Genting Shin Yao announced that ® Trodelvy® has been approved in China for the second-line treatment of metastatic triple-negative breast cancer

Trodelvy®, the world's first and only approved ADC drug ® targeting Trop-2, was approved in China, becoming the first product of Genting Sun Yao to be marketed in China

Genting Sun Yao plans to launch Tondawi's sales in China in the fourth quarter of this year

The Company will hold a conference call regarding the approval of Todavision

SHANGHAI 10 Jun 2022 /PRNewswire/ -- HKEX 1952.HK, a biopharmaceutical company focused on the development and commercialization of innovative medicines dedicated to meeting the unmet medical needs of the Asian market, today announced that the State Drug Administration of China (NMPA) has approved Tuodawi ® (Trodelvy, A. Trodelvy ®, China). gosartozumab) is used in adult patients with unresectable locally advanced or metastatic triple-negative breast cancer who have previously received at least 2 systemic therapies, of which at least one is for metastatic disease. This is genting Xinyao's first innovative drug approved for marketing in China, and the State Drug Administration accepted its application for marketing authorization for biological products in May 2021 and granted priority review.

Dr Kerui Bo, CHIEF Executive Officer of Genting Sun Yao, said: "Tondawi ® is the world's first and only approved ADC drug targeting Trop-2, and we are very excited to have it approved in China. This is our first product to be approved at home in China, marking a new and important milestone achieved by Genting Sun Yao. We will continue to bring innovative therapies to people with urgent medical needs. We would also like to thank the State Drug Administration and the National Drug Review Center for priority review and expedited approval. ”

Shi Yang, Chief Medical Officer of The Cancer/Immunology Field at Genting Xinyao, said: "Triple negative breast cancer is a highly invasive and currently difficult to treat disease, and the approval of Tuodawi ® by the State Drug Administration will provide an innovative and important treatment option for Chinese women with metastatic triple negative breast cancer. We would like to thank all the researchers and patients involved in clinical trials who made this possible. We will continue to work with our partner Gilead to advance follow-up clinical studies in Topavi ® for multiple tumor types as well as more frontline treatments." ”

In November 2021, Genting ShinYao published the top-line results of the Gosartozumab Phase 2b EVER-132-001 study, which reached its primary endpoint with an objective response rate (ORR) of 38.8%. The study, conducted in 80 patients in China, yielded results consistent with the results of the global Phase 3 ASCENT study and therefore showed similar efficacy and safety in Chinese populations.

Professor Xu Binghe, academician of the Chinese Academy of Engineering, director of the National New Drug (Anti-tumor) Clinical Research Center, and the main investigator of the Tuodawei China Registered Research, said: "Patients with triple negative breast cancer are in urgent need of new and effective treatment protocols. I witnessed the introduction of gosartuzumab, or totavir, into China and led a registered clinical study in China. We are very happy that gosartolizumab has shown good therapeutic results in domestic clinical studies as well as internationally, and as clinicians, we look forward to the early application of this new drug to the clinic and save the lives of more patients." ”

Guo Yong, Chief Commercial Officer of Genting Sun Yao, said: "In China, there is a large unmet need for metastatic triple-negative breast cancer patients, who urgently need better treatment options to prolong their lives. With the approval of Tuodawei ® in China, we will rapidly expand our academic promotion team and expect to commercially launch this new product in the fourth quarter of this year, bringing it to as many Chinese hospitals and patients as possible." ”

In addition to the approved ® Chinese mainland and Singapore, Genting Shine is working closely with drug regulatory authorities in South Korea, Taiwan and Hong Kong to consider ® applications from Trodelvy ® for the treatment of adult patients with non-resectable locally advanced or metastatic triple-negative breast cancer who have previously received at least two systemic treatments, at least one of which is for metastatic disease.

• In December 2021, The Ministry of Food and Drug Safety (MFDS) of The Republic of Korea accepted Trodelvy's ® new drug listing application. Trodelvy was previously awarded the Rapid Review Process Accreditation and Orphan Drug Qualification in South Korea.
• In December 2021, the Drug Regulatory Authorities of Taiwan accepted Trodelvy's ® new drug listing application. Previously, Trodelvy was qualified for priority review of pediatric or small number of serious disease drugs in Taiwan.
• In January 2022, the Health Sciences Board of Singapore approved Trodelvy's ® new drug application for second- and later treatment of metastatic triple-negative breast cancer.
• In March 2022, Genting Shin Yao submitted a new drug listing application for Trodelvy ® to the Department of Health of the Hong Kong Special Administrative Region of China for the second-line treatment of metastatic triple-negative breast cancer.

