Goserelin Microspheres for Injection Approved for Launch in China
2023 / 07 / 05 Publisher：Luye Life Sciences Group
- Luye Pharma and BeiGene announce a strategic partnership for the commercialization of this product, the only one in the world -
- Providing a new ADT that is effective and safe with a better experience for China’s prostate cancer patients -
Shanghai, July 4, 2023 -- Luye Pharma Group (HKEX: 02186) and BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235) have announced that Luye Pharma's innovative formulation, Goserelin Microspheres for Injection (Baituowei), was approved by China’s National Medical Products Administration (NMPA) on June 30, 2023, for the treatment of prostate cancer in patients who need to be treated with an androgen deprivation therapy (ADT). This product is the world’s first and only formulation of long-acting goserelin microspheres approved for launch, and the two companies have officially kicked off a strategic partnership for its commercialization.
The only one in the world with clear superiority in clinical performance
Prostate cancer is the second most commonly diagnosed cancer in men and the fifth leading cause of death among men worldwide. In China, the new cases of prostate cancer are growing 7.1% a year on average, the highest among all cancers in men1. It poses a serious threat to the health of men and their quality of life.
Professor Dingwei Ye, Vice President of Fudan University Shanghai Cancer Center and head of the center’s multidisciplinary team (MDT) for genitourinary cancers, said: “The most common practice in treating prostate cancer is using an ADT, typically a gonadotropin-releasing hormone (GnRH) agonist. However, patient compliance is an issue with a traditional subcutaneous implant, as it is difficult to inject and therefore has some requirements for the injection environment and the training of medical workers. Besides, administering it is usually a painful experience for patients. With the upgraded microsphere formulation and improved injection style, Baituowei is effective and safe to use, providing a better patient experience. It is a new and better option for treating prostate cancer in clinical practice2.”
With its innovative microsphere formulation, Baituowei is able to release the active ingredients more steadily within a treatment cycle, to achieve better control over testosterone production, and to ensure efficacy and safety. The improved needle for this product has a diameter of only 0.8 millimeters. This can significantly improve patient experience. In a Phase III clinical trial of Baituowei for the treatment of prostate cancer, its efficacy was comparable to that of the reference drug, and its safety profile was similar to that of the reference drug. Besides, this product was found to be able to significantly reduce the incidence and severity of adverse reactions at the injection site, so as to improve patient tolerance and compliance, making it clearly superior over the reference drug.
A strong partnership to reshape the market and serve more patients
Prostate cancer significantly damages the physical and mental health of patients and compromises their quality of life. For approximately 40%3 of the patients, their family members also suffer from depression or anxiety. Currently, goserelin is commercially available in a subcutaneous implant formulation. Patients want to have a new option that can provide a better treatment experience while ensuring efficacy and safety.
To bring this new medicine to more patients in need faster, Luye Pharma and BeiGene formed a partnership for its commercialization. In this partnership, the latter is granted the exclusive research, development and commercialization rights to the product in Mainland China, and Luye Pharma as the product’s Marketing Authorization Holder (MAH) will manufacture and supply it based on the demand forecast by BeiGene. In China, BeiGene has built strong commercial leadership, achieving a large-scale of over 3000 employees with science- and medicine- based advantages. Its growing commercial portfolio contains 17 products covering solid tumors and hematological malignancies of high incidence.
"We are excited to welcome the approval of Baituowei for the treatment of prostate cancer and we are confident that, through the strong partnership with Luye Pharma, we will be able to leverage our strong commercial capabilities in China to bring Baituowei to more eligible patients with its proven efficacy, safety and better treatment experience.” commented Xiaobin Wu, Ph.D., President, Chief Operating Officer, and General Manager of China, at BeiGene. “As a global biotechnology company, BeiGene is continually expanding and improving its capabilities to bring, alone or through collaborations, global innovative medicines of the highest quality to as many patients as possible.”
Mr. Dianbo Liu, Executive Chairman of Luye Pharma Group, said: "At Luye Pharma, we work relentlessly to offer clinically viable and differentiated innovative products that can improve outcomes for patients. The approval of Baituowei as the only microsphere formulation of goserelin has again demonstrated our determination and commitment to serving patients through our leading microsphere platform. We look forward to working closely with BeiGene to make this innovative option available to as many patients as possible and at a faster speed."
