Innovent Announces Seven Innovative Products Including Mazdutide and PECONDLE® Successfully Included in the 2026 National Reimbursement Drug List

PALO ALTO, Calif. and SUZHOU, China, Nov. 14, 2026 /PRNewswire/ -- Innovent Biologics, Inc. (HKEX Stock Code: 01801), a biopharmaceutical company dedicated to the research, development, manufacturing, and commercialization of innovative drugs for major diseases including oncology, autoimmune, metabolic, and ophthalmic diseases, announced that seven innovative products of Innovent were successfully included in the updated National Reimbursement Drug List (2026) (the "NRDL").

Products included in the NRDL for the first time include mazdutide (a GCG/GLP-1 dual receptor agonist), PECONDLE® (picankibart injection, an IL-23p19 inhibitor), TABOSUN® (Ipilimumab N01 injection, a CTLA-4 inhibitor), and Vanflyta® (quizartinib, a Type II FLT3 inhibitor). Products with newly added indications included in the NRDL comprise TYVYT® (sintilimab injection, an anti-PD-1 monoclonal antibody) and Jaypirca® (pirtobrutinib, a non-covalent BTK inhibitor); and SINTBILO® (tafolecimab injection, a fully human PCSK9 monoclonal antibody) was successfully renewed. The updated NRDL will officially take effect from January 1, 2027.

Dr. Michael Yu, the Founder, Chairman of the Board and CEO of Innovent, stated: "We are highly pleased that the seven innovative drugs of Innovent have been successfully included in the National Reimbursement Drug List this time, covering disease areas with heavy societal burdens such as oncology (colon cancer, renal cancer, and hematological malignancies), cardiovascular and metabolic diseases, as well as autoimmune diseases. The inclusion of the innovative drugs in the NRDL will further enhance the accessibility and affordability for patients, allowing more of the public to benefit. With this, the lineup of Innovent's innovative drugs covered by the NRDL has expanded to 17, cumulatively benefiting over 20 million patients, and continuously fortifying the medication safeguards for patients through innovative achievements. Adhering to our corporate mission to 'empower patients worldwide with affordable, high-quality biopharmaceuticals', Innovent consistently places patient needs at its core, actively responds to the strategic call of 'Healthy China 2030', facilitates the construction of a universal health safeguard system through practical actions, and promotes the continuous improvement of people's health. We will actively cooperate with the implementation of medical insurance policies, ensuring that high-quality innovative medicines benefit countless households faster and more broadly.

Mazdutide
Innovent entered into an exclusive license agreement with Eli Lilly and Company for the development and commercialization of OXM3 (also known as mazdutide), a GLP-1R and GCGR dual agonist, in China. As a mammalian oxyntomodulin (OXM) analogue, mazdutide may offer additional benefits beyond those of GLP-1 receptor agonists—such as promoting insulin secretion, lowering blood glucose and reducing body weight. Mazdutide has demonstrated excellent weight loss and glucose-lowering effects in clinical studies. It has also shown benefits in reducing waist circumference, blood lipids, blood pressure, blood uric acid, liver enzymes, and liver fat content, as well as improving insulin sensitivity.

Mazdutide is newly included in the updated NRDL for: type 2 diabetes in adults. Mazdutide is the first and only approved GCG/GLP-1 dual receptor agonist globally. This inclusion into the NRDL will provide a better option for the comprehensive management of Chinese patients with type 2 diabetes.

PECONDLE® (picankibart injection)

Picankibart (IBI112) is a recombinant anti-interleukin-23p19 subunit (IL-23p19) antibody injection. It is a monoclonal antibody with independent intellectual property rights independently developed by Innovent, which specifically binds to the IL-23p19 subunit. By preventing IL-23 from binding to cell surface receptors, it blocks the IL-23 receptor-mediated signaling pathway to exert anti-inflammatory effects.

Picankibart injection is newly included in the updated NRDL for: adult patients with moderate to severe plaque psoriasis eligible for systemic therapy. Picankibart is the first and only domestic IL-23p19 inhibitor. It is also the first product among global IL-23p19 drugs with the same target to achieve a PASI 90 response rate exceeding 80% at 16 weeks in a Phase III registrational clinical trial, and possesses the longest maintenance dosing interval in its class (once every 12 weeks). This inclusion in the NRDL will effectively improve treatment convenience and patient compliance.

TABOSUN® (Ipilimumab N01 injection)

Ipilimumab N01 (IBI310) is a recombinant fully human anti-CTLA-4 monoclonal antibody independently developed by Innovent. Ipilimumab N01 can specifically bind to CTLA-4, thereby blocking CTLA-4-mediated T cell inhibition, promoting the activation and proliferation of T cells, enhancing the tumor immune response, and achieving anti-tumor effects.

