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Aug 30, 2021

Evive Biotech and Sino Biopharm Subsidiary Announce Strategic Collaboration to Commercialize F-627 in China

  • Evive Biotech to out-license novel biologic drug F-627 (efbemalenograstim alfa, long-acting G-CSF) to Chia Tai Tianqing Nanjing Shunxin, the core subsidiary of Sino Biopharm, in China
  • Evive Biotech to receive total upfront and potential milestone payments of up to 210M RMB (est. $33M USD) as well as double-digit royalties on product sales

Beijing CHINA, SINGAPORE– August 30, 2021 — Evive Biotech (Evive) and Chia Tai Tianqing Nanjing Shunxin  (CTTQ-SX), a subsidiary of Sino Biopharm (HKEX: 1177)  today announced an exclusive license agreement for the commercialization of novel biologic drug F-627 (efbemalenograstim alfa, long-acting G-CSF) for the treatment of chemotherapy-induced-neutropenia (CIN) in China. Evive is eligible to receive up to 210M RMB (est. $33M USD) in total upfront and milestone payments along with double-digit royalties on sales of F-627. This partnership marks Evive’s first in a series of global commercial agreements for F-627 which is currently undergoing BLA regulatory review with the US FDA under the brand name Ryzneuta™.

This collaboration will support the commercialization of Evive’s novel biologic F-627 to treat patients at risk of developing CIN in China. CTTQ brings an experienced sales force of over 7,000 academic promotion and commercial representatives covering a network of over 6,000 general hospitals and oncology centers. As a result of the agreement, F-627 is projected to reach annual peak sales of at least 2 B RMB (est. $300M USD) in China. The collaboration also positions Evive and CTTQ to potentially develop and commercialize Evive’s pipeline assets in liver, inflammatory and metabolic diseases in the China market.

“We are excited to be announcing our partnership with CTTQ in China, the first territory in Evive’s global commercialization roadmap for F-627. This important collaboration builds on the strong foundation of F-627’s comprehensive clinical development program that encompassed over 1,200 patients across the US, EU, Australia, and China covering multiple forms of chemotherapy,” said Dr. Jubo Liu, CEO of Evive Biotech. “In China, CTTQ’s market-leading position in oncology and liver diseases makes them the ideal commercial partner to bring F-627 to the market, as well as a long-term partner for our portfolio of clinical stage products targeting liver disease and inflammatory disorders. We look forward to working with CTTQ to accelerate bringing this novel treatment to the many patients in urgent need in China.”

“We are very pleased to have entered into this agreement with Evive, the first company in China to complete global Phase 3 trials and file a completed BLA for an innovative biologic drug to the US FDA,” said Mr. Shanchun Wang, President of CTTQ. “We are excited by the prospect of bringing F-627 to patients in need in China. Chemotherapy-induced neutropenia is a potentially fatal and common complication in patients with cancer treated with chemotherapy. We believe that F-627 has the potential to address China’s tremendous unmet medical need in CIN and look forward to leveraging CTTQ’s commercial strengths to bring this novel product to cancer patients in China.”

Under the terms of the agreement, Evive is eligible to receive total upfront and milestone payments of up to 210M RMB (est. $33M USD) based on achievement of certain development and commercial milestones as well as potential double-digit royalties on commercial sales. Evive and CTTQ will share responsibility and costs for further development in mainland China. Evive will retain exclusive rights for the development and commercialization of F-627 outside of mainland China.

***ENDS***

About F-627

F-627 (efbemalenograstim alfa) is developed for the treatment of chemotherapy-induces neutropenia (CIN) in cancer patients after chemotherapy. Neutropenia is a common side-effect of chemotherapy and is a condition characterized by low levels of neutrophils, a type of white blood cell that fights infection. F-627 is a recombinant fusion protein containing G-CSF at the amino terminal and human IgG2-Fc fragment at the carboxyl terminal. F-627 is expressed in Chinese Hamster Ovary (CHO) cells. F-627 exists as a homodimer with two G-CSF-Fc molecules covalently linked through disulfide bonds formed between the Fc moiety of the molecule. Through specific binding to its receptor, G-CSF receptor, F-627 stimulates survival, proliferation, differentiation, and function of neutrophil precursors and mature neutrophils. F-627 strengthens the immune system’s ability to fight infection by increasing the production of these critical white blood cells, thus preventing potential chemotherapy dose reductions and delays that may compromise treatment outcomes. The F-627 pivotal Phase 3 trial (NCT03252431) is a multi-center, randomized, multi-dose, active-controlled study comparing the efficacy and safety of F-627 and Neulasta®. The trial met its primary and secondary endpoints mutually agreed upon by the FDA and Evive during Special Protocol Assessment (SPA). The results demonstrated the efficacy and safety profile of F-627.

About Evive Biotech

Evive Biotech is a global biologics company with Asian roots, developing a portfolio of novel biological therapies for patients worldwide. We leverage our proprietary technology platforms to advance a series of innovative drug candidates for oncology and inflammatory disorders. Founded in 2004, we have over 270 employees today with operations in the US, Singapore and China. We adopt a holistic approach to drug development, combining exceptional research and commercialization capabilities with world class in-house regulatory expertise to bring innovative therapies to market quickly and efficiently. Through partnerships with industry, physicians, and regulatory authorities, we develop revolutionary remedies that we believe will make a real and lasting difference to patients and their families worldwide.

To learn more about Evive Biotech, visit www.evivebiotech.com.

About Sino Biopharm and CTTQ

Listed on the Hong Kong Stock Exchange in 2000, Sino Biopharm is one of the leading biopharmaceutical companies in China with therapeutic areas spanning across liver disease, oncology, orthopedics, infectious, respiratory, and cardiovascular and cerebrovascular diseases. The company recorded sales exceeding RMB 14.3 billion in first half of 2021, in which liver drugs accounted for 13.9% of its sales. Sino Biopharm was ranked 42nd in “Pharm Exec’s Top 50 Companies 2020”, an annual ranking of global pharmaceutical companies based on its revenue level, in which the company is one of the few Chinese companies that are included on the list. The company was also named one of “Asia 200 Best Over a Billion” in 2019 by Forbes Magazine, representing the only Chinese biopharmaceutical company selected.

Chia Tai Tianqing (CTTQ) Pharmaceutical Group is an innovative pharmaceutical company with integrated R&D, manufacturing, marketing, sales and distribution capabilities. With more than 14,000 employees, CTTQ is the market leader in oncology, liver and respiratory medicines in China, with more than 14,000 employees. It ranks 15th on the list of the “Top 100 Pharmaceutical Enterprises in China” in 2020 and ranks 1st for Chinese pharmaceutical companies with the best drug pipeline in 2021. CTTQ has an integrated academic promotion, professional services and sales network with more than 400 liaison offices or regional offices in large and medium-sized cities across the country, and more than 7,000 academic promotion and commercial sales representatives providing product information dissemination, communication, and feedback services. Scientific innovation is CTTQ’s core strategy for sustainable development. CTTQ actively develops innovative and high-quality drugs within six therapeutic areas of oncology, liver disease, respiratory, infection, endocrine, and cardiovascular and cerebrovascular diseases. CTTQ invests 10-12% of annual sales revenue in R&D every year. There are 196 projects in the product pipeline, including 82 innovative drugs which include 30 major National Key Projects. CTTQ has filed more than 1,500 domestic invention patents, including more than 500 invention patents granted in China and more than 200 invention patents granted abroad.

 

Evive Biotech Media Contact:

media@evivebiotech.com

CTTQ Media Contact:

cttq@cttq.com

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