Fochon Pharmaceuticals Doses First Patient in the US in Phase I Clinical Study of FCN-437, a CDK4/6 Inhibitor for Advanced Solid Tumors

Fochon Pharmaceuticals, Ltd. (Fochon), a pharmaceutical company based in the San Francisco Bay Area, Chongqing and Shanghai focusing on R&D of small-molecule drugs, announced June 25, 2019 dosing of the first patient in the US in the recently initiated Phase I clinical trials of FCN-437 in patients with advanced solid tumors.

“This is a truly remarkable moment for both Fochon and oncology patients around the world”, said Dr. Weibo Wang, Co-Founder and CEO of Fochon. “We are tremendously excited to advance our novel and potent CDK4/6 inhibitor —— FCN-437 into the US trial for advanced solid tumors and see if it will deliver the expected benefits to patients.  Congratulations to the team for this very significant step forward in the program.”

About FCN-437

FCN-437 is a novel, proprietary and orally active inhibitor of Cyclin Dependent Kinase 4 and 6 (CDK4/6) developed by Fochon to treat solid tumors. FCN-437 demonstrated much higher in vitro and in vivo potency and selectively inhibitory activities against CDK4/6 compared to approved CDK4/6 inhibitors. FCN-437 exhibited broad anti-tumor activity in preclinical pharmacology models, favorable physical and pharmacokinetic properties, and improved toxicity profile in non-clinical studies. In particular, FCN-437 can distribute to the brain and provide an opportunity to treat tumors that have metastasized to the brain. Preclinical data of FCN-437 was presented by Fochon at 2019 AACR Annual meeting at Atlanta, USA.

Phase I clinical trials of FCN-437 is on-going in China in parallel with the US trial as Fochon also received the approval from China NMPA for the IND application of FCN-437 to treat patients with solid tumors.

CDK4/6 and solid tumors

CDK4/6 can form complex with Cyclin D to phosphorylate Retinoblastoma protein (Rb), which enables cell cycle progression. Phosphorylation of Rb leads to dissociation of Rb from the E2F family of transcription factors and allows transcription of E2F target genes progression that drives cell cycle transition from G1 to the S phase. Loss of cell cycle control caused by aberrations in the CDK/Rb signaling pathway are common in a variety of solid tumors. Inhibiting CDK4/6 blocks CDK/Rb signaling pathway, which prevents cell cycle progression through the G1 restriction point, thus arresting tumor cell growth.

About Fochon

Fochon Pharmaceuticals, Ltd. is a pharmaceutical company focusing on research and development (R&D) of small-molecule drugs for advancing best-in-class therapies to improve human lives.  We are based in the San Francisco Bay Area, Chongqing and Shanghai, with strong financial backing by Shanghai Fosun Pharmaceutical (Group) Co., Ltd. Fochon has a proven track record of accelerating the discovery of best-in-class potential small-molecule therapeutics to clinical development for cancer and metabolic diseases. Since its foundation, Fochon has built a significant R&D pipeline consist of drug candidates targeting ALK/ROS1, BCL-2, BTK, pan-TRK (1st & 2nd generation), CDK4/6, MEK, pan-HER, PI3Kdelta, URAT, DPP-4 and etc., of which FCN-005 (Fotagliptin, DPP-4 inhibitor) in Phase II/III is the most advanced.


Fochon Pharmaceuticals Receives CFDA Approval for Clinical Trials of Innovative Medicine to Treat Solid Tumors

Fochon Pharmaceuticals Receives CFDA Approval for Clinical Trials of Innovative Medicine to Treat Solid Tumors

Fochon Pharmaceuticals receives CFDA approval for clinical trials of the innovative drug FCN-437 capsule, which is intended to treat solid tumors.

Until December 2017, Fochon receives the investment with approximately RMB 28 million on R&D for FCN-437.

Until January 23th, 2018, there is no medicine with independent intellectual property right launched in China (excluding Hong Kong, Macau and Taiwan) with the same targeted therapy as FCN-437.

In 2016, the global sales of similar medicine amounted to about $2.1 billion.