Conference Call Information:

The conference call will take place on June 13 at 8:00 a.m. Beijing time (June 12 at 8:00 p.m. EST).

Webcast Link:.

To ask questions, participants can dial the following numbers by phone:

United States:

International:

Chinese mainland:

Hong Kong, China:

Meeting code: 3896851

After the meeting, you can listen to the meeting replay by visiting the Genting Sun Yao official website.

About triple-negative breast cancer ( TNBC ）

Triple-negative breast cancer is a highly aggressive disease, accounting for about 15% of all breast cancer types worldwide. In Asia, the median age of breast cancer diagnosis is younger than in Western countries, and the proportion of molecular subtypes of triple-negative breast cancer has increased year by year in the past 10 years. Triple-negative breast cancer tumors lack adequate estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2). Due to the nature of triple-negative breast cancer, effective treatment options are extremely limited compared to other types of breast cancer. Triple-negative breast cancer has a higher chance of recurrence and metastasis than other types of breast cancer. The average time for metastatic recurrence of triple-negative breast cancer is about 2.6 years, compared with 5 years for other breast cancers, which is even lower than the 5-year survival rate. The 5-year survival rate is 12% in women with metastatic triple-negative breast cancer, compared with 28% in patients with other types of metastatic breast cancer.

About Totawi

®

(Product name in English: Trodelvy

®

, Chinese drug generic name: gosartozumab )

Todawi ® is a first-of-its-kind antibody-coupled drug that targets the Trop-2 receptor, a cell surface antigen that is overexpressed in many types of tumors, including more than 90% of breast and bladder cancers. Topavid has a specific hydrolyzable linker that can be attached to the payload topoisomerase I inhibitor SN-38. This unique design guarantees potent activity in Trop-2-expressing cells and adjacent microenvironments.

Tondavi ® has been approved in more than 35 countries for the treatment of unresectable adult patients with locally advanced or metastatic triple-negative breast cancer (TNBC) who have previously received at least two systemic treatments, at least one of which is for metastatic disease. Tondawi ® is also receiving accelerated approval in the U.S. for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who have previously received platinum-containing chemotherapy and programmed death receptor-1 (PD-1) or programmed death ligand 1 (PD-L1) inhibitors. Tondawi ® is also being developed for use in other populations of TNBC and metastatic UC, as well as a range of tumor types overexpressed Trop-2, including hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer, metastatic non-small cell lung cancer (NSCLC), metastatic small cell lung cancer (SCLC), head and neck cancer, and endometrial cancer.

Under a licensing agreement with Gilead Sciences, Genting Shin Yao enjoys exclusive rights to develop, register and commercialize all cancer indications in ®® Greater China, South Korea and select Southeast Asian countries. In October 2020, it was included in the updated 2020 edition of the Guidelines for the Standardized Diagnosis and Treatment of Advanced Breast Cancer in China. In October 2021, it was included in the "Guidelines and Specifications for the Diagnosis and Treatment of Breast Cancer of the Chinese Anti-Cancer Association (2021)". In April 2022, it was included in the updated "2022 Chinese Society of Clinical Oncology (CSCO) Breast Cancer Diagnosis and Treatment Guidelines". In the same month, it was first included in the "Taiwan Breast Medicine Association Triple Negative Breast Cancer Treatment Consensus Manual (2022 Edition)" updated in Taiwan.

*The TRODELVY trademark is licensed by Gilead Sciences, Inc

About Genting Shin Yao

Genting Sun Yao is a biopharmaceutical company focused on the development and commercialization of innovative medicines, dedicated to meeting the unmet medical needs of the Asian market. Genting Sun Yao's management team has deep expertise and extensive experience in high-quality clinical development, pharmaceutical affairs, chemical manufacturing and control (CMC), business development and operations in leading pharmaceutical companies in China and around the world. Genting Sun Yao has created 11 drug combinations that have the potential to become the world's first-of-its-kind or best-in-class drugs, most of which are already in the advanced stages of clinical trials. The company's therapeutic areas include oncology, autoimmune diseases, cardiovascular and kidney diseases, infectious and infectious diseases. For more information, please visit the company's website: .

Forward-Looking Statements

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