Key Innovative Drugs Expected to Gain Approval in China in 2025: A Pipeline Overview from Recent IPO Filings

According to the Economic Daily, in 2024, the National Medical Products Administration approved 48 innovative drugs and 65 innovative medical devices for marketing.The number of new drugs under research has jumped to the second place globally, and several domestically produced innovative drugs have been launched worldwide.In the upcoming 2025, a number of significant drugs are expected to be approved in China. Based on previous reports, Sina Medicine has compiled a list of 10 innovative drugs that are likely to be approved for marketing in China in 2025.

Drug Name: Amivantamab

Indications: Non-Small Cell Lung Cancer

R&D Company: Johnson & Johnson

Amivantamab, a first-in-class c-Met/EGFR bispecific antibody developed by Johnson & Johnson and Genmab, was first granted accelerated FDA approval in May 2021 for the treatment of adult patients with non-small cell lung cancer (NSCLC) harboring EGFR Exon 20 mutations whose disease has progressed during or after platinum-based chemotherapy. In March 2024, the FDA approved its use in combination with chemotherapy as a first-line treatment for NSCLC patients with EGFR Exon 20 mutations. This marks the first FDA-approved first-line therapy for such patients and has received a Category 1 recommendation from the NCCN guidelines.

Progress in China,Johnson & Johnson submitted the marketing application for Amivantamab for the first time in October 2023.; In January 2024, the marketing applications for Lanzetinib and Amivantamab were submitted to the CDE simultaneously.It is speculated that the declared indication is for the combination treatment of EGFR-mutated locally advanced or metastatic NSCLC patients.Results from the Phase III clinical MARIPOSA study showed that, for patients with EGFR mutations, the combination of Amivantamab and Lazertinib reduced the risk of disease progression or death by 30% compared to Osimertinib, and extended the median progression-free survival (mPFS) by 7 months. Additionally, Johnson & Johnson submitted a marketing application for the subcutaneous injection formulation of Amivantamab to the CDE in September 2024. It is currently under review, with an anticipated approval in China by Q1 2025.

Talquetamab (Talquetamab, Talvey)

Estimated Approval Time: 2025Q2

R&D Company: Johnson & Johnson

Talquetamab is a CD3/GPRC5D bispecific antibody and also the first drug targeting GPRC5D to gain approval. GPRC5D belongs to the G protein-coupled receptor family and is highly expressed in multiple myeloma, with its expression in normal tissues limited to the skin (hair follicles and eccrine sweat glands) and testes (seminiferous tubules). Additionally, its expression level is relatively independent of the BCMA target.

In August 2023, the FDA granted accelerated approval to talquetamab for the treatment of adult patients with relapsed or refractory multiple myeloma based on the results of the Phase II MonumenTAL-1 study. These patients had previously received at least four prior lines of therapy, including proteasome inhibitors, immunomodulatory agents, and anti-CD38 monoclonal antibodies. The results showed that when administered subcutaneously every two weeks at a dose of 0.8 mg/kg, the ORR reached 73.6%.

At the 2024 European Hematology Association (EHA) meeting, the efficacy data of Talquetamab in the Chinese population was disclosed for the first time. The results showed that the ORR for the 0.4 mg/kg QW and 0.8 mg/kg Q2W cohorts were 69.0% and 66.7%, respectively, with VGPR rates both exceeding 58%. The median time to first response was 1.3 months. In terms of safety, AEs related to taste, skin, and nails were mainly grade 1/2, and the incidence of taste-related adverse events (25.0–41.1%) was lower than the global rate (71.0–72.0%).

In February 2024, Talquetamab was submitted for marketing approval in China for the first time and included in the priority review., used as a single agent for the treatment of patients who have previously received at least three types of therapy (including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody)Relapsed or Refractory Multiple Myeloma(R/R MM) adult patients, expected to be launched in China in Q2 2025.

Drug Name: Risankizumab

Indications: Crohn's disease, etc.

R&D Company: Boehringer Ingelheim

In 2019, Risankizumab entered the global market for the first time and has been approved for multiple indications including plaque psoriasis, psoriatic arthritis, and Crohn's disease. In July 2023, Risankizumab was filed for marketing authorization in China for the first time, with the speculated indication being Crohn's disease.In June 2024, the new indication application for Risankizumab submitted by Johnson & Johnson was accepted, and the speculated indication is ulcerative colitis.

