NewTimeSpace | Breakthrough Designation for New Targeted Drug; GenFleet Therapeutics (02595.HK) Faces Commercialization Pressure Amid Heavy Book Losses

Innovation-driven pharmaceutical company GenFleet Therapeutics (02595.HK), holder of China’s first KRAS G12C inhibitor and hailed as the "first stock of domestic RAS-targeted therapies," has announced a significant new breakthrough.

On April 9, 2026, GenFleet Therapeutics announced that its KRAS G12D (ON/OFF) inhibitor, GFH375, was included in the Breakthrough Therapy Designation (BTD) list. The company's stock price responded immediately, closing at HK$38.80 on April 9, 2026, with a contrarian rise of 9.05%. Since March 2026, GenFleet Therapeutics has seen a cumulative gain of over 40%.

GFH375 Inhibitor Included in BTD List; Single-Day Stock Price Surges Over 9%

On April 9, 2026, GenFleet Therapeutics announced that its self-developed, highly selective oral KRAS G12D (ON/OFF) inhibitor, GFH375, has been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The designation is intended for the monotherapy of patients with KRAS G12D-mutant metastatic pancreatic cancer who have received at least one prior systemic treatment.

This marks the first monotherapy regimen of a KRAS G12D inhibitor to receive BTD for a pancreatic cancer indication in China. It is also the second BTD for this product, following its previous designation for non-small cell lung cancer (NSCLC).

Currently, GFH375 has pioneered the world’s first Phase III registrational study for a KRAS G12D inhibitor monotherapy (Kirin-Wing 01). This also represents the first registrational clinical study for an oral KRAS G12D inhibitor globally, being conducted simultaneously across nearly 40 research centers in China.

Since receiving approval for Phase I/II clinical trials in June 2024, data regarding the product’s performance in solid tumors, pancreatic ductal adenocarcinoma (PDAC), and NSCLC have been selected for breakthrough research abstracts and oral presentations at top-tier global oncology conferences, including ASCO, WCLC, and ESMO in 2025.

Regarding international markets, GFH375 (overseas code: VS-7375) is being advanced in clinical development by GenFleet’s partner, Verastem Oncology. It has been granted Fast Track Designation (FTD) by the U.S. FDA for the treatment of first-line and subsequent-line KRAS G12D-mutant pancreatic ductal adenocarcinoma.

In early March, GenFleet Therapeutics also announced that GFH375 received BTD from the CDE for patients with KRAS G12D-mutant NSCLC who have received at least one prior systemic treatment.

NewTimeSpace observed that, buoyed by a series of breakthrough announcements, the company’s stock price has rebounded strongly. As of the close on April 9, 2026, the share price was HK$38.80, a daily gain of 9.05% and a cumulative increase of 41.61% since the start of March 2026.

8 Drug Candidates, with 5 in Clinical Development

Public records indicate that GenFleet Therapeutics was founded in 2017. It is a commercial-stage biopharmaceutical company focusing on innovative and effective therapies in oncology, autoimmune, and inflammatory diseases. Prior to its IPO, the company had established a pipeline consisting of eight drug candidates, five of which are currently in clinical development stages.

NewTimeSpace learned that one of GenFleet’s core products, GFH925 (fulzerasib), is an internally discovered innovative drug approved for commercialization in China. Primarily used for advanced NSCLC, it is China’s first—and the world’s third—approved selective Kirsten rat sarcoma (KRAS) G12C inhibitor.

Another core product, GFH312, is a self-developed highly potent small-molecule inhibitor targeting receptor-interacting serine/threonine-protein kinase 1 (RIPK1). It has received IND approval from the FDA to conduct Phase II clinical trials in the U.S. to evaluate its safety and efficacy in patients with peripheral artery disease accompanied by intermittent claudication.

Beyond core products, GenFleet is building a comprehensive and differentiated RAS product matrix, including GFH375, GFH276, and GFS784. These respectively comprise an oral KRAS G12D small-molecule inhibitor with high bioavailability, another oral KRAS G12D inhibitor, and a novel drug modality utilizing large and small molecule synergy.

Furthermore, GenFleet is enriching its pipeline with GFS202A (a bispecific antibody targeting GDF15 and IL-6), GFH009 (a selective small-molecule compound targeting CDK9), and GFH018 (a potent small-molecule TGF-βR1 inhibitor).

Persistent Losses: 2025 Net Loss Approaches RMB 1.8 Billion

NewTimeSpace learned that GenFleet’s revenue is primarily derived from IP out-licensing, R&D services, and minor merchandise sales, rather than commercial revenue from self-owned products. This makes it the only Chapter 18A company at the IPO stage to possess both a Class 1 innovative drug on the market and out-licensing income.

In 2023 and 2024, the company recorded revenues of RMB 74 million and RMB 105 million, respectively, with net losses of RMB 508 million and RMB 678 million, representing considerable cumulative losses.

For the full year of 2025, revenue reached RMB 130 million (+24.4% YoY), but the net loss widened to RMB 1.795 billion, a 164.82% increase compared to 2024.

Revenue was mainly driven by overseas collaboration income related to GFH375. The massive widening of the net loss was primarily due to losses stemming from changes in the fair value of redemption liabilities on equity shares. On an adjusted basis, the net loss narrowed by 9.3% year-on-year to RMB 227 million.

Additionally, during the reporting period, GenFleet’s R&D costs decreased from RMB 332 million in 2024 to RMB 282 million. This was primarily due to a RMB 45.4 million reduction in termination fees for the GFH925 ex-China option and a RMB 28.77 million decrease in patent licensing fees for GFH925.

NewTimeSpace noted that GFH925 (trade name: Dabet®), GenFleet’s only marketed product, was conditionally approved by the NMPA in August 2024. However, according to the company's prospectus, merchandise sales for this product in the first four months of 2025 were only RMB 127,000, which is far from impressive.

The KRAS G12C inhibitor track is currently subject to fierce competition. Globally, over 20 candidates have entered clinical development. Companies with projects in Phase III or later stages include renowned firms such as InventisBio and Bristol Myers Squibb.

At present, GenFleet holds a cash reserve of RMB 2 billion, which is sufficient to support operations for the next 2–3 years, though the company remains in a state of continuous loss. The decline in R&D expenditure for 2025 may reflect a strategic contraction under financial pressure.

While the newly announced progress for GFH375 demonstrates potential for a global "best-in-class" profile, there remains significant uncertainty in the long journey from Phase III to NDA and eventual commercialization.

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