Zhangjiang Pharma Valley Innovations Accelerate: Clinical Submissions and Faster Approvals Emerge

Apr 20, 2026 16:40 CST Updated 16:40

Mabwell

Innovative Biopharmaceutical Company

Johnson & Johnson

Medical Device R&D and Manufacturer

GSK China

Pharmaceutical Manufacturer

At present, the companies in Zhangjiang Pharm Valley are continuously increasing R&D investment, advancing clinical trials, and accelerating the launch of innovative drugs, allowing more patients to benefit and helping Pudong become an international highland for the biopharmaceuticals industry.

Global First! Mabwell's Second Bispecific Antibody Innovative Drug Submits for Clinical Trial

Recently, the CDE official website showed,Mabwell in Zhangjiang Pharm ValleyThe clinical trial application for the novel Class 1 drug 6MW5311, submitted by Mabwell, has been accepted by the CDE, with the proposed indication being hematological tumors (acute myeloid leukemia, chronic myelomonocytic leukemia, and multiple myeloma).

(Source: CDE official website)

6MW5311 is the world's first innovative bispecific antibody drug targeting LILRB4/CD3 TCE to enter clinical trials, demonstrating broad prospects for clinical development and significant market potential. Its U.S. clinical trial application is currently in the pre-IND stage, with plans to formally submit an application to the FDA in the second quarter of 2026.

It is reported that Mabwell previously had one bispecific antibody new drug (6MW3211) enter the clinical stage, a CD47/PD-L1 bispecific antibody that can simultaneously block the PD-L1/PD-1 and CD47/SIRPα immune suppression signaling pathways, achieving a combined anti-tumor effect of T cells and macrophages.

Johnson & Johnson's First-in-Class Bispecific Antibody New Indication Submitted for Marketing Approval in China

On April 17, the CDE official website showed,Zhangjiang Pharm Valley Multinational Enterprise Johnson & JohnsonTelituximab has submitted a new indication marketing application in China and has been accepted. Based on the drug's research progress and domestic registration status, the indication for this submission is speculated to be for second-line treatment of adult patients with relapsed or refractory multiple myeloma.

(Image source: CDE official website)

In China, Talquetamab was approved for the first time in August 2024. As a monotherapy, it is indicated for adult patients with relapsed or refractory multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

On April 16, a new indication application for Teclistamab was included in the priority review list by the CDE. The indication is for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. In March this year, Johnson & Johnson also submitted a marketing application for this indication of Teclistamab to the European EMA.

Pudong's Multinational Companies Make New Progress in Innovative Drugs

Zhangjiang Pharma Valley Multinational Enterprise GSK ChinaIt was announced the other day that the NMPA had approved EaseCome.®(Demochizumab) is used in combination with intranasal corticosteroids to treat adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) whose disease is not adequately controlled by systemic corticosteroids and/or surgical treatment.

Notably, the NMPA recently approved Easly for maintenance treatment of severe eosinophilic asthma in adults and adolescents aged 12 years and above. Given the unmet need for ongoing treatment among patients with chronic rhinosinusitis with nasal polyps, industry experts believe that this approval of Easly is expected to redefine its treatment standard – only two injections per year can help alleviate symptoms caused by the disease.

Bayer's Small Molecule Lung Cancer Drug Approved for Marketing in China

Zhangjiang Pharm Valley Multinational Enterprise BayerAnnounced that the NMPA has approved Saveltinib tablets, a new targeted therapy for lung cancer, for monotherapy use in adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) who have HER2 (ERBB2) activating mutations and have previously received at least one systemic treatment. Saveltinib tablets are an orally administered small-molecule tyrosine kinase inhibitor (TKI). Previously, they were granted inclusion as a breakthrough therapy by the CDE of the NMPA, and their marketing application was given priority review.

Public data shows that NSCLC is the most common type of lung cancer, accounting for more than 85%. HER2 activating mutations are found in 2% to 4% of advanced NSCLC. Saveltinib can effectively inhibit mutant HER2, including HER2 exon 20 insertions and HER2 point mutations, and exhibits high selectivity for mutant epidermal growth factor receptor (EGFR) compared to wild-type.

Source: Pudong Release, Insight Database, Official Corporate WeChat