Risankizumab has conducted multiple head-to-head registrational clinical trials for plaque psoriasis and Crohn's disease. In July 2024, the NEJM published clinical results of risankizumab versus ustekinumab in treating Crohn’s disease. For patients who had previously received biologic therapy, the clinical remission rates were 58.6% versus 39.5%, and the endoscopic remission rates were 31.8% versus 16.2%. Risankizumab demonstrated superiority in both outcomes.

Notably, unlike the anti-IL-23 monoclonal antibodies already approved in China, risankizumab's indications being developed in China are all for inflammatory bowel diseases, including Crohn’s disease and ulcerative colitis.

Drug Name: Masptide

Indications: Weight control, Type 2 diabetes

R&D Companies: Innovent Biologics, Eli Lilly

Mashiduo peptide is a glucagon-like peptide-1 receptor (GLP-1R)/glucagon receptor (GCGR) dual agonist developed by Innovent Biologics and Eli Lilly. In addition to promoting insulin secretion, lowering blood sugar, and reducing weight by activating GLP-1R, Mashiduo peptide can also enhance weight loss efficacy by increasing energy expenditure through GCGR activation, while improving liver fat metabolism.

The First Phase III Clinical GLORY-1 Study of Masidutide in Chinese Overweight or Obese Adult Subjects Achieves Primary Endpoint and All Key Secondary Endpoints. The percentage change in body weight from baseline after 32 weeks of treatment in the Masidutide 6mg group was significantly better than that in the placebo group (-13.38% vs -0.24%).

In July 2024, Innovent Biologics announced that the Phase III clinical trial (DREAMS-1) of Mazdutide conducted in Chinese patients with type 2 diabetes met the primary endpoint and all key secondary endpoints, demonstrating comprehensive benefits in glycemic control, weight reduction, and cardio-renal metabolic indicators.

Innovent BiologicsSubmit the marketing application for Masitide peptide for long-term weight control in adult obesity or overweight patients to NMPA in February 2024.And atSubmit the second indication Type 2 Diabetes for marketing application in August 2024Currently, the marketing applications for both indications are under review and are expected to be approved by 2025Q2.

Drug Name: Solrepinib

Indications: Primary Immune Thrombocytopenia

R&D Company: Hutchmed

Solepinib, an orally administered selective Syk inhibitor independently developed by HUTCHMED, is currently under investigation for indications including immune thrombocytopenia (ITP) and warm antibody autoimmune hemolytic anemia (WAIHA). In January 2022, solepinib received Breakthrough Therapy Designation for the treatment of primary immune thrombocytopenia. Currently, no Syk inhibitors have been approved for marketing in China, and HUTCHMED...The marketing application for Solpepidib was submitted in January 2024 for the treatment of primary immune thrombocytopenia, and it is expected to become the first Syk inhibitor launched in China.

Drug Name: Tenapanor

Indications: Hyperphosphatemia in chronic kidney disease patients on hemodialysis

R&D Company: Ardelyx

Tenapanor, originally developed by Ardelyx, is the only globally approved NHE3 small molecule inhibitor. In 2023, the FDA approved tenapanor as an add-on therapy to reduce serum phosphorus levels in adult patients with chronic kidney disease (CKD). Additionally, the FDA approved tenapanor for use in adult CKD patients who respond inadequately or are intolerant to phosphate binders. As early as 2017, Fosun Pharma acquired exclusive clinical development and commercialization rights for tenapanor in mainland China, Hong Kong, and Macao Special Administrative Regions from Ardelyx for $125 million.In July 2023, Fosun Pharma submitted a marketing application to the National Medical Products Administration (NMPA) for Tenapanor for the treatment of hyperphosphatemia in chronic kidney disease patients undergoing hemodialysis.

Drug Name: Romosozumab

Indications: Osteoporosis

R&D Companies: UCB, Amgen

Romosozumab is an anti-SOST monoclonal antibody co-developed by UCB and Amgen. It specifically inhibits sclerostin, promoting bone formation and reducing bone resorption, thereby lowering the risk of fractures.

Currently, only one drug targeting SOST, Romosozumab, has been approved for marketing. It was approved in Japan, the United States, and Europe in 2019 for the treatment of osteoporosis populations at high risk of fractures (including postmenopausal women). However, due to potential cardiovascular risks, the FDA issued a black box warning for Romosozumab. In 2023, global sales of Romosozumab reached $1.16 billion.