In addition to prostate cancer, Baituowei is also being reviewed for its New Drug Application (NDA) in China for the treatment of breast cancer. Data from IQVIA shows that the total size of the market for GnRH agonists in China was approximately RMB 9.5 billion in 2022, with a compound annual growth rate (CAGR) of 17.7% from 2018 to 2022. Due to the huge unmet needs of patients, it is expected that Baituowei will have a very promising market after its launch.
About Prostate Cancer
Prostate cancer is the second most common cancer in men and the fifth leading cause of cancer death among men worldwide. In 2020, there were approximately 1.4 million new cases and 375,000 deaths4. In recent years, the incidence of prostate cancer in China has been increasing at 7.1% a year, the highest among all cancers in men. The five-year survival rate for Chinese prostate cancer patients is approximately 66.4%5, lower than the 95% or higher five-year survival rate in developed countries6. Due to atypical early symptoms and the low coverage of the prostate-specific antigen (PSA) test, around 40% to 70% of China’s prostate cancer patients are already found to have regional or distant metastasis upon initial diagnosis7. Treating with an androgen deprivation therapy, typically a gonadotropin-releasing hormone agonist, is the most common practice for treating prostate cancer patients throughout their treatment journey8.
About Baituowei (Goserelin Microspheres for Injection)
Developed by Luye Pharma, Baituowei (Goserelin Microspheres for Injection) is designated as a “Class 2.2 new chemical drug” in China. It is an innovative formulation developed on the microsphere platform of the National Key Laboratory of Advanced Drug Delivery and Release Systems, and manufactured following the company’s quality management system that is compliant with the Chinese GMP, the U.S. cGMP and the EU GMP systems.
About Luye Pharma Group
Luye Pharma Group is an international pharmaceutical company dedicated to the R&D, manufacturing and sale of innovative medications. The company has established R&D centers in China, the U.S. and Europe, with a robust pipeline of over 30 drug candidates in China and more than 10 drug candidates in other international markets. Luye Pharma maintains high-level international standards in novel drug delivery technologies including microspheres, liposomes, and transdermal drug delivery systems. The company has also achieved multiple innovations in new chemical entities and antibodies, and is actively making strategic developments in the fields of cell therapies and gene therapies.
Luye Pharma is developing a global supply chain of 8 manufacturing sites built up around the world, with GMP quality management and control systems established in line with international standards. With more than 30 products covering the central nervous system, oncology, cardiovascular, metabolism and other therapeutic areas, business is conducted in over 80 countries and regions around the world, including the largest pharmaceutical markets - China, the U.S., Europe and Japan, as well as in fast growing emerging markets.
For more information, please visit: www.luye.cn/lvye_en
BeiGene is a global biotechnology company that is discovering and developing innovative oncology treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, the company is expediting development of its diverse pipeline of novel therapeutics through our internal capabilities and collaborations. BeiGene is committed to radically improving access to medicines for far more patients who need them. Their growing global team of more than 9,400 colleagues spans five continents, with administrative offices in Beijing, China; Cambridge, U.S.; and Basel, Switzerland. To learn more about BeiGene, please visit www.beigene.com and follow them on Twitter at @BeiGeneGlobal.
- ZHENG R S, et al. Cancer incidence and mortality in China, 2016[J]. JNCC, 2022.2(1):1-9
- Results of a Phase III clinical trial of goserelin microspheres for injection in treating prostate cancer, Chinese Medical Journal
- Tao Jiang, Lianzhen Xiao, Yalan Ding. et al. A study on the anxiety and depression status of family members of patients with advanced prostate cancer. Academic Journal of Guangzhou Medical University. Vol. 50 No. 5
- World Cancer Report 2020, International Agency for Research on Cancer
- Zeng H, Chen W, Zheng R, et al. Changing cancer survival in China during 2003–15: a pooled analysis of 17 population-based cancer registries[J]. The Lancet Global Health, 2018, 6(5): e555-e567.
- National Cancer Report 2022, National Cancer Center of China
- Advancements in Basic Research and Clinical Diagnosis and Treatment of Prostate Cancer in 2022, Pan Jian, Zhu Yao, Dai Bo, Ye Dingwei, Department of Urology, Fudan University Shanghai Cancer Center
- Guidelines for the Diagnosis and Treatment of Prostate Cancer (2022 Edition), National Health Commission