G1 Therapeutics Secures Key Chinese Approval for Cancer Drug

In a significant development for its oncology portfolio, G1 Therapeutics has achieved regulatory approval in China for its drug lerociclib. This milestone arrives as the company integrates into its new owner, Pharmacosmos, following a 2024 acquisition valued at $405 million. The approval fuels questions about the future potential of G1's assets under this revised corporate structure.

Chinese health regulators have cleared lerociclib for use in treating adult patients with HR-positive, HER2-negative advanced breast cancer. The oral CDK4/6 inhibitor is approved for use in combination with either aromatase inhibitors or fulvestrant, targeting individuals whose cancer is locally advanced or has metastasized.

Clinical evidence indicates the therapy effectively halts tumor cell division by blocking specific enzymes. A key differentiator for lerociclib in the competitive oncology market is its favorable safety profile. The drug demonstrates a reduced incidence of severe side effects—such as bone marrow suppression and diarrhea—compared to similar existing treatments. This tolerability advantage is expected to be central to its commercial positioning.

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New Ownership and a Refined Focus

This progress occurs against the backdrop of G1 Therapeutics' acquisition by the Danish firm Pharmacosmos. The deal, completed at $7.15 per share, resulted in G1's delisting from public markets. Pharmacosmos is now leveraging the acquisition to bolster the commercial rollout of another G1 asset, COSELA® (trilaciclib). This medication is designed to minimize chemotherapy-induced bone marrow damage in patients being treated for extensive-stage small cell lung cancer.

Following clinical trials that did not show the desired survival benefit for trilaciclib in other cancer types, management has streamlined its research efforts. Development for indications outside of the approved lung cancer use has been largely discontinued. The company is now executing a focused strategy on commercializing its existing pipeline.

The immediate commercial priorities involve the launch of lerociclib in China, which will be conducted by the company's partner, Genor Biopharma. Concurrently, Pharmacosmos is driving deeper market penetration for COSELA®. Further Phase 2 data evaluating trilaciclib in combination with antibody-drug conjugates (ADCs) is under review. These results will determine whether the drug's application might eventually be expanded.