In China, UCB and Amgen have completed a Phase 3 clinical study to evaluate the efficacy, safety, and tolerability of romosozumab in postmenopausal women with osteoporosis in China. Among drugs with the same mechanism, romosozumab is the fastest progressing in China.The first marketing application for the treatment of osteoporosis was submitted to NMPA in July 2024. It is currently in the queue for review and is expected to be approved in Q4 2025.

Drug Name: Zenidatamab

Indications: Biliary Tract Cancer

R&D Company: Zymeworks

Zanidatamab, a HER2-targeted bispecific antibody developed by Zymeworks, can simultaneously bind to two non-overlapping epitopes of the HER2 receptor, inducing dual HER2 signal blockade. In 2018, Zymeworks entered into an agreement with BeiGene, granting BeiGene the development and commercialization rights in Asia (excluding Japan), Australia, and New Zealand.

On June 7, 2024, BeiGene's HER2 bispecific antibody Zenidatamab had its marketing application accepted for use inPatients with HER2-high unresectable locally advanced or metastatic biliary tract cancer who have previously received systemic therapy. This indication has been granted priority review and is expected to be approved in Q2 2025.

This application is based on the results of the pivotal Phase II clinical trial HERIZON-BTC-01, in which zanidatamab demonstrated rapid and durable responses with manageable safety in refractory HER2-positive BTC patients.

Drug Name: Enalase

Indications: Breast Cancer

R&D Company: Roche

Inavolisib is an orally administered, highly selective PI3Kα inhibitor developed by Roche, targeting PIK3CA-mutated, HR-positive breast cancer. PIK3CA mutations are very common in breast cancer, occurring in approximately 40% of HR-positive tumors. The standout advantage of this product lies in its high selectivity, with a selectivity for PI3Kα that is over 300 times greater than other subtypes (PI3K β/δ/γ) and more than 2000 times greater than other members of the PIK family. Currently, Inavolisib ranks first in its category in China and second globally, trailing only Novartis' Alpelisib.

In May this year, the FDA granted Inavolisib Breakthrough Therapy Designation for use in combination with Palbociclib and Fulvestrant as a first-line treatment for adult patients with PIK3CA-mutated HR+/HER2- locally advanced or metastatic breast cancer. Currently, Inavolisib is the fastest-progressing selective PI3Kα inhibitor in development in China.Submitted an application for market approval to the CDE in June this year and has been included in the priority review directory, with the hope of being approved in China by Q3 2025.

Teplizumab (Tzield)

Expected Approval Time: 2025Q4

R&D Company: Sanofi

Teplizumab is the world's first and only disease-modifying therapy available for autoimmune Type 1 Diabetes, offering new hope for the prevention and treatment of Type 1 Diabetes. Teplizumab is a monoclonal antibody targeting CD3 that does not bind to Fc receptors. By binding to CD3 on the surface of effector T cells, it inhibits their attack on pancreatic β cells. The Fc region of teplizumab has been modified with amino acids to reduce its binding to complement and Fc receptors, thereby decreasing related toxic reactions.

In 2007, Eli Lilly acquired the exclusive rights to teplizumab from MacroGenics for an upfront payment of $41 million. However, in 2010, after the Phase III trial failed to meet its primary endpoint, Eli Lilly decided to discontinue further development. In 2018, Provention Bio acquired teplizumab from MacroGenics. A year later, teplizumab achieved a milestone breakthrough and was granted Breakthrough Therapy Designation by the FDA. In 2020, Provention Bio initiated a rolling BLA for teplizumab and, in October of the same year, reached a collaboration with Sanofi to pave the way for the commercialization of teplizumab.

Teplizumab was approved in the United States in November 2022 for adults and children aged 8 years and older with Stage 2 Type 1 diabetes to delay the onset of Stage 3 Type 1 diabetes, becoming the world's first and only immunotherapy approved by the FDA for delaying the onset of Type 1 diabetes. In 2023, Sanofi acquired Provention Bio for $2.9 billion to obtain the teplizumab asset.

Provention Bio inIn August 2024, an application for the marketing approval of Tilizumab for Type 1 Diabetes (JXSS2400070) was submitted to the NMPA and has been included in the priority review and approval process. It is expected to become the first drug in China to delay the onset of Type 1 Diabetes., expected to be approved in Q4 2025.

Editor of this article: Zhang Jie

Reference:

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