Four Innovative Drugs from GenFleet, Johnson & Johnson, and Others Nominated for Breakthrough Therapy Designation

　　【Pharmaceutical Network Product InformationAccording to the disclosure on the website of the Center for Drug Evaluation of the National Medical Products Administration, four innovative drugs are proposed to be included in the breakthrough therapy category, including GFH375 tablets from GenFleet Therapeutics, Amivantamab injection (subcutaneous injection) from Johnson & Johnson, Quabodepistat tablets from China OTSUKA Pharmaceutical Co., Ltd., and HSK39004 inhalation powder from Haisco.
 

Among them, GenFleet Therapeutics' GFH375 tablet is proposed to be included in the breakthrough therapy for the indication of metastatic pancreatic cancer with KRAS G12D mutation that has received at least one systemic treatment. The public announcement period is from March 31, 2026, to April 8, 2026.
 

Pancreatic cancer refers to cancer that occurs in the pancreas, with a high degree of malignancy and poor prognosis. When cancer cells spread to other parts of the body, it is referred to as metastatic, with symptoms including abdominal pain, jaundice, and weight loss. It was reported that in November 2025, GenFleet Therapeutics initiated a multi-center, open-label, randomized controlled Phase III clinical study to evaluate the efficacy and safety/tolerability of GFH375 monotherapy versus investigator’s choice chemotherapy in patients with previously treated metastatic pancreatic cancer harboring the KRAS G12D mutation.
 

Data show that GFH375 is a high-activity, highly selective small molecule inhibitor. Preclinical studies have shown that its inhibitory effect on tumor growth increases with the dosage and duration of treatment. GenFleet Therapeutics has reached a cooperation agreement with Verastem for the development of GFH375, granting Verastem the rights to develop and commercialize it outside of Greater China. It is reported that the indication of GFH375 for non-small cell lung cancer (NSCLC) patients who have received at least one systemic treatment and have KRAS G12D mutations was included in the breakthrough therapy program in February this year.
 

Johnson & Johnson's Amivantamab Injection (Subcutaneous Injection) is proposed to be included in the breakthrough therapy designation for the treatment of adult patients with HPV-unrelated recurrent or metastatic squamous cell carcinoma of the head and neck (R/M HNSCC) who have progressed during or after platinum-based chemotherapy and PD-(L)1 inhibitor treatment. The public announcement period is from March 31, 2026, to April 8, 2026.
 

Data shows that Amivantamab (brand name Rybrevant), developed by Johnson & Johnson, is a bispecific monoclonal antibody. This next-generation targeted therapy can simultaneously attack cancer cells: it blocks the protein expression of the epidermal growth factor receptor (EGFR) to inhibit tumor growth while also blocking the MET signaling pathway to prevent cancer cells from evading treatment. Additionally, it activates the patient's immune system to attack cancer cells. Amivantamab is administered via subcutaneous injection, which is more convenient than traditional infusion therapy, requiring only a single injection for administration.
 

China OTSUKA Pharmaceutical Co., Ltd.'s Quabodepistat tablets have been proposed for inclusion in the breakthrough therapy designation for the treatment of multidrug-resistant tuberculosis, with the public announcement period from March 30 to April 7, 2026. Data shows that quabodepistat (also known as OPC-167832) is an oral DprE1 inhibitor that achieves bactericidal effects by inhibiting a key enzyme system involved in the synthesis of mycobacterial cell wall arabinogalactan, making it a new mechanism anti-tuberculosis compound. Overseas, the 2b/c phase study of quabodepistat in combination with delamanid and bedaquiline has reported positive interim results, suggesting the potential to shorten the treatment duration to approximately four months; its early clinical trials also demonstrated good early bactericidal activity and tolerability.
 

In addition, Haisco's HSK39004 inhalation powder is proposed to be included in the breakthrough therapy for the indication of chronic obstructive pulmonary disease (COPD), with the public announcement period from March 27 to April 3, 2026. Data shows that HSK39004 is a dual inhibitor of PDE3/4, which works through a dual mechanism to dilate bronchi and reduce the release of inflammatory factors, thereby improving airflow limitation and airway inflammation, used as an adjuvant maintenance treatment for chronic obstructive pulmonary disease (COPD). The drug currently has two dosage forms: inhalation suspension and inhalation powder, both of which are currently undergoing Phase II clinical trials in China.
 

Four innovative drugs are currently proposed to be included in the list of breakthrough treatments, covering the fields of oncology, tuberculosis, and chronic respiratory diseases. These drugs all target clinical treatment pain points and, with novel mechanisms or differentiated advantages, bring new hope to patients with severe conditions such as pancreatic cancer, head and neck tumors, multidrug-resistant tuberculosis, and COPD, reflecting the core direction of pharmaceutical innovation focusing on difficult-to-treat diseases and accelerating breakthroughs.
 

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