio was approximately 46.9%, down 7.6 percentage points from the previous year.

Among operating income, product sales revenue was approximately RMB 5.63 billion, an increase of 11.2% over the previous year. Among them: Sales revenue of oncology products was about 1.92 billion yuan, up 26.3% year on year; sales revenue of central nervous system (CNS) products was about 1.39 billion yuan, up 14.8% year on year. The sales revenue of cardiovascular products was about 1.69 billion yuan, an increase of 10.8% over the previous year.

New drugs have been intensively approved, injecting new impetus into performance growth

Focusing on the two core treatment fields of oncology and CNS, the Group has laid out a new drug pipeline for many years and has entered a good harvest period. New drugs have been intensively approved in recent years, injecting new impetus into the Group's performance growth.

Oncology field

Two new drugs were approved during the reporting period to fill unmet clinical needs.

Baituo(Injectable goserelin microspheres) approved for the treatment of prostate cancer and breast cancer in China, and is the only long-acting goserelin microsphere preparation approved for marketing in the world. The product entered the national medical insurance drug catalogue in the same year, and patient coverage expanded significantly.

Zepzelca(Rubitidine for injection) has been approved in Macau, China and Hong Kong, China, and is expected to be the first to benefit mainland patients through the Guangdong-Hong Kong-Macao Greater Bay Area's “Hong Kong and Macau Drug Connect” policy. This product is the only new chemical entity approved by the US FDA for the treatment of recurrent small cell lung cancer in the past 27 years.

CNSspheres

New drug pipelines and marketed varieties touch major global pharmaceutical markets, comprehensively covering various diseases in the CNS field, demonstrating the leading value nurtured by the Group in the CNS field. Three new drugs were approved in 2023, further strengthening the Group's competitive advantage in this field.

Additionally, it is worth mentioning:Rykindo(Risperidone sustained-release microsphere injection) was approved in the US for the treatment of schizophrenia and bipolar disorder during the reporting period, and commercialization was actively promoted; this product is the first new CNS drug independently developed in China and approved in the US. The product continued to grow rapidly domestically, and maintained the original medical insurance payment standards in the 2023 National Medical Insurance Drug Catalogue and was successfully renewed.

Ruoxin Lin(Toludivenlafaxine hydrochloride sustained-release tablets) As the first self-innovated Class 1 innovative chemical drug to treat depression in China, sales growth broke through after being approved for marketing in November 2022. It achieved impressive results in the first full year of sales in 2023, and its clinical value was quickly recognized by doctors and patients.

Mature products are rising steadily, consolidating revenue fundamentals

Focusing on the three major treatment fields of oncology, CNS, and cardiovascular disease, the Group's mature product core varieties are growing steadily, and various exclusive products highlight treatment advantages and market competitive advantages, and firmly support the Group's performance fundamentals.

lipopexin(Paclitaxel liposomes for injection) increased significantly in market share during the reporting period;Sirikang(quetiapine fumarate tablets, extended-release tablets),Blood Fat HealthSteady growth in sales;Oukai(Aesculin sodium tablets) has continued to be released at a high rate in recent years, and the growth trend is strong.

Major products will accelerate, and international business will achieve new breakthroughs

exceptRykindoOther than those approved in the US for the treatment of schizophreniaLY03010(Paliperidone Palmitate Sustained Release Suspension Injection)It also entered the review stage for new drug marketing applications in the US during the reporting period, and patent barriers have been removed during the review process, and it is expected that it will be approved in the US as early as this year.

The pipeline reserves are abundant,5The new product is expected to be approved this year

The Group has abundant reserves in the research pipeline. Many ongoing research projects are already in the marketing review stage and phase III/key clinical trial stage, and commercialization momentum is strong. The following 5 new products are expected to be approved this year:

Oncology field：

• rubitidine for injectionIt is expected to be approved in mainland China;
• BA1102(Dexumab injection, Angarvirbiosimilar)It is expected to be approved in China;

CNSspheres：

• LY03010(Paliperidone Palmitate Sustained Release Suspension Injection)It is expected to be approved in China and the US. This product is expected to be the first domestically produced paliperidone palmitate long-term injection approved in the US with independent intellectual property rights;
• LY03003(Rotigotin sustained-release microspheres for injection)It is the world's first long-term slow-release microsphere preparation for Parkinson's disease, and is expected to be approved in China;
• LY021702(oxycodone naloxone sustained-release tablets)It is the first high-tech oxycodone naloxone sustained-release tablet developed by a domestic company for moderate to severe chronic pain, and is expected to be approved in China;

Furthermore,BA5101(Dulagopeptide injection, Duyidabiosimilar)Phase III clinical trials have been completed in China, and it is planned to submit a marketing application (BLA). This product is the first in the world to complete a phase III clinical trial.Biosimilar drugs are currently leading the way in development. In addition, a number of innovative antibodies and biosimilar drugs are undergoing clinical trials at home and abroad.

Looking forward to the future and starting a new round of rapid growth

On the occasion of the 30th anniversary of the Group's establishment in 2024, the first batch of innovative varieties of the Group's multi-year layout has been intensively implemented, ushering in a good harvest. We expect these products to better serve the urgent clinical needs and drive the Group to start a new round of leapfrog growth in China and overseas markets. Looking forward to the future, on the one hand, the Group will make every effort to promote the excellent listing and commercial operation of core products in domestic and overseas markets to accelerate the transformation of products from clinical value to commercial value; on the other hand, the Group will also improve operational and management efficiency through a series of measures, continuously improve the Group's profitability, and create greater value for patients, shareholders, and society.