Pfizer Inks $1.3B Deal for Global Rights to Kumquat's KRAS G12D Inhibitor Targeting High-Unmet-Need Tumors

　　【Pharmaceutical Network Industry DynamicsRecently, Pfizer, a multinational pharmaceutical company, reached an exclusive licensing agreement with Kumquat Biosciences, a U.S.-based clinical-stage biotechnology company, to acquire global rights to the latter's KRAS G12D inhibitor for up to $1.3 billion in total. According to the agreement, Kumquat will receive an upfront payment and milestone payments, while retaining the right to negotiate profit-sharing in the U.S. market.
 

Behind Pfizer's recent multi-billion-dollar "shopping spree" is the aim to target unmet needs in the global oncology field. KRAS gene mutations account for approximately 25% of all human tumors, with the G12D mutation being the most prevalent (37% in pancreatic cancer, 13% in colorectal cancer, and 4% in NSCLC). The mutated KRAS G12D locks into the GTP-bound state, continuously activating downstream MAPK/PI3K pathways and driving unlimited cell proliferation. The KRAS protein has a smooth surface and lacks a classical drug-binding pocket. In 2021, the approval of KRAS G12C inhibitors confirmed the feasibility of direct KRAS inhibition strategies, but due to differences in chemical structure, G12D poses higher drug design difficulties and presents pharmaceutical barriers.
 

Currently, there are no KRAS G12D-targeted drugs approved globally, with most competing pipelines in Phase I/II. Kumquat received FDA approval for the Investigational New Drug (IND) application of its KRAS G12D inhibitor in July 2025 and is about to initiate a Phase Ia dose-escalation study, with the first patient dosing expected to be completed by Q4 2025. Bayer will rapidly advance to a global multi-center Phase Ib/II trial after confirming the safety window.
 

EvaluatePharma predicts that the global market size for KRAS G12D-targeted drugs will reach $12 billion by 2035.
 

In addition to Pfizer, many multinational pharmaceutical companies have been "shopping" since 2025, with several of them showing confidence in the innovation capabilities of China's innovative drug enterprises. For example, at the end of July, Hengrui Pharma announced that it had reached a License-out cooperation agreement with GSK, with a total potential value of up to $12.5 billion, covering an innovative respiratory drug in clinical stage and up to 11 pre-clinical candidate projects. According to the announcement, Hengrui Pharma will grant GSK the exclusive global rights (excluding mainland China, Hong Kong SAR, Macao SAR, and Taiwan region of China) for the HRS-9821 project and the exclusive option for global licenses of up to 11 projects (excluding mainland China, Hong Kong SAR, Macao SAR, and Taiwan region of China). It is reported that HRS-9821 is an innovative drug under development for chronic obstructive pulmonary disease (COPD), with a dual mechanism of inhibiting both PDE3 and PDE4. It has demonstrated potential for bronchodilation and anti-inflammatory effects in preclinical and early clinical studies and has already received clinical trial approval from China’s National Medical Products Administration (NMPA). The project is planned to be developed into a dry powder inhalation formulation.
 

In May, the announcement disclosed by 3SBio showed that the company, along with its related parties 3SBio Inc. and Shenyang 3SBio Pharmaceutical Co., Ltd., jointly granted Pfizer the exclusive rights for global development, production, and commercialization (excluding mainland China) of the PD-1/VEGF bispecific antibody SSGJ-707. Pfizer retains the right to obtain commercial licensing for the product in mainland China by making additional payments. This transaction is still subject to antitrust regulatory approvals applicable in the United States and other overseas jurisdictions. According to the agreement, Pfizer will pay a non-refundable and non-deductible upfront payment of $1.25 billion, milestone payments for development, regulatory approval, and sales up to $4.8 billion, as well as tiered sales royalties in the double-digit percentage based on product sales in the licensed regions.
 

CSC Financial's 2025 Mid-term Strategy for Innovative Drugs states: In recent years, many of China’s innovative drug assets have gradually entered the global spotlight. With the significant increase in both the value and volume of BD transactions by Chinese innovative pharmaceutical companies, as well as frequent collaborations with renowned international pharmaceutical firms, the global influence of BD licensing continues to expand.
 

However, the commercialization challenges behind BD are equally worth noting, and quite a few pharmaceutical companies have later faced "returns" from multinational pharmaceutical companies. For China's innovative pharmaceutical companies, it is necessary to transform the phased victories brought by BD into the construction of an ecosystem with global competitiveness and sustainable innovation capabilities to avoid BD deals being as fleeting as "a flash in the pan."
 

Disclaimer: Under no circumstances shall the information or opinions expressed in this article constitute investment advice to any person.