Innovent Biologics and Eli Lilly Announce NMPA Approval of HALPRYZA® (Rituximab Injection) in China

SAN FRANCISCO, U.S. and SUZHOU, China, Oct. 9, 2020 /PRNewswire/ -- Innovent Biologics (HKEX stock code: 01801), a biopharmaceutical company dedicated to the research, development, manufacturing, and commercialization of innovative medicines for the treatment of major diseases such as cancer, metabolic disorders, and autoimmune diseases, today jointly announced with Eli Lilly and Company (NYSE ticker symbol: LLY) that Tyvyt® (sintilimab injection), a recombinant human-mouse chimeric anti-CD20 monoclonal antibody injection co-developed by both parties,^®(Rituximab Injection, English brand name: HALPRYZA^®) officially received marketing approval from the National Medical Products Administration (NMPA) for the treatment of diffuse large B-cell lymphoma, follicular lymphoma, and chronic lymphocytic leukemia. This follows Tyvyt^®(Sintilimab Injection), Dayoutong^®(Bevacizumab Injection), Sulixin^®(adalimumab injection), the fourth monoclonal antibody drug approved for marketing by the NMPA from Innovent Bio. It is also the next after Tyvyt^®Subsequently, the second monoclonal antibody drug jointly developed and launched by Innovent Bio and Eli Lilly and Company.

Multiple large-scale confirmatory clinical trials of rituximab have fully demonstrated its clinical efficacy and safety in CD20-positive non-Hodgkin lymphoma, establishing it as the standard of care for this condition. Since its market launch, the originator rituximab injection has been approved globally for multiple indications, including non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA), and moderate-to-severe adult pemphigus vulgaris (PV). Its significant efficacy and favorable safety profile have been widely recognized. Tyvyt^®(Rituximab Injection) is a recombinant human-mouse chimeric anti-CD20 monoclonal antibody injection co-developed by Innovent Bio and Eli Lilly and Company, known as Tyvyt.^®(The launch of Rituximab Injection) will provide more Chinese patients with high-quality and more affordable Rituximab Injection.

Dr. Zhou Hui, Vice President of the Medical Science and Strategic Oncology Department at Innovent Bio, stated, “As a key achievement of the National Major New Drug Development Program, Tyvyt”^®(Rituximab Injection) is an international-quality anti-CD20 monoclonal antibody, following Tyvyt^®(Sintilimab Injection), Dayoutong^®(Bevacizumab Injection), Sulixin^®the fourth monoclonal antibody drug approved for marketing by Innovent Bio after (adalimumab injection). We also sincerely look forward to Tyvyt^® (Rituximab Injection) is enabling an increasing number of Chinese patients to benefit. With this milestone, Innovent Bio has become the only pharmaceutical company in China with four marketed monoclonal antibody drugs. We will continue our efforts, staying true to our original aspiration of developing high-quality biologics that are affordable for the general public, thereby bringing hope for life to more patients.”

Dr. Li Wang, Senior Vice President of Eli Lilly China and Head of the Drug Development and Medical Affairs Center, stated: “We are delighted to see the strategic collaboration between Eli Lilly and Innovent Bio bearing fruit once again. Lymphoma is one of the malignancies with the fastest-growing incidence rate, while also having a relatively high cure rate. Tyvyt^®“The approval and market launch of (Rituximab Injection) will provide new treatment options for lymphoma patients in China, helping them improve their quality of life and extend their lifespan.”

About Malignant Lymphoma

Malignant lymphoma is the most common hematologic malignancy and one of the top ten cancers with high incidence and mortality rates in China. In recent years, its incidence has shown an upward trend. Based on histopathological changes, lymphomas are classified into two categories: Hodgkin's lymphoma (HL) and non-Hodgkin's lymphoma (NHL), with NHL accounting for the vast majority. NHL is a general term for a group of related but distinct malignant tumors of lymphoid tissue. The majority (80–85%) originate from B cells, while the remainder arise from T cells or natural killer (NK) cells. More than 95% of B-cell non-Hodgkin lymphomas express CD20. Furthermore, the incidence of NHL increases with age. In China, the most common subtype of NHL is diffuse large B-cell lymphoma (DLBCL), which accounts for approximately 40–50% of cases (compared to about 30–40% in Western countries). DLBCL is an aggressive lymphoma ranging from intermediate to high-grade malignancy. It progresses rapidly, and without treatment, patient survival is limited to only a few months.

