San Francisco and Suzhou, China, November 28, 2024 /PR Newswire/ -- Innovent Bio (Hong Kong Stock Code: 01801), a biopharmaceutical company dedicated to the research, production, and sale of innovative drugs for the treatment of major diseases such as tumors, autoimmune diseases, metabolic disorders, and ophthalmology, announced: The new drug, Ibetic (Togrolizumab Injection, anti-PCSK9 monoclonal antibody), and the new indication for Nailaike (Aurelaban, BCR-ABL inhibitor) have successfully been included in the revised "National Essential Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Directory (2024)" ("National Medical Insurance Directory"). The new version of the National Medical Insurance Directory will officially implement on January 1, 2025.
This time, Ibetic (Togrolizumab Injection) has been included in the National Medical Insurance Directory for the treatment of primary hypercholesterolemia (including heterozygous familial and non-familial hypercholesterolemia) and diversified bond dyslipidemia in adult patients. As the first product of Innovent Bio in the field of cardiovascular and metabolic (CVM) diseases, Ibetic offers flexible treatment options with three administration intervals of 2/4/6 weeks, significantly reducing low-density lipoprotein cholesterol (LDL-C) levels while also ensuring a marked decrease in lipoprotein a [Lp (a)], with nearly 70% reduction in LDL-C and nearly 50% reduction in Lp(a). Ibetic successfully became China’s first domestically developed PCSK9 inhibitor included in the National Medical Insurance, bringing high-quality treatment options for clinical management of blood lipids in China, and enhancing the overall quality of life for many patients with hypercholesterolemia.
At the same time, the existing indications for Nailaike have successfully been renewed, with new indications added through a simplified renewal process successfully included in the National Medical Insurance Directory. Currently, the insurance payment scope includes: adult patients in chronic phase (CP) or accelerated phase (AP) of chronic myeloid leukemia (CML) with T315I mutation; adult CML-CP patients resistant to and/or intolerant to first and second-generation tyrosine kinase inhibitors (TKI). Nailaike is the first third-generation BCR-ABL inhibitor approved for marketing by China's National Medical Products Administration (NMPA). The commercialization of Nailaike in China is jointly managed by Innovent Bio and Ascletis Pharma.
Dr. Yu Dechao, founder, director, and CEO of Innovent Bio, stated: "We are very pleased that Ibetic has successfully been included in the national medical insurance drug catalog, which will greatly improve patients' access and affordability of medication, marking an important milestone for Innovent Bio and the many patients with hypercholesterolemia. At the same time, the new indication for Nailaike being included in the National Medical Insurance Directory will benefit a wider range of CML patients. Innovent Bio's strategic commitment and firm investment in tumor, cardiovascular and metabolic (CVM), autoimmune, and ophthalmological diseases, which are heavy societal burdens, upholds the corporate mission of 'Developing high-quality biological drugs that ordinary people can afford', with continuous innovation and perseverance. We will continue to focus on patient-centered approaches and actively cooperate with medical insurance policies across various regions to ensure that high-quality drugs benefit more patients and families as soon as possible."
About Sinibulo (Tolecamab Injection)
Sinibulo (Tolecamab Injection) is an innovative biological drug independently developed by innovent bio, an IgG2 fully human monoclonal antibody, which can specifically bind to the PCSK9 (proprotein convertase subtilisin/kexin type 9) molecule, increasing LDLR levels by reducing the endocytosis of low-density lipoprotein receptors (LDLR) mediated by PCSK9, thereby increasing LDL-C clearance and reducing LDL-C levels.
Sinibulo (Tolecamab Injection) has been approved in china and included in the national medical insurance catalog for the treatment of primary hypercholesterolemia (including heterozygous familial and non-familial hypercholesterolemia) and diversified bond dyslipidemia in adult patients.
About Nallik (Orebacitinib)
Nailik is an oral third-generation tyrosine kinase inhibitor (TKI) and is the first third-generation BCR-ABL inhibitor approved for marketing in china, showing outstanding effects on BCR-ABL and various BCR-ABL variants, including the T315I mutation.
Currently, Nailik has two approved indications in china included in the national medical insurance catalog, used for treating adult patients with chronic myeloid leukaemia chronic phase (CML-CP) or accelerated phase (-AP) with the T315I mutation; and for treating adult patients with CML-CP who are resistant to and/or intolerant of first and second-generation TKIs.
In July 2021, Innovent Bio reached a strategic cooperation with Ascentage Pharma (6855.HK) for the joint development and commercialization of Nailik in the chinese market.
*Note: Nailik is a registered trademark of Ascentage Pharma.
"Starting with trust and ending with action", developing high-quality biopharmaceuticals that the general public can afford is the ideal and goal of Innovent Biologics. Innovent Biologics was established in 2011 and is committed to the development, production, and sales of innovative drugs to treat major diseases such as tumors, metabolic diseases, and autoimmune diseases. On October 31, 2018, Innovent Biologics went public on the Main Board of the Hong Kong Stock Exchange with stock code: 01801. Since its establishment, the company has stood out among many biopharmaceutical companies with its innovative achievements and international operating model. It has established a product chain including 23 new drug varieties, covering multiple disease areas such as tumors, metabolic diseases, and autoimmune diseases, of which 6 varieties have been selected for the national "Major New Drug Creation" special project, and 3 products (Sintilimab Injection, brand name: Tyvyt, English trademark: TYVYT; Bevacizumab Injection, brand name: Duligotong, English trademark: BYVASDA; Camrelizumab Injection, brand name: Sulinno, English trademark: SULINNO) have been approved.
"Starting from trust and ending in action", developing high-quality biopharmaceuticals that ordinary people can afford is the mission and goal of LBX Pharmacy Chain Joint Stock. Established in 2011, LBX Pharmacy Chain Joint Stock is committed to researching, producing, and selling innovative drugs in the fields of oncology, autoimmunity, metabolism, ophthalmology, and other major diseases, benefiting more lives through our work. The company has already had 11 products approved for listing, namely Xindi Librow Injection (Dabosu), Bevacizumab Injection (Duyoutong), Adalimumab Injection (Sulixin), Rituximab Injection (Dabohua), Pemetrexed Tablets (Dabotan), Osimertinib Tablets (Nailike), Ramucirumab Injection (Xiziranzhe), Sunitinib Capsules (Ruituo), Efgartigimod Injection (Fukesu), Toripalimab Injection (Xinbile), and Fruquenecin tablets (Dabote). Currently, there are also 5 varieties under review by the National Medical Products Administration (NMPA), 3 new drug molecules entering Phase III or pivotal clinical studies, and another 17 new drug varieties in clinical research.
The company has reached more than 30 strategic cooperation agreements with international partners such as Eli Lilly, Roche, Sanofi, Adimab, Incyte and MD Anderson Cancer Center. While seeking self-development through independent research and development of innovative drugs, Innovent adheres to the development concept of economic construction centering on the people. Over the years, it has always had a scientific and kind heart, stuck to the principle of "patient-centered," concerned about the patients and their families, and actively fulfilled its social responsibilities. The company has launched and participated in a number of drug public welfare assistance projects, enabling more and more patients to benefit from the progress of life sciences and buy and afford high-quality biological drugs. Up to now, Innovent's patient assistance project has benefited more than 170,000 ordinary patients, and the total value of drug donations is 3.4 billion yuan. Innovent hopes to work together with everyone to improve the development level of China's biopharmaceutical industry, to meet the accessibility of the people's medication and the pursuit of a better life and health.
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