赛生药业控股有限公司 SciClone Pharmaceuticals (Holdings) Limited

[21st July 2021, Hong Kong, China] "Chinese Clinical Practice Guidelines for Transarterial Chemoembolization (TACE) Treatment of Hepatocellular Carcinoma (2021 Edition)” (hereinafter referred to as "the 2021 Guidelines") was officially released at the 2021 Annual Conference of Interventional Doctors of Chinese Medical Doctor Association. Thymalfasin represented by the original product "Zadaxin" from SciClone Pharmaceuticals (Holdings) Limited (“SciClone” or “Company”, collectively referred to as "Group" together with its subsidiaries, stock code: 6600.HK) is included in the sections about TACE combined immunotherapy and perioperative adjuvant medication in the 2021 Guidelines.

Primary hepatic carcinoma mainly includes three pathological types: hepatocellular carcinoma (HCC, hereinafter referred to as “hepatic carcinoma”), cholangiocarcinoma (CC), and the mixed type, where HCC accounts for 85% to 90%. According to epidemiological data[1],^[1]，the annual incidence of hepatic carcinoma in China is about 0.37 million patients. The annual death toll is about 326,000, ranking fourth (26.92/100,000) and second (23.72/100,000) in the malignant tumors in China, respectively. Most patients have been in the middle and late stages when diagnosed, and the median survival of conventional treatments is only about 10 months. Therefore, it is critical for the improvement of overall survival of hepatic carcinoma to seek new effective treatment methods and adopt reasonable multidisciplinary comprehensive treatment strategies to effectively treat middle and advanced hepatic carcinoma. TACE is recognized as one of the most commonly used local therapies for hepatic carcinoma.

In order to further standardize the interventional diagnosis and treatment of hepatic carcinoma in China, the Interventional Physician Branch of Chinese Medical Doctor Association led by Professor Teng Gaojun organized national multidisciplinary experts in hepatic carcinoma intervention and related fields revised and updated to form the 2021 Guidelines based on the 2018 version.

Thymalfasin represented by the original product from SciClone Pharmaceuticals, "Zadaxin", has been recommended for use in both the 2018 and 2021 Guidelines. In the 2021 Guidelines, it is mentioned in the sections "TACE Combined Immunotherapy" and "Postoperative Adjuvant Medication" that thymosin-α1 (that is, thymalfasin) has the "potential value of synergizing with the TACE therapy for hepatic carcinoma"; "As an immunomodulator, it can enhance the responsiveness of the immune system, improve the quality of life of patients, and speed up postoperative recovery after TACE." The launch of the 2021 Guidelines further affirms the status of Zadaxin in the field of hepatic carcinoma treatment and enriches the clinical treatment methods for hepatic carcinoma.

It is worth mentioning that multiple existing clinical studies have confirmed that Zadaxin combined with other therapies can enhance the immune functions of tumor patients,^[2,3,4,5,6]，prolong their survival, reduce relapses, and improve the quality of life. The 2021 Consensus on Guidelines for Lymphoma in China, 2020 Guidelines for Comprehensive Diagnosis and Treatment of Pancreatic Cancer in China, “2020 Guidelines for Diagnosis and Treatment of Primary Hepatic Carcinoma” of CSCO, “2019 Practices for Diagnosis and Treatment of Primary Hepatic Carcinoma” of National Health Commission, “2019 Guidelines for Diagnosis and Treatment of Pancreatic Cancer” of CSCO, and other guidelines have all made relevant recommendations for Zadaxin. In addition, Zadaxin is also included in the “Diagnosis and Treatment Schemes for Severe and Critical Cases of COVID-19 (Trial Version 2)” of the National Health Commission and the first expert consensus in the field of sepsis immunosuppression in China, the "Expert Consensus on Sepsis Immunosuppression Diagnosis and Treatment".

References

1. China Cancer 2019, Vol. 28, P1

2. 2.Linye H, Zijing X, et. Medicine (Baltimore). 2021 May 21;100(20): e25749.

3. 3.Chin J Gen Surg, 2006,21(3):229-230.

4. He C, et al. Medicine (Baltimore). 2017 Apr;96(16):e6606

5. 5.Chinese Journal of Metastatic Cancer, 2020,03(01):30-34.

6. 6.Chin J Gastroenter Hepatol, 2016, 25(7): 787-790

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Thymalfasin Included in "Chinese Clinical Practice Guidelines for Transarterial Chemoembolization (TACE) Treatment of Hepatocellular Carcinoma (2021 Edition)”