Huaxi Securities has released a research report maintaining an "Overweight" rating on REMEGEN (09995). The brokerage firm highlights the company's robust independent R&D capabilities, steady growth in core product sales, experienced management team, stable progress in its clinical indication pipeline, and rational domestic and international layout, expressing optimism about its post-launch commercial operational capabilities. The main points from Huaxi Securities are as follows.
Recent developments, according to the company's official WeChat account, indicate that on January 12, the company announced an exclusive licensing agreement with a holding company of the AbbVie group for its self-developed novel targeted PD-1/VEGF bispecific antibody drug, RC148. Under the agreement, AbbVie will obtain exclusive rights to develop, manufacture, and commercialize RC148 outside the Greater China region. The company will receive an upfront payment of $650 million and is eligible for up to $4.95 billion in development, regulatory, and commercial milestone payments, plus tiered double-digit royalties on net sales outside Greater China.
This deal marks another significant step in the company's global expansion strategy for its products, with international multinational corporation (MNC) collaboration aiding its overseas clinical layout. Following the successive out-licensing of its core products, Telitacicept (RC18) and RC28 in 2025, this latest transaction further validates the company's rapid pace of globalization. Data from PharmCube shows that, as of January 2026, a total of 17 PD-(L)1/VEGF bispecific antibody drugs worldwide have entered the clinical trial stage. Among these, five have signed business development (BD) agreements, including those from Akeso Biopharma, Prime Medicine, ImmuneOnco Biopharmaceuticals (terminated), Linnaeus Therapeutics, and 3SBio Inc., fully demonstrating the company's strong independent R&D capabilities.
Simultaneously, according to the collaborator's official website, the international MNC AbbVie possesses several differentiated products, such as Elahere (the world's first FRα-targeting ADC drug), the c-Met targeting ADC ABBV-400, the SEZ6 targeting ADC ABBV-706, and the CD19 targeting ADC ABBV-319, achieving coverage in both solid tumors and hematologic malignancies. RC148 is expected to form a strategic complement to AbbVie's existing oncology pipeline, further broadening the global reach of RC148.
Data for the PD-1/VEGF bispecific antibody is promising, with combination therapies beginning to show advantages. Based on data first disclosed by the company at the 2025 ESMO-IO congress: monotherapy achieved an Objective Response Rate (ORR) of 61.9% and a Disease Control Rate (DCR) of 100% in the efficacy-evaluable population. Combination therapy yielded an ORR of 66.7% and a DCR of 95.2%. Efficacy benefits were observed across all subgroups, with a manageable safety profile, preliminarily demonstrating clinical advantages. Furthermore, according to the company's website, RC148 has shown preliminary promising antitumor activity when used in combination with Antibody-Drug Conjugates (ADCs) in early clinical studies. The company is actively advancing related clinical trials, and the subsequent clinical potential is viewed favorably.
Risk factors include clinical progress falling short of expectations; commercial performance not meeting forecasts; and potential challenges from biosimilars for related products, volume-based procurement pressure, and changes in the competitive landscape.
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