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Dear colleagues,
Time flies. We'll soon bid farewell to 2022 and usher in a new year. On behalf of the Group, I would like to extend my heartfelt gratitude and best wishes to our colleagues all over the world for their hard work and dedication over the past year. Happy New Year!
In 2022, coupled with the pandemic, we witnessed dramatic changes the likes of which have not been seen in a century. China's pharmaceutical industry continues to diversify in an effort to create greater added value, with breakthroughs sought through innovation and transformation. In an era characterized by global turbulence, political and economic uncertainties, the world’s development faces a host of new challenges. In a transitional period such as this, innovation and internationalization are often regarded as powerful tools to address various challenges, while also representing the irreversible industry trend of a shift towards long-term development.
In 2022, we at Luye Life Sciences Group have stayed focused on our strategic therapeutic areas, including the central nervous system, oncology, viruses and pathogens, as well as cardiovascular diseases, making remarkable achievements in innovation and internationalization, despite the challenges. Together with the combined effort of all our colleagues, we have concluded a fruitful year due to our great resilience and hard work.
In the central nervous system (CNS) therapeutic area, we have made remarkable achievements in innovation. Our Class 1 innovative drug Ruoxinlin® (Toludesvenlafaxine Hydrochloride Extended-Release Tablets) has been successfully commercialized in China. The U.S. pivotal trial for Paliperidone Palmitate Injection (LY03010) has met its endpoints, while the Marketing Authorization Application (MAA) for this investigational drug has been accepted in China. The MAA for the Rivastigmine Twice Weekly Transdermal Patch (LY03013) has been accepted in China, while collaborative agreements related to the product have been reached in a number of countries and regions around the world. Additional agreements have also been reached for Seroquel® (Quetiapine Fumarate, immediate release) and Seroquel XR® (extended release formulation) in the global markets. Among our healthcare services business, the first high-end mental health hospital under the Mindfront brand has been launched in China. The brand has also developed and launched an online medical service platform, and an online + offline network of medical services has begun to take shape. We have built and expanded a number of psychiatric hospitals in Australia and put the online mental health service platform into operation, set up a new clinic specializing in dementia, arranged academic conferences and trainings together with authoritative institutions and research professionals, and held psychiatric care and education programs to provide better services for local and overseas patients. In addition, we have begun strategic cooperation with Nhwa Pharma and Haoxinqing, while collaborating with multiple psychiatry experts to launch the “Whole Disease Course Standardized Management for Schizophrenia Patients – Sunflower Program”. With these incredible efforts, we have been continuously developing innovative products and improving services in the CNS field.
In the oncology therapeutic area, the innovative drug Lurbinectedin for treating small cell lung cancer has begun clinical use in Hainan, China, while the New Drug Application (NDA) for the drug has been submitted in Hong Kong, China. The NDA for the innovative formulation Goserelin Acetate Extended-release Microspheres for Injection (LY01005) is also being reviewed in China for the treatment of prostate cancer and breast cancer. Boan Biotech’s investigational drug BA1106, a human anti-CD25 monoclonal antibody, was the first anti-CD25 innovative antibody to enter the clinical stage in China for the treatment of solid tumors, while its first commercialized product Boyounuo® (Bevacizumab Injection) has achieved satisfactory business performance in 2022. Our oncology hospital in Singapore has expanded its medical team to provide more comprehensive services to local and overseas patients. Vela Diagnostics has successfully launched Focused (60 Genes) and Comprehensive (525 Genes) NGS-Based Pan-Cancer Panels, to provide advanced technical support for improving the efficacy and safety of treatment programs for cancer patients.
In the field of viruses and pathogens, BA-CovMab, a broad-spectrum neutralizing antibody candidate against COVID-19, which is highly effective in neutralizing multiple SARS-Cov-2 variants including Omicron, was approved for clinical trials in China. Patronus Biotech's VLP (Virus-Like Particles) technology platform has a proven record in safety and effectiveness, and its vaccine product LYB001 has obtained IND approval in both China and Laos, and has entered into international multi-center Phase III clinical trials. Our Diagnostics team in China has developed second-generation diagnostics tool for detecting antibiotic-resistant Helicobacter pylori, and a PCR assay for the detection of the monkeypox virus. Vela Diagnostics in Singapore has increased the testing throughput of diagnostic products for COVID-19 via a 3-in-1 medium. Geneleap has been driving the development of its mRNA vaccine for HPV, completed the construction of the GMP pilot workshops for manufacturing LNP and mRNA products, as well as applied for a number of patents for its new inventions.