Ipilimumab N01 injection is newly included in the updated NRDL for: use in combination with sintilimab for the neoadjuvant treatment of patients with resectable stage IIB-III microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colon cancer. As the world's only approved dual-immunotherapy combination regimen for this indication, it synergistically activates anti-tumor immunity through both the CTLA-4 and PD-1 pathways, providing patients with a short-course, chemotherapy-free, and 0-recurrence neoadjuvant treatment option, which fills the dual gaps in clinical practice and medical insurance coverage.

VANFLYTA® (quizartinib)

Quizartinib is an oral, highly potent type II FLT3 inhibitor that targets FLT3-ITD mutations, developed by Daiichi Sankyo and solely commercialized in Mainland China by Innovent.

Quizartinib is newly included in the updated NRDL for: newly diagnosed acute myeloid leukemia (AML) that is FMS-like tyrosine kinase 3 internal tandem duplication (FLT3-ITD) positive as detected by an adequate validated diagnostic test. It has effectively filled the gap in the NRDL coverage, addressed the shortcomings in clinical treatment, and practically alleviated the treatment burden of AML patients.

TYVYT® (sintilimab injection)

Sintilimab injection (IBI308) is an innovative PD-1 inhibitor drug jointly developed by Innovent and Eli Lilly and Company.

Sintilimab has been approved in China for ten indications, covering squamous non-small cell lung cancer, non-squamous non-small cell lung cancer (including EGFR/ALK wild type non-squamous NSCLC and EGFR-TKI treatment failed non-squamous NSCLC), hepatocellular carcinoma, gastric or gastroesophageal junction adenocarcinoma, esophageal squamous cell cancer, endometrial cancer, colon cancer, renal cell carcinoma and classical Hodgkin's lymphoma.

Two additional indications have been successfully included in the updated NRDL: sintilimab in combination with ipilimumab N01 as neoadjuvant treatment for patients with resectable stage IIB–III microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) colon cancer; and sintilimab in combination with fruquintinib for patients with locally advanced or metastatic renal cell carcinoma who have failed prior vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors (TKI) therapy and have not received programmed death receptor-1 (PD-1) or programmed death ligand 1 (PD-L1) inhibitor therapy in the first-line setting. The NRDL inclusion of two indications further broadens reimbursement coverage for the neoadjuvant treatment of patients with MSI-H/dMMR colon cancer and the combination treatment of targeted therapy and immunotherapy for second-line renal cell carcinoma patients.

Jaypirca® (pirtobrutinib)

Pirtobrutinib is a highly selective, non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor developed by Eli Lilly and Company, for which Innovent is responsible for the exclusive commercialization in Mainland China. In preclinical studies, pirtobrutinib is 300 times more selective for BTK versus 98% of other kinases tested^[i]. BTK is a validated molecular target found across numerous B-cell leukemias and lymphomas including mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL)^[ii],[iii].

Pirtobrutinib was approved in China in October 2024 and was officially included in the NRDL on January 1, 2026. One additional indication has now been successfully included in the updated NRDL: treatment of adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who have received at least one prior systemic therapy that included a Bruton's tyrosine kinase (BTK) inhibitor. This further broadens NRDL coverage for the treatment of this disease.

SINTBILO® (tafolecimab injection)

Tafolecimab injection (IBI306) is the first domestic fully human anti-PCSK9 monoclonal antibody independently developed by Innovent. By inhibiting proprotein convertase subtilisin/kexin type 9 (PCSK9) in blood plasma, it blocks its binding to the low-density lipoprotein receptor(LDLR), thereby preventing the endocytosis and degradation of LDLR, increasing the expression level and quantity of LDLR on the cell surface, enhancing the reuptake of low-density lipoprotein cholesterol (LDL-C) by LDLR, and decreasing the circulating LDL-C level, ultimately achieving the purpose of lowering blood lipids.

Tafolecimab was approved for marketing in August 2023 and was officially included in the NRDL on January 1, 2025. This successful contract renewal will further alleviate the financial burden on patients, enabling this advanced lipid-lowering therapy to benefit a broader patient population.

Looking towards the goals of the China's "15th Five-Year Plan", Innovent will remain committed to innovation-driven development, focus on the unmet clinical needs in the field of major diseases, and continuously advance the R&D, manufacturing and commercialization of high-quality innovative drugs, to serve people's lives and health with more innovative achievements, and contribute to the high-quality development of the biopharmaceutical industry and the building of a "Healthy China".

About Innovent

Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 20 products in the market. It has 1 asset under NMPA review, 6 assets in phase 3 or pivotal clinical trials, and 20 more molecules in early clinical stage.

Innovent has entered into more than 30 strategic partnerships with global players such as Eli Lilly, Roche, Takeda, Pfizer, Sanofi, Incyte, and MD Anderson Cancer Center, representing an aggregate value of over RMB 350 billion. These efforts have set a benchmark for the high quality outbound internationalization of China's innovative drug industry.

Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible.

For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.

Forward-Looking Statements

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions.

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