Haisco and Innovent Among Companies with Innovative Drugs Recommended for Priority Review in China

　　【Pharmaceutical Network Industry Dynamics] According to the public announcement on the website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration, several innovative drugs are proposed to be included in the priority review category, from companies such as Haisco and Innovent Bio.
 

Among them, Haisco's Cligelapib Benzene Sulfonate Capsules were proposed by the CDE to be included in the priority review on May 9, with the proposed indication being neuropathic pain.
 

Data show that Cligabalin Besylate Capsules are an oral γ-aminobutyric acid analog that binds to the α2δ subunit of voltage-sensitive calcium channels in the central nervous system, reducing calcium ion influx through voltage-dependent calcium channels in the central nervous system. This reduces the release of excitatory neurotransmitters such as glutamate, norepinephrine (NE), and substance P, demonstrating analgesic, antiepileptic, and anxiolytic activity.
 

Reportedly, this product is currently the only γ-aminobutyric acid analog in China approved for treating both diabetic peripheral neuropathic pain and postherpetic neuralgia. Compared with other drugs targeting the same site, pregabalin besylate demonstrates superior target binding and dissociation activity, with expected better analgesic efficacy. Additionally, it does not require titration during administration, and its overall safety profile is well-controlled. It is expected to become a treatment option for adult patients with diabetic peripheral neuropathic pain and postherpetic neuralgia, benefiting more patients.
 

Innovent Bio's IBI343 was proposed by the CDE for priority review on May 8. The proposed indication is for the treatment of locally advanced unresectable or metastatic CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma in patients who have received at least two prior systemic therapies.
 

Data show that IBI343 is an ADC drug targeting CLDN18.2. After binding to tumor cells expressing CLDN18.2, it can undergo CLDN18.2-dependent ADC internalization and release toxin drugs to cause DNA damage, leading to tumor cell apoptosis. The free toxin drug can also diffuse through the plasma membrane to reach and kill adjacent tumor cells, so IBI343 also has a bystander effect. IBI343 has demonstrated good anti-tumor activity in tumor-bearing pharmacological models with both low and high CLDN18.2 expression, while showing favorable safety profiles in preclinical models, with overall controllable safety.
 

It is reported that Innovent Bio is conducting a Phase III clinical trial of IBI343 as a late-line treatment for gastric cancer and pancreatic cancer. Previously, IBI343 had three indications granted Breakthrough Therapy designation. IBI343 also received Fast Track Designation (FTD) from the U.S. FDA, with the proposed indication being for advanced pancreatic ductal adenocarcinoma positive for CLDN18.2 expression in patients who have received at least one systemic therapy.
 

In addition, on May 7, two innovative drugs were proposed to be included in the priority review category, including Juventas' Naciaurel Cell Injection, with the proposed indication for pediatric relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL); and Merck's Nirogacestat Hydrobromide Tablets, with the proposed indication for adult patients with progressive desmoid tumors (also known as aggressive fibromatosis) requiring systemic therapy. On April 30, RY_SW01 Cell Injection from Jiangsu Ruiyuan Bio was also proposed to be included in the priority review, with the proposed indication for diffuse systemic sclerosis.
 

The priority review system is an important measure in China's drug review and approval reform, aiming to accelerate the market entry of innovative drugs with clinical value and address unmet clinical needs. Recently, multiple innovative drugs have been proposed for priority review, reflecting the growing support from regulatory authorities for innovative medicines. In the future, as these innovative drugs are expedited, they will further diversify clinical treatment options in China.
 

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