In the field of cardiovascular diseases, Novena Heart Center in Singapore has opened a new clinic, and we have integrated cutting-edge technologies to support rehabilitation, receiving positive feedback from patients. Our core product - Xuezhikang®, the first evidence-based and internationally recognized Chinese lipid-regulating drug to have completed Phase II clinical trials in the U.S., is also recognized and welcomed by more and more cardiovascular patients, showing very exciting growth momentum, with joint efforts together with our strategic partner AstraZeneca.
Also remarkable is that Boan Biotech, a subsidiary of Luye Pharma Group, has been officially listed on the main board of the Hong Kong Stock Exchange, beginning a new journey of development. The company has also successfully launched its second product Boyoubei®, which is the world’s first approved denosumab biosimilar. In addition to the above, we have also made multiple achievements within the Group. Luye Pharma was rated as excellent in the evaluation of the China’s National Enterprise Technology Center, and awarded among the top 10 innovative pharmaceutical companies. Boan Biotech was selected among the top 10 on the list of “Top 100 China Biomedicine Companies”. Luye Life Sciences has signed a memorandum of strategic cooperation on the establishment of the "Innovative Vaccine Center" with the Ministry of Innovation and Development of the Republic of Uzbekistan. It has also joined the SCO Traditional Medicine Industry Alliance as the first group of members.
These accomplishments have not come easily. They are attributed to the joint efforts of all our colleagues and the reflection of the company culture at Luye. In the face of the threat of COVID-19, the vast number of frontline employees and management in our factories, branches and offices around the world were directly affected. However, together we faced these challenges head on, adopting various measures to ensure the safety of employees and maintained smooth operations, with the greatest efforts and dedication to guaranteeing safety in production of our medication, prioritizing the needs of patients. With such an indomitable team spirit at Luye, we can as always achieve the win by working together!
These accomplishments are also attributed to our unwavering commitment to our strategies, and in turn have created new opportunities. During the past 28 years, we have been a pioneer and a practitioner of “innovation” and “internationalization”. Today, this commitment is paying off. Differentiated business divisions are operating under the Group in synch all around the world, with efficient innovation creating a synergetic effect. We are integrating the value chain across the industry to provide medicines and healthcare services that can create added value for our patients.
Looking ahead to 2023, we will continue to explore domestic and international markets following the “dual-circulation” model. I trust the team at Luye Life Sciences will continue to be as courageous and down-to-earth as ever in working to achieve our goals.
At Luye Life Sciences Group, we've long been committed to innovation and internationalization, seeking in-depth development in all our major business fields, always with a patient-centric philosophy. Despite the challenging climate, Luye Life Sciences has begun to reap the benefits of strength built over the years. This would not have been possible without the solidarity, resilience, hard work and courage of our colleagues around the world. I look forward to working together with you to create more value in 2023.
2023 will bear more fruits of our years of commitment to innovation. We expect that more new drugs, new products, new technologies and new services will be successfully launched in China and overseas markets to benefit our patients. We will accelerate the clinical trials and commercialization of key candidates in our pipeline. We will delve deeper into the marketplace with clearly defined priorities. We will take numerous measures to beef up our global commercialization system and operational capabilities. I believe we will see strong growth in both domestic and international markets thanks to our commercial capacity built over the years.
Dear colleagues, we are in a time where disruptive changes are taking place around the world, but this is also a time of unlimited possibilities. The road ahead will not be smooth; there will be challenges and setbacks. However, performance to date has proven the resilience and sustainability of the Group's strategy, and also proved that we have the ability to overcome various challenges, as well as the courage to forge ahead.
Looking forward to 2023, Luye Life Sciences will continue to adhere to its core values, beliefs and strategies. I hope that everyone at Luye Life Sciences will take this historical opportunity, and continue to work hard, in unison, to fulfill our mission and strategic goals. I have the utmost faith in you.
In 2022, we saw both challenges and achievements. In 2023, let’s forge ahead and embrace the bright new future ahead of us.
Best wishes to you! And best wishes to Luye Life Sciences!
Liu Dianbo
Chairman of the Board, Luye Life Sciences Group