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

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 Pharma obtained an exclusive global license for all oncological applications for ALK-1 antibody from Pfizer, Inc., in February 2018.

The phase II clinical trial of the combination therapy of ALK-1 antibody and Nivolumab on patients with advanced HCC has started on May 7, 2019 in Taiwan, China, China ("Taiwan, China 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, China 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-1 antibody and Nivolumab for the second-line treatment of advanced HCC was greenlighted by 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.

Source: Kintor Pharmaceuticals