Cerus Corporation (Nasdaq: CERS) and Shandong Zhongbaokang Medical Implements Co. Ltd. (ZBK) today announced that they are forming a joint venture (JV) with the intent to develop, obtain regulatory approval for, manufacture and commercialize the INTERCEPT Blood System for platelets and red blood cells in China. The JV, which will be named “Cerus ZBK Biomedical” (CEZB), will be headquartered in Zibo, Shandong Province in eastern China.
“We are honored to join forces with ZBK in China, furthering our mission to make INTERCEPT the standard of care for patients globally,” said Pascal Maillard, Cerus’ vice president of commercial operations for the Asia Pacific region. “We believe that ZBK’s experience with local clinical and regulatory requirements, ISO-certified manufacturing infrastructure, and existing sales channels will facilitate accelerated and broad access to INTERCEPT across China’s transfusion medicine community.”
China represents one of the largest potential blood transfusion markets globally for INTERCEPT, with red blood cell collections in excess of 23 million unit-equivalents each year, and an estimated production of 1.8 million platelets doses per year. The healthcare system in China continues to grow at a rapid pace, enabling expanded access to blood components expected to benefit from pathogen inactivation.
“We are delighted to collaborate with Cerus to work to bring INTERCEPT to China as the market for platelets continues to grow rapidly,” said Mr. Xu Junfeng, chief executive officer of ZBK. “INTERCEPT-treated platelets would address an unmet clinical need in the blood transfusion market in China and would offer an important new, prospective measure of safety against known and emerging pathogens during this new era of pandemic preparedness planning.”
ZBK is a subsidiary of the Taibao Group and a leading developer, manufacturer and marketer of blood transfusion, blood safety, and infusion products in China. ZBK markets and sells its products through its own sales force network to over 280 blood centers nationwide.
Under the terms of the JV agreement, Cerus and ZBK are the sole shareholders in CEZB, with Cerus owning a majority (51%) of the entity. Cerus anticipates that it will consolidate the results of CEZB in its consolidated financial statements. Additionally, Cerus will contribute an exclusive license to the INTERCEPT Blood System for platelets and red blood cells for CEZB to market across China. ZBK will contribute its significant local expertise to help perform necessary clinical studies and seek regulatory approval. Ultimately it is expected that ZBK will establish local manufacturing and leverage its commercial expertise and presence in the region.
ABOUT SHANDONG ZHONGBAOKANG MEDICAL IMPLEMENTS
Established in 1996, Shandong Zhongbaokang Medical Implements Co., Ltd, the key enterprise of the Taibao Group, is a professional manufacturer specialized in the research, development, production, and sales of blood transfusion equipment whose main products range from Virus Inactivation Plasma Transfusion Filters, Leukocyte Removal Filters, Sterile Infusion Sets with Needles, precision Liquid Medicine Filter, Plasmapheresis Sets and Centrifuge Apparatus, Lightproof Infusion Sets to Needleless Injectors. All of ZBK products comply with international quality standards and are widely used in a variety of different markets throughout the world. For more information about ZBK, visit www.zbkmedical.com.
Cerus Corporation is dedicated solely to safeguarding the world’s blood supply and aims to become the preeminent global blood products company. Headquartered in Concord, California, the company develops and supplies vital technologies and pathogen-protected blood components to blood centers, hospitals, and ultimately patients who rely on safe blood. The INTERCEPT Blood System for platelets and plasma is available globally and remains the only pathogen reduction system with both CE mark and FDA approval for these two blood components. The INTERCEPT red blood cell system is under regulatory review in Europe, and in late-stage clinical development in the US. Also in the US, the INTERCEPT Blood System for Cryoprecipitation is approved for production of Pathogen Reduced Cryoprecipitated Fibrinogen Complex, a therapeutic product for the treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency. For more information about Cerus, visit www.cerus.com and follow us on LinkedIn.
INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus Corporation.
FORWARD LOOKING STATEMENTS
Except for the historical statements contained herein, this press release contains forward-looking statements concerning Cerus’ products, prospects and expected results, including statements relating to Cerus’ joint venture with ZBK and the expected benefits to Cerus thereof; Cerus’ mission to make INTERCEPT the standard of care for patients globally; Cerus’ belief that ZBK’s relevant experience will facilitate accelerated and broad access to INTERCEPT for the Chinese transfusion medicine community; China representing one of the largest potential blood transfusion markets globally for INTERCEPT; INTERCEPT-treated platelets addressing an unmet clinical need in the blood transfusion market in China; Cerus’ expectation that it will consolidate the results of CEZB in its consolidated financial statements; and other statements that are not historical fact. Actual results could differ materially from these forward-looking statements as a result of certain factors, including, without limitation: risks related to Cerus’ ability to maintain its joint venture with ZBK and to achieve its intended benefits; Cerus’ ultimate reliance on ZBK and the joint venture to develop, seek regulatory approval for, and if approved, to market, sell, distribute and maintain the INTERCEPT Blood System for platelets and red blood cells in China; risks related to the uncertain and time-consuming development and regulatory process, including the risks that the INTERCEPT Blood System for platelets and red blood cells may not receive the requisite regulatory approvals to be commercialized in China in a timely manner or at all; risks related to Cerus’ and ZBK’s ability to demonstrate to the transfusion medicine community and other health care constituencies in China and elsewhere that pathogen reduction and the INTERCEPT Blood System is safe, effective and economical; risks related to Cerus’ and ZBK’s ability to maintain compliance with applicable law related to the conduct of their respective businesses and that of the joint venture; risks related to changes in the regulatory landscape relating to conduct of business in foreign jurisdictions, including in China; risks related to adverse market and economic conditions, including continued or more severe adverse fluctuations in foreign exchange rates and/or continued or more severe weakening in economic conditions resulting from the evolving effects of the COVID-19 pandemic or otherwise in the markets where the INTERCEPT Blood System is sold and is anticipated to be sold; the risks that the INTERCEPT Blood System does not inactivate all known pathogens, and the inability of the INTERCEPT Blood System to inactivate certain pathogens may limit its market adoption; risks associated with the ultimate duration and severity of the COVID-19 pandemic and resulting global economic and financial disruptions; the impact of legislative or regulatory healthcare reforms that may make it more difficult and costly for Cerus, ZBK and/or the joint venture to develop, obtain regulatory approval for, produce, market and distribute the INTERCEPT Blood System; risks related to future opportunities and plans, including the uncertainty as to the ultimate success of Cerus’ plans for the INTERCEPT Blood System in China as well as globally, as well as other risks detailed in Cerus’ filings with the Securities and Exchange Commission, including under the heading “Risk Factors” in Exhibit 99.1 to Cerus’ Current Report on Form 8-K, filed with the SEC on December 11, 2020. In addition, to the extent that the COVID-19 pandemic adversely affects Cerus’ business and financial results, it may also have the effect of heightening many of the other risks and uncertainties described above. Cerus disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.