Fochon Pharmaceuticals, Ltd. (a Subsidiary of Fosun Pharma) Announces Licensing Agreement with Eli Lilly and Company for Novel Selective BCL-2 Inhibitor

(29 October 2020, Shanghai) Fochon Pharmaceuticals, Ltd. (“Fochon”), a subsidiary of Shanghai Fosun Pharmaceutical Co., Ltd. (“Fosun Pharma”, Stock code: 600196.SH, 02196.HK) announced a licensing agreement with Eli Lilly and Company (“Lilly”) today for FCN-338, a selective small-molecule BCL-2 inhibitor targeting hematological malignancies. Lilly will obtain exclusive rights to develop and commercialize FCN-338 in all countries and regions excluding Mainland China, Macao SAR, and Hong Kong SAR. Fochon reserves all right to research, develop, register, manufacture, and commercialize FCN-338 in Mainland China, Macao SAR, and Hong Kong SAR. Each company will be responsible for clinical development, regulatory activities, manufacturing and commercialization in their respective regions.

 “Fochon is committed to developing innovative therapeutics to improve people’s health and lives. FCN-338 has the potential to become an improved option for cancer patients as a potent and selective inhibitor of BCL-2, a key target in anti-apoptotic pathways,” said Weibo Wang, PhD, co-founder and CEO of Fochon. “Our team is glad to reach an agreement with Lilly, whose strong clinical development team could expedite market approval for FCN-338 to help patients worldwide. The agreement underscores Fochon’s unique technical expertise and furthers its ability to continue addressing important unmet medical needs, such as solid tumors and hematological malignancies.”

Under the terms of the agreement, Lilly will pay Fochon an upfront payment of $40 million and up to $400 million in potential development and commercial milestones, as well as mid-to-high single-digit royalty payments on net sales in the Lilly territories.

Yifang Wu, Chairman and CEO of Fosun Pharma and Board Chairman of Fochon: “We are pleased to reach an agreement with Lilly, a world-leading pharmaceutical company, to accelerate the global development of FCN-338 and increase its potential to reach more patients worldwide.”

“BCL-2 is an increasingly important therapeutic target in cancer biology and FCN-338 has the potential to create significant clinical value for patients and strategic value for our portfolio,” said Jacob Van Naarden, Chief Operating Officer of Loxo Oncology at Lilly. “We plan to initiate the Phase 1 trial in the U.S. in the coming months and look forward to generating human pharmacology data, as well as combining the agent with other molecules in the portfolio, starting with LOXO-305.”

About BCL-2 and FCN-338
FCN-338 is a selective inhibitor of B-cell lymphoma-2 (BCL-2). The BCL-2 family of proteins plays an important role in apoptosis, which is the normal process of cell death. FCN-338 is being initially developed for the treatment of hematological malignancies. 

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 at various clinical development stages targeting ALK/ROS1, BCL-2, BTK, pan-TRK (1st & 2nd generation), CDK4/6, MEK, PI3Kdelta, pan-HER, URAT and DPP-4. Please visit http://www.fochon.com for more information.

About Fosun Pharma
Founded in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd is a leading healthcare group in China. Fosun Pharma has built a strong root in China and developed a global operation strategy, with pharmaceutical manufacturing and R&D being the largest and core business segment, together with strong presences in medical devices and diagnostics, healthcare services, pharmaceutical distribution, and retail. 

With R&D innovation as core driving factor, Fosun Pharma continues to optimize its pharmaceutical operations across both innovative and generic drugs. The company has established international R&D centers for excellence in areas such as innovative small molecule drugs, high-value generic drugs, biologics, and cell-therapy.

Under guidance of our 4IN strategy (Innovation, Internationalization, Integration and Intelligentization), Fosun Pharma follows the brand concept of Innovation for Good Health and strives to be a leading enterprise in the global pharmaceutical and healthcare markets.
For more information, please visit: www.fosunpharma.com

About Loxo Oncology at Lilly 
Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. Loxo Oncology at Lilly brings together the focus and spirit of a biotech with the scale and resources of large pharma, with the goal of rapidly delivering impactful new medicines for people with cancer. Our approach centers on creating new oncology medicines that unequivocally work early in clinical development and will matter to patients.

About Eli Lilly and Company 
Lilly is a global healthcare leader that unites caring with discovery to create medicines that make life better for people around the world. Lilly was founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today Lilly remains true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit www.lilly.com.

Lilly Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about the benefits of the license agreement between Lilly and Fochon and reflects Lilly's current beliefs. However, as with any such undertaking, there are substantial risks and uncertainties in the process of drug development and commercialization. Among other things, there can be no guarantee that Lilly will realize the expected benefits of the license agreement, or that the license agreement will yield commercially successful products. For a further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, please see Lilly's most recent Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.


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.