About Tyvyt® (Rituximab Injection)

Tyvyt®^®As a biosimilar to rituximab injection, also known as recombinant anti-CD20 monoclonal antibody injection, rituximab is a monoclonal antibody that binds to the CD20 antigen on the surface of B lymphocytes, mediating complement-dependent cytotoxicity (CDC) and antibody-dependent cell-mediated cytotoxicity (ADCC), thereby inducing lysis of normal and malignant B cells in vivo to achieve antitumor therapeutic effects.

About Innovent Bio

“Rooted in Trust, Delivered through Action.” Innovent Bio’s vision and goal is to develop high-quality biologics that are affordable to the general public. Established in 2011, Innovent Bio is dedicated to the development, manufacturing, and commercialization of innovative medicines for the treatment of major diseases, including cancer, metabolic disorders, and autoimmune diseases. On October 31, 2018, Innovent Biologics (Suzhou) Co., Ltd. was listed on the Main Board of The Stock Exchange of Hong Kong Limited, with the stock code: 01801.

Since its establishment, the company has stood out among numerous biopharmaceutical companies by virtue of its innovative achievements and internationalized operational model. It has established a product pipeline comprising 23 new drug candidates, covering multiple disease areas including oncology, metabolic diseases, and autoimmune disorders. Among these, six candidates have been selected for the National “Major New Drug Creation” Special Project, and four products (Sintilimab Injection, brand name: Tyvyt^®, English trademark: TYVYT^®; Bevacizumab biosimilar, brand name: Byvasda^®, English trademark: BYVASDA^®；Adalimumab Biosimilar, Brand Name: Sulixin^®, English Trademark: SULINNO^®; Rituximab biosimilar, brand name: Halpryz^®, English trademark: HALPRYZA^®) received NMPA approval for market launch; four candidates have entered Phase III or pivotal clinical studies, and an additional 15 products have either entered or are poised to enter clinical development. Sintilimab was successfully included in the National Reimbursement Drug List (NRDL) in November 2019, becoming the only PD-1 inhibitor incorporated into the updated NRDL.

Innovent Bio has assembled a high-caliber team for the development and industrialization of biopharmaceuticals, featuring international advanced expertise and numerous overseas-returning experts. The company has established strategic collaborations with international partners including Eli Lilly and Company, Adimab, Incyte, MD Anderson Cancer Center, and Hanmi Pharmaceutical. Innovent Bio is committed to working collectively to elevate the development level of China’s biopharmaceutical industry, thereby enhancing drug accessibility for the public and fulfilling people’s aspirations for better health and well-being. For more details, please visit the company’s website:www.innoventbio.com。

About Eli Lilly and Company

Eli Lilly and Company is a global leader in the pharmaceutical industry, dedicated to improving human health through innovation. Founded more than a century ago, the company was established with a commitment to producing high-quality medicines that meet real medical needs. Today, we remain steadfast in this mission and guide our work by it. Worldwide, our employees strive to discover and develop life-changing medicines and deliver them to patients who truly need them. Furthermore, we are committed to enhancing public understanding of diseases and improving disease management, while giving back to society through philanthropy and volunteerism. For more information about Eli Lilly and Company, please visit:www.lilly.com。

Strategic Collaboration Between Innovent Bio and Eli Lilly

Eli Lilly and Innovent Bio entered into a biopharmaceutical development collaboration in March 2015, which remains one of the largest partnerships to date between a Chinese biopharmaceutical company and a multinational pharmaceutical corporation. Under the terms of the agreement, Eli Lilly and Innovent Bio jointly develop and commercialize oncology drugs in China, including Tyvyt® (sintilimab injection). In October 2015, the two parties announced an expansion of their established drug development collaboration by adding three novel oncology therapeutic antibodies. In August 2019, the partnership was extended into the field of diabetes, with Innovent Bio obtaining authorization to develop and commercialize in China a potential global best-in-class novel clinical-stage diabetes drug from Eli Lilly. In August 2020, Innovent Bio granted Eli Lilly exclusive licensing rights for sintilimab outside of China. These four collaborations with Eli Lilly signify that Innovent Bio has established a comprehensive strategic partnership between a Chinese innovative pharmaceutical enterprise and a global pharmaceutical giant, encompassing new drug research and development, clinical studies, manufacturing quality, and marketing and sales.