Recently, Kangfang Biotechnology (9926. HK) announced the completion of the first patient enrollment in a randomized, controlled, multicenter, registered Phase III clinical trial (HARMONI-GI-01/AK112-309) of its independently developed PD-1/VEGF bispecific antibody combination regimen with Ivexil and a comparison with Valiumab (PD-L1) combination regimen for first-line treatment of advanced biliary malignancies (BTC).

Research on AK112-309

The HARMONI-GI-01/AK112-309 study was conducted by renowned domestic liver and gallbladder tumor experts, Professor Zhou Jian from Zhongshan Hospital affiliated with Fudan University and Professor Zheng Tongsen from Harbin Medical University Cancer Hospital, as co principal investigators. The endpoint of the study was overall survival (OS).

The HARMONI-GI-01/AK112-309 study is the sixth registered phase III clinical trial conducted by Ecovaci, using PD-1/L1 monoclonal antibodies as control drugs. It reflects the company's determination and confidence in iterating the current tumor immunotherapy landscape and establishing better global cancer standard treatments. It also demonstrates the ability of Kangfang Biotech to fully explore the clinical and commercial value of its product portfolio through scientific clinical layout.

Previously, the excellent results of a phase II clinical study on the first-line treatment of advanced BTC with Ivosi combined with chemotherapy were published at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. The research results show that the Ivo Western case has significant anti-tumor activity and good safety.

The objective response rate (ORR) was 63.6%, with an ORR of 77.8% for gallbladder cancer patients. The disease control rate (DCR) is 100%.

The median progression free survival (PFS) was 8.5 months, and the 6-month PFS rate was 84.4%.

The median overall survival (OS) was 16.8 months, with a 9-month OS rate of 81.8%; The median OS of gallbladder cancer patients was 16.8 months.

As of this analysis, the median follow-up time was 13.8 months. The median age of enrolled patients was 65.3 years, and 81.8% of patients had an ECOG score of 1. All patients were initially in an unresectable state, with 40.9% of patients having gallbladder cancer.

Biliary malignant tumors are a highly heterogeneous group of malignant tumors originating from the bile duct and gallbladder, with poor prognosis. 50% of patients with biliary malignant tumors are already in the advanced stage at the time of diagnosis, with a survival period of less than 1 year. Although PD-1/L1 inhibitors combined with chemotherapy have been approved as the first-line treatment for advanced biliary tract cancer, the overall survival benefits are still limited, especially for patients with gallbladder cancer. Ecovacil combined with chemotherapy is a potentially superior first-line treatment for advanced BTC, with high potential clinical prospects.

About Yida Fang ®

(PD-1/VEGF dual antibody, Ecovacil)

Yida Fang ® Yiwu Xidan Anti Injection is a PD-1/VEGF bispecific tumor immunotherapy drug independently developed by Kangfang Biotechnology and the world's first. Yida Fang ® Approved by the China National Medical Products Administration in May 2024, it is used for the treatment of locally advanced or metastatic nsq NSCLC with EGFR-TKI, becoming the world's first bispecific antibody drug with a synergistic anti-tumor mechanism of "tumor immunity+anti angiogenesis" approved for market.

At present, the phase III study of the first-line treatment of advanced NSCLC with PD-L1 expression using Ivoxidan compared to pembrolizumab monotherapy has achieved the primary endpoint of progression free survival in mid-term analysis, obtaining a decisive positive result. Based on this study, the first-line treatment of advanced NSCLC with PD-L1 expression positive using Ivoxidan has been submitted to sNDA and given priority review. At the same time, a phase III clinical study comparing the combination of ezetimibe and chemotherapy with trastuzumab for first-line treatment of SQ-NSCLC is underway. The international multicenter phase III clinical study (HARMONI study) led by partner Summit on the combination of ezetimibe and chemotherapy for EGFR mutant, locally advanced, or metastatic NSQ NSCLC undergoing third-generation EGFR-TKI treatment and the international multicenter phase III study comparing the combination of ezetimibe and chemotherapy with pembrolizumab for first-line treatment of SQ-NSCLC are also underway.

In addition, Evoxi has launched three new phase III clinical studies, including the first-line treatment of PD-L1 positive head and neck squamous cell carcinoma (vs Pabolizumab) with Evoxi combined with Lefaride (CD47), the first-line treatment of pancreatic cancer with Evoxi combined with Lefaride, and the first-line treatment of biliary cancer with Evoxi combined with Duvalizumab (vs Duvalizumab combined with Duvalizumab). In general, Evosi is conducting 25+clinical trials in 17 indication fields including lung cancer, pancreatic cancer, breast cancer, hepatocellular carcinoma, colorectal cancer, etc. through single drug and combined drug use.

About Kangfang Biotechnology

Kangfang Biotechnology (9926. HK) is a leading enterprise that integrates research, development, production, and commercialization of the world's first or best in class innovative biopharmaceuticals. Since its establishment in 2012, the company has built a unique end-to-end Kangfang comprehensive new drug research and development platform (ACE Platform), established a research and innovation system centered on Tetrabody bispecific antibody development technology, antibody conjugation (ADC) technology, mRNA technology, and cell therapy technology, an international standard GMP production system, and an advanced commercial system of operation mode, becoming a competitive biopharmaceutical innovation company worldwide.

The company has developed over 50 innovative candidate drugs for the treatment of major diseases such as tumors, autoimmune diseases, inflammation, and metabolic disorders. 22 candidate drugs have entered clinical trials (including 11 bispecific/polyclonal/bispecific ADCs), 5 new drugs have been commercialized, and the marketing applications for 4 new drugs and 5 indications are currently under review and approval.

In August 2021, the company independently developed a differentiated PD-1 monoclonal antibody, Annik ® Approved for listing; In June 2022, the company launched the world's first PD-1/CTLA-4 dual antibody ketamine ® Approved for market launch, becoming the world's first approved dual antibody new drug for tumor immunotherapy, and also the first bispecific antibody new drug in China. In the first half of 2024, Kaitani ® The application for new drug marketing authorization (sNDA) for first-line treatment of advanced cervical cancer has been accepted, and Kaitanib is available ® The combination therapy for first-line treatment of advanced gastric cancer was approved for marketing in September of the same year. In May 2024, the company launched another world first dual antibody new drug, Yida Fang ® Approved for marketing by the China National Medical Products Administration for locally advanced or metastatic nsq NSCLC treated with EGFR-TKI, Yida Fang ® Becoming the world's first approved "tumor immunity+anti angiogenesis" mechanism dual anti drug. During the same period, significant positive results were obtained for first-line treatment of PD-L1 positive NSCLC compared to pembrolizumab, and sNDA with the same indication was accepted by CDE and given priority review. Yiwoxi has become the only drug in the world that has been proven to be significantly more effective than the "drug king" pembrolizumab in head to head phase III clinical trials, and is expected to become a new standard treatment for first-line lung cancer, providing patients with a new and better "chemotherapy free" option. Previously, in December 2022, the company granted external licenses to Yida Fang ® Partial overseas rights and a cooperation plan of 5 billion US dollars+sales commission set a record for the highest transaction amount of Chinese single drug foreign licensing at that time. In September 2024, the company independently developed Yixining ® (Inuximab, PCSK9) has been approved for two indications in the treatment of hypercholesterolemia, becoming the first approved product in the non tumor field.