September 15, 2021 (Shanghai, China) - Jiangsu Hengrui Pharmaceuticals Co., Ltd. announced that the China National Medical Products Administration (NMPA) recently approved two IND applications for SHR-1701, enabling the following two trials to be initiated.

1. A Phase II/III study in combination with S-1 (tegafur-gimeracil-oteracil potassium) and oxaliplatin as the perioperative treatment of resectable gastric cancer or gastroesophageal junction cancer

2. A Phase III study in combination with BP-102 (Hengrui’s bevacizumab biosimilar) as the first-line treatment of persistent, recurrent, or metastatic cervical cancer

About SHR-1701

SHR-1701 is an investigational bifunctional fusion protein composed of a human IgG4 monoclonal antibody against PD-L1 fused to the extracellular domain of TGF-β receptor II, designed to simultaneously block the two immunosuppressive signaling pathways. The blockade of TGF-β pathway may enhance the tumor response to anti-PD-1/PD-L1 antibodies.

SHR-1701 is currently being developed as a monotherapy, or in combination with chemotherapy or targeted cancer therapies for the treatment of solid tumors such as lung cancer, pancreatic cancer, cervical cancer, nasopharyngeal cancer, gastric cancer, and head and neck squamous cell carcinomas.

The preliminary data from two Phase I trials demonstrated compelling efficacy and safety of SHR-1701. The preliminary results were presented in ASCO 2021 ^{1, 2} and more data will be released in ESMO 2021. Due to the role of TGF-β in metastasis, SHR-1701 may be better suited for the neoadjuvant/adjuvant settings versus anti-PD-1/PD-L1 antibodies.

About Gastric Cancer

Gastric cancer (GC) is a malignant tumor with high prevalence and relatively poor prognosis. According to GLOBOCAN 2020, approximately 1.09 million patients were diagnosed with stomach cancer globally, which was approximately 5.6% of all new cases in 2020. GC mainly occurs in Asia, South America and Africa. With the application of improved surgical techniques and chemotherapy and other technical means, the mortality rate of GC has decreased, but the 5-year survival rate is still poor.³ The average 5-year relative survival rate in western countries is approximately 21.6%-32%.^4,5 The survival rate continues to fall beyond five years after diagnosis.⁴ It is hard to diagnose early-stage gastric cancer due to lack of typical symptoms. GC patients with a known stage are most commonly diagnosed at stage IV (46%-57%) in England, Scotland, and Northern Ireland.⁴ Similarly, patients with advanced GC accounts for a considerable proportion of GC patients in China, which leads to the low 5-year survival rate of 27% in China. Therefore, a better therapeutic regimen is urgently needed to improve the treatment outcome of advanced gastric cancer.

About Cervical Cancer

Cervical cancer is one of the most common types of malignant tumor in women. According to GLOBOCAN 2020, there were approximately 0.6 million new cases of cervical cancer worldwide. The current treatment options are mainly surgery, chemotherapy and radiotherapy, and the efficacy of single immunotherapy is limited. It is urgent to develop more effective therapies, especially for patients who want to maintain fertility. The combination immunotherapies are the trend to treat recurrent and metastatic cervical cancer.

About Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Hengrui is a leading global pharmaceutical company based in China with a focus on research, development, manufacturing and commercialization of innovative and high-quality healthcare products. Innovation is the core development strategy. Hengrui ranked the 21st among the top 1,000 global pharma companies in 2020. Hengrui has been on the Pharma Exec’s annual listing of the top global pharmaceutical companies for the third consecutive year, rising from the 47th in 2019 to the 38th in 2021.

BD Contact

Email: bd@hengrui.com

Phone: +86-21-61053532

1. https://ascopubs.org/doi/abs/10.1200/JCO.2021.39.15_suppl.9055

2. https://ascopubs.org/doi/abs/10.1200/JCO.2021.39.15_suppl.2503

3. Luo M, Li F. Clinical utility of miniprobe endoscopic ultrasonography for prediction of invasion depth of early gastric cancer: A meta-analysis of diagnostic test from PRISMA guideline. Medicine (2019) 98:6.

4. Cancer Research UK, https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/stomach-cancer, accessed September 2021.

5. American Cancer Society, https://www.cancer.org/cancer/stomach-cancer/detection-diagnosis-staging/survival-rates.html, accessed September 2021.