This year, GlaxoSmithKline (GSK), a global biopharmaceutical company with the mission of "gathering science, technology, and talent, working together to overcome diseases", once again appeared on the stage of the 6th China International Import and Export Fair.
Thanks to the "spillover effect" of previous CIIE, GSK has successfully achieved the introduction and accessibility acceleration of multiple innovative medical products, demonstrating outstanding performance in the field of specialty drugs. The world's first approved targeted human interleukin-5 monoclonal antibody biologic formulation, Xinkelai (commonly known as Mebolizumab Injection), will make its third appearance at the Expo. The biological agent Beiliteng (commonly known as Belizumab for injection) in the field of lupus treatment has made five appearances at the China International Trade Fair, and its "Chinese ID card" is updated almost every year. What other performances will GSK have on the stage of entering the blog? As a biopharmaceutical company, how will it deeply integrate into China's healthcare reform and benefit patients?
Yu Jinyi, Vice President of GSK China and Head of GSK China Specialty Medicine and Respiratory Business, introduced that GSK Specialty Medicine will debut on the stage of the 6th CIIE with two biological agents - Xinkelai and Beiliteng. In the following year, GSK will actively promote the approval of these two new indications for biological agents to meet the treatment needs of more Chinese patients in related fields.
Layout special drug pipelines to accelerate the expansion of indications
As the world's first approved targeted human interleukin-5 (IL-5) monoclonal antibody biological agent, GSK's heavyweight biological agent Shinkelai has made three appearances, with new surprises every time: Shinkelai made its debut at the International Trade Fair in November 2021, and the same year, China's State Drug Administration approved Shinkelai to be launched in China for the treatment of adult eosinophilic granulomatous polyangitis (EGPA). Subsequently, the first batch of prescriptions were officially launched. In the past three years, thanks to the "spillover effect" of the CIIE, Xinke has completed a magnificent transformation from the first exhibition to the first place. At present, the newly available indications for EGPA have not only been included in medical insurance, but it is worth mentioning that EGPA has been included in the new rare disease list in China this year.
The so-called interleukin-5 (IL-5) itself is an inflammatory factor in the body. As the world's first targeted human anti interleukin-5 (IL-5) monoclonal antibody biologic approved for the treatment of adult EGPA, Xinkelai has been applied in other indications abroad, mainly due to a series of abnormal inflammatory reactions caused by IL-5 in the body. For example, IL-5 attacks the upper respiratory system, leading to asthma and sinusitis; When it infiltrates into nerve endings and skin, it becomes EGPA. Based on this, GSK plans a series of indications for the entire IL-5 related inflammatory pathway. In the future, this biological agent is expected to expand its indications for severe eosinophilic asthma (SEA), chronic sinusitis with nasal polyps (CRSwNP), and eosinophilic chronic obstructive pulmonary disease (COPD), benefiting more patients.
With China's increasing attention to the field of rare diseases in recent years, the research and development of treatment products, indication development, and medical security in the field of rare diseases have all entered the fast lane. Taking Xinkelai as an example, it was launched overseas in 2015, and clinical trials for Severe Eosinophilic Asthma Indication (SEA) had already been initiated in China, but the overall progress was relatively long. Afterwards, with the issuance of the "Temporary Import Work Plan for Clinical Urgent Drugs" by the National Health Commission and the National Drug Administration, starting from 2019, imported urgently needed drugs can quickly enter China and land. Based on this advantage, Xinkelai has been approved with EGPA rare disease indications, entering China as soon as possible to ensure timely medication for Chinese patients.
Yu Jinyi revealed that the National Drug Administration has currently accepted applications for new indications for severe eosinophilic asthma in China, hoping that this revolutionary therapy can accelerate its benefits to Chinese SEA patients. At the same time, GSK is also exploring the possibility of upgrading interleukin-5 treatment to long-term treatment, which is expected to significantly improve patient compliance and treatment convenience. In the future, GSK will continue to introduce other new indications that can be introduced.
Accelerate accessibility and assist in patient rebirth
Beili Teng has made five appearances at the International Fair, almost updating its "Chinese ID card" every year. In July 2019, Beili Teng was approved in China and subsequently made its debut as the world's and China's first biological agent approved for the treatment of adult systemic lupus erythematosus. Its approved indications in China were expanded to children with systemic lupus erythematosus and adult lupus nephritis after entering the expo in 2020 and 2021, respectively, becoming the world's first biological agent to cover the indications for adult and child systemic lupus erythematosus and adult lupus nephritis. At the same time, it is also the only biological agent recommended by the Chinese guidelines, EULAR guidelines, and KDIGO guidelines, and has been approved by the China National Drug Administration for the treatment of systemic lupus erythematosus.
