Luye Pharma : The World’s Only Goserelin Microsphere Formulation (Baituowei) Approved in China for the New Indication of Breast Cancer

Shanghai, September 7, 2023 -- Luye Pharma Group (HKEX: 02186) and BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235) today announced that a new indication for Luye Pharma's innovative formulation, Goserelin Microspheres for Injection (Baituowei), has been approved by China's National Medical Products Administration (NMPA): to be used for treating breast cancer in premenopausal and perimenopausal women that can be treated with hormones.

Since the approval of Baituowei in China for the treatment of prostate cancer on June 30 this year, Luye Pharma and BeiGene have been working together to accelerate the commercialization of the product. The approval of the new indication will further expand the patient groups that can benefit from Baituowei.

Breast cancer is the number one malignancy threatening women's health worldwide, and is also a type of highly prevalent cancer in Chinese women. In 2020, China had 420,000 new cases of breast cancer¹, and the incidence was growing in different age groups². Breast cancer also tends to have an earlier onset in China than in Europe and the United States³, which premenopausal breast cancer patients in China account for approximately half of all the patients. The premenopausal patients also have a higher risk of relapse and a lower overall survival rate compared with the elder ones. ⁴

Professor Wang Xiaojia, Director of the Department for Breast Cancer at Zhejiang Cancer Hospital and Vice Chairman of the CSCO Breast Cancer Committee, said:" Premenopausal women with breast cancer have higher and more personalized requirements for preserving fertility, maintaining breast shape, getting a better treatment experience, living a better life, receiving better mental care, and reintegrating into society. Therefore, we need to take multiple factors into consideration and give them more care in clinical practice. The upgraded microsphere formulation and modified injection needle of Baituowei can keep a balance of efficacy, safety and patient experience, effectively reduce the stress of patients, substantially increase their confidence and compliance for treatment, and help them eliminate concerns and get back to life as soon as possible."

Baituowei is the world's first and only approved microsphere formulation of Goserelin. With its innovative microsphere formulation, Baituowei is able to ensure efficacy and safety while significantly improving patient experience. In a Phase III clinical trial of Baituowei for the treatment of breast cancer, its efficacy and safety profile were found to be comparable to those of the reference drug. In addition, Baituowei could significantly reduce the incidence and severity of adverse reactions at the injection site. Its modified needle has a diameter of only 0.8 millimeters, to effectively reduce patients' psychological burden and fear associated with the treatment, and to improve patient confidence and compliance. In short, it was found to be clearly superior over the reference drug.

Ms. Eva Yin, Chief Commercial Officer of BeiGene Greater China, said: "Female patients play a variety of roles in society, family, workplace, etc. They have personalized needs for treatment and prognosis, and are longing for better quality of life. We are excited to welcome Baituowei's the new indication approved for breast cancer and are very clear about the large unmet needs and the value of product. We are looking forward to bringing better treatment for China's breast cancer patients, reducing their physical and mental burdens and helping them get back to life. BeiGene will continue to collaborate with Luye Pharma and commit to provide medicines of efficacy, safety and experience to be accessible to as many patients as possible."

Mr. Rongbing Yang, President of Luye Pharma Group, said: "We are very proud of a new indication approved for Baituowei shortly after its commercial launch and we both parties are optimistic about the product's market prospect. This milestone has again demonstrated our commitment and determination to address the needs of patients by delivering innovative drugs continuously and efficiently. The two companies will continue to expand commercial collaboration to unleash the product's social value and commercial value faster to benefit patients by leveraging its superiority in treating prostate cancer and 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.

###

About Breast Cancer

Breast cancer is the most common cancer in women worldwide and the number one malignancy threatening women's health worldwide. In 2020, globally there were more than 2 million patients with breast cancer and nearly 685,000 people died from it¹. In China, nearly 420,000 women were diagnosed with breast cancer² and 120,000 women died from it in 2020, accounting for approximately 18% of the global breast cancer deaths¹.

In clinical practice, breast cancer is normally categorized into four subtypes: Luminal A, Luminal B, HER2-positive, and triple-negative⁵. Among them, Luminal A and Luminal B are the hormone receptor-positive subtypes, and their onset and prognosis are highly correlated with estrogen, which account for about 70% of all breast cancer cases⁶. Ovarian function suppression (OFS) is a hormone therapy (Endocrine therapy) to inhibit the generation of estrogen by the ovary through surgery or drug means, which is a cornerstone method for treating premenopausal hormone receptor-positive breast cancer. OFS treatments represented by Gonadotropin-releasing hormone analogs (GnRHa) can inhibit the secretion of the follicle-stimulating hormone and the luteinizing hormone, causing the estrogen levels of pre-menopausal women to reach postmenopausal levels. This can inhibit estrogen-related tumor growth while keeping ovarian function in a state of reversible inhibition⁷.

The Chinese Expert Consensus on the Clinical Application of Ovarian Function Suppression in Early-Stage Breast Cancer (2021) recommends gonadotropin-releasing hormone (GnRH) agonists as the OFS treatments of choice for early-stage hormone receptor-positive breast cancer in premenopausal women. Furthermore, the use of OFS drugs to protect ovarian function and reduce fertility impairment is recommended for premenopausal breast cancer patients no matter they are hormone receptor-positive or negative, both before and during chemotherapy .

About Baituowei (Goserelin Microspheres for Injection)

Developed by Luye Pharma Group, Baituowei (Goserelin Microspheres for Injection) is designated as a "Class 2.2 new chemical drug" in China and has been approved for launch to treat prostate cancer patients requiring androgen deprivation therapy as well as premenopausal and perimenopausal women with breast cancer that can be treated with hormones. Baituowei 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.

In December 2022, Luye Pharma and BeiGene formed a partnership for the commercialization of Baituowei. The latter is granted the exclusive research, development and commercialization rights for the product in Mainland China, and Luye Pharma as the product's Marketing Authorization Holder (MAH) manufactures and supplies the product based on the demand forecast by BeiGene.

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

About BeiGene

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 10,000 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.

----

references：

1. Cao, Wei; Chen, Hong-Da; Yu, Yi-Wen; Li, Ni; Chen, Wan-Qing. Changing profiles of cancer burden worldwide and in China: a secondary analysis of the global cancer statistics 2020. Chinese Medical Journal 134(7):p 783-791, April 5, 2021.
2. Analysis of the disease burden of breast cancer in Chinese women from 1990 to 2017, Liu Wei, Wang Lijun, Qi Jinlei, et al. Chinese Journal of Epidemiology, 2021, 42 (7): 1225-1230. doi: 10.3760/cma.j.cn112338-20200908-01139.
3. JIANG Xiaoting, LIU Qiang, SONG Erwei. Findings and thoughts on the diagnosis and treatment of young patients with breast cancer in China [J]. Chinese Medical Journal, 2022, 102(36) : 2823-2827. DOI: 10.3760/cma.j.cn112137-20220708-01512.
4. Expert consensus on the diagnosis and treatment of young patients with breast cancer in China (2022)
5. JIANG Si-Yuan, SONG Li-Ping, YU Shi-Bo, et al. Relationship between molecular typing and local recurrence, distant metastasis and prognosis of breast cancer patients after modified radical surgery [J]. Cancer Research and Clinics, 2021, 33(6): 408-413. DOI: 10.3760/cma.j.cn115355-20200806-00439.
6. Expert consensus on the diagnosis and treatment of young patients with breast cancer in China (2022)
7. Xiaolin, Yu Yang, Zong Xiangyun. Application and prospect of gonadotropin-releasing hormone analogs in the treatment of breast cancer, 2019