Kintor Pharma Announces China NMPA Approves Clinical Trial of ALK-1 and Nivolumab Combination Therapy for the First-line Treatment of Advanced Hepatocellular Carcinoma

SUZHOU,China,Oct.11,2021 -- Kintor Pharmaceutical Limited ("Kintor Pharma",HKEX: 9939),a clinical-stage biotechnology company developing innovative small molecule and biological therapeutics,announced today that the clinical trial of ALK-1 antibody (GT90001C) and Nivolumab (Opdivo®) combination therapy for the treatment of systemic therapy naïve patients with advanced hepatocellular carcinoma ("HCC") was approved by the National Medical Products Administration (the"NMPA") of China on October 9,2021.

ALK-1 antibody is a fully human IgG2 neutralizing monoclonal antibody that inhibits ALK-1/TGF-β signal transduction and tumor angiogenesis.Kintor Pharmaobtained an exclusive global license for all oncological applications forALK-1 antibodyfrom Pfizer,Inc.,in February 2018.

Thephase II clinical trial of the combination therapy of ALK-1 antibodyand Nivolumab on patients with advanced HCC has started on May 7,2019 in Taiwan,China("Taiwan phase II clinical trial"),evaluated the efficacy and safety of ALK-1 antibody in combination with Nivolumab in patients with advanced HCC who were progressed on or intolerant to first-line therapy with Sorafenib or Lenvatinib.The preliminary data of the ongoing Taiwan phase II clinical trial was released at the ASCO GI 2021 (held between January 15 – 17,2021),and showed positive efficacy and safety results. The overall response rate ("ORR") was 40%.

On 11 February 2021,the investigational new drug application of multiregional phase II clinical trial of combination therapy of ALK-1antibodyand Nivolumab for the second-line treatment of advanced HCC was greenlightedby the United States Food and Drug Administration.

Dr. Youzhi Tong,founder,Chairman and CEO of Kintor Pharma,commented,"Liver cancer has been ranked no. 4 in terms of incident rate and no. 2 in terms of mortality rate in China,and HCC accounts for 75-85% of liver cancer. ALK-1 antibody was in-licensed from Pfizer,which has made Kintor the leader in the clinical development of this anti-cancer angiogenesis inhibitor with the first-in-class potential globally. ALK-1 antibody,in combination with Nivolumab,has demonstrated very positive results in the clinical trial of treating HCC patients who failed sorafenib or Lenvatinib. Currently we are in co-development with Alphamab to test ALK-1's combo therapy with KN046 bispecific for treating a bunch of solid tumors including HCC. NMPA's formal approval of ALK-1 antibody in combination with Nivolumab as the first-line treatment of HCC,which provides a great opportunity for this combo therapy as a potential standard of care for HCC. If successful,the market prospect and commercial value are very promising."

About Kintor Pharmaceutical Limited

Kintor Pharmaceutical Limited is developing and commercializing a robust pipeline of innovative small molecule and biological therapeutics for androgen-receptor-related disease areas with unmet medical needs,including COVID-19,prostate,breast and liver cancer,alopecia and acne. For more information,visit www.kintor.com.cn.