The introduction of innovative biological agents through the advantage platform of the CIIE has deeply benefited Chinese patients. The time can be traced back to 2019, when Beili Teng was launched in China, breaking the situation where there have been no new drugs available in the lupus field in China for 60 years. It has been four years since the launch of Beiliteng, benefiting over 50000 Chinese patients, including adult and child systemic lupus erythematosus patients, as well as adult lupus nephritis patients.
What are the advantages of biological agents compared to traditional drugs? Lupus is an autoimmune disease that may affect multiple organs and systems throughout the body and is prone to recurrence, with each recurrence exacerbating organ damage. Clinical data shows that with the development of rheumatoid immunology in China, the 5-year survival rate of patients has increased to over 95%. However, in the long run, the 25-30 year survival rate has plummeted to 30%. This can be said to be a 'cliff like decline'.
The emergence of the breakthrough treatment plan of Beiliteng not only enables short-term and long-term effective control of lupus disease, but also improves the quality of life of patients. Targeting on key pathogenic factors, Beiliteng can quickly reduce lupus disease activity, reduce recurrence, and achieve long-term organ protection. In addition, the long-term use of biological agents makes it possible to reduce the dosage of traditional therapeutic drugs, helping doctors and patients achieve organ protection, which is of great significance for improving the long-term quality of life of lupus patients.
It is gratifying that in 2022, Beiliteng was approved as an indication for adult lupus nephritis. This year, GSK is actively participating in national medical insurance negotiations, hoping to enable more patients suffering from lupus nephritis to receive biological treatment and obtain medical insurance protection.
Be optimistic about the Chinese market and deeply cultivate a culture of "caring for patients"
Medical progress is advancing rapidly, and treatment methods are constantly being updated. For GSK, it is very important to enhance industry awareness and promote the updating of standardized treatment standards. Yu Jinyi stated that GSK is continuously innovating and making efforts in high-quality academic promotion, doctor education, and enhancing patients' disease awareness. Whether accelerating the introduction of innovative products and improving accessibility, or promoting standardized diagnosis and treatment levels, improving disease awareness, and helping to improve patient quality of life, these multi-dimensional efforts are all manifestations of GSK's corporate culture of "caring for patients".
During last year's CIIE, the "Standardized Diagnosis and Treatment Project for Systemic Lupus Erythematosus", sponsored by the China Medical and Health Development Foundation, with academic support from the National Clinical Research Center for Dermatology and Immunology, and jointly initiated by GSK China, officially released the "Principles for the Construction and Management of Standardized Diagnosis and Treatment Centers for Systemic Lupus Erythematosus" in 2023 after signing a strategic cooperation memorandum, And initiate the certification of standardized diagnosis and treatment centers for systemic lupus erythematosus.
This project strengthens the cultivation of professional talent teams nationwide, radiates the surrounding areas through diagnosis and treatment centers, and establishes high-quality and standardized treatment models to improve the prognosis and quality of life of patients with systemic lupus erythematosus. The project plan is to continue promoting the certification of demonstration centers and diagnosis and treatment centers nationwide in 2024, as well as hospital visits and exchanges, to improve the standardization of diagnosis and treatment of systemic lupus erythematosus in the field of rheumatism and immunity nationwide.
At the same time, GSK actively responds to the country's call to continuously improve the accessibility and affordability of drugs by participating in national medical insurance negotiations and centralized procurement of drugs. The indications for newly acquired eosinophilic granulomatous vasculitis were included in the national medical insurance catalog only one year after being approved. In 2020, the indications for systemic lupus erythematosus in Beiliteng were included in the 2020 national medical insurance catalog; In the second year, indications for systemic lupus erythematosus in children were included in the 2021 National Medical Insurance Catalogue, demonstrating GSK's determination to improve patient drug accessibility and affordability.
In order to further enhance the accessibility of negotiated drugs, GSK actively cooperates with the government to introduce a "dual channel" new policy, leveraging the wide distribution of designated retail pharmacies and high market flexibility, complementing medical institutions, increasing the medication choices of insured patients, and solving the problem of patients not being able to purchase drugs listed in the medical insurance catalog.
Yu Jinyi finally stated that GSK has always been firmly rooted in the Chinese market, making every effort to meet the unmet needs of Chinese patients, and bringing revolutionary drugs to the Chinese people with a wide range of health impacts. In the future, GSK will continue to increase its investment in the Chinese market and spare no effort to benefit the vast number of Chinese patients with innovative medical solutions.