Portfolio News
On January 15 at 9:00 a.m. local time, Dr. Jianmin Fang, CEO of RemeGen, took the stage at the 44th J.P. Morgan Healthcare Conference in San Francisco—a premier global event for pharmaceutical innovation and investment trends. In his keynote address, Dr. Fang showcased the company’s groundbreaking progress over the past year in treating autoimmune disorders, cancer, and eye diseases, while also painting a vision for 2026. He emphasized RemeGen’s cutting-edge technology platforms, which consistently drive innovation, and detailed the company’s strategic roadmap for global expansion. This marked RemeGen’s ninth appearance at the conference, solidifying its role as a leader in the biopharmaceutical industry.
RC148
Three Phase III clinical trials
Approved by regulatory authorities in China and the United States
During the conference, Dr. Fang Jianmin shared updates on the ongoing clinical trials for RC148.
After active and effective communication with regulatory agencies in China and the United States, RC148 has obtained approval for three Phase III clinical trials, which are:
● The Phase III clinical trial of RC148 combined with chemotherapy as first-line treatment for squamous non-small cell lung cancer (NSCLC) has been approved by the CDE (Center for Drug Evaluation).
● The Phase III clinical trial of RC148 combined with chemotherapy as second-line treatment for non-small cell lung cancer (NSCLC) has been approved by the CDE, and RC148 has been granted Breakthrough Therapy Designation by the CDE.
● The Phase III clinical trial of RC148 combined with chemotherapy as second-line treatment for non-small cell lung cancer (NSCLC) has been approved by the U.S. FDA (Food and Drug Administration).
Also noteworthy is that at this JPM conference, it was disclosed for the first time that RC148 combined with platinum-based chemotherapy demonstrated best-in-class potential in objective response rate (ORR) for first-line treatment of non-small cell lung cancer (NSCLC), with favorable safety.
● The RC148 combination chemotherapy for second-line treatment of NSCLC has been approved by the U.S. FDA to initiate Phase III clinical trials.
Telitacicep
Ahead-of-the-curve planning for global Phase III clinical trials
Telitacicept, a promising biologic drug, has already hit the market with approvals for three autoimmune conditions: systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and generalized myasthenia gravis (gMG). Meanwhile, its applications to treat Sjögren's syndrome (SS) and IgA nephropathy (IgAN) have been formally submitted for review in China. The drug is now evolving beyond single-disease treatment into a broader platform approach aimed at systematically tackling B cell-mediated autoimmune disorders.
At the domestic level, from 2026, RemeGen will prospectively lay out Phase III clinical trials in China for six indications, including connective tissue disease-related interstitial lung disease (CTD-ILD), membranous nephropathy (MN), autoimmune encephalitis (AIE), ocular myasthenia gravis, pediatric SLE, and pediatric IgA nephropathy.
The enormous clinical demand and commercialization logic behind it are clearly visible: On one hand, there is a huge unmet medical need in these disease areas domestically, with membranous nephropathy (MN) affecting approximately 2.3 million patients, pediatric IgA nephropathy around 500,000, and connective tissue disease-associated interstitial lung disease (CTD-ILD) and autoimmune encephalitis (AIE) each having a patient base of hundreds of thousands. On the other hand, the corresponding market potential is vast. By 2040, the market size for membranous nephropathy in China is projected to reach approximately 4.8 billion yuan, while autoimmune encephalitis and CTD-ILD are expected to exceed 3.1 billion yuan and 2.4 billion yuan, respectively. The combined potential market size for these six indications could surpass 11 billion yuan.
On a global scale, the key data from the global Phase III clinical trial of Telitacicept for the treatment of gMG is expected to be read out in the first half of 2027, and the global Phase III clinical trial for the treatment of SS is about to be initiated.
Disitamab vedotin
Impact the first-line
Deepen combination therapies
At this JPM conference, the antibody-drug conjugate vedicitumab demonstrated a comprehensive treatment strategy that can be combined, covers multiple cancer types, and applies to different lines of therapy.
● Urothelial carcinoma (UC): The combination therapy of PD-1 with first-line treatment for HER2-positive locally advanced or metastatic urothelial carcinoma is expected to be approved domestically in 2026.
● Gastric cancer (GC): Two Phase III studies (RC48-C039, RC48-C040) targeting first-line HER2-low and HER2-positive gastric cancer, respectively, are actively advancing.
● Breast cancer (BC): Following its approval for HER2-positive breast cancer with liver metastases, the marketing application for disitamab vedotin as a monotherapy for HER2-low breast cancer has also been submitted.
RC278
The next-generation ADC "nova" targeting CDCP1
RC278 is an ADC targeting the novel tumor antigen CDCP1, utilizing site-specific conjugation technology with a drug-to-antibody ratio (DAR) of 8, and carrying a potent topoisomerase I inhibitor as its payload. Preclinical studies demonstrated that in colorectal cancer (CRC) PDX models, a single dose of RC278 achieved deep and sustained tumor regression, with even complete responses (CR) observed, while exhibiting a favorable safety profile. The drug has now entered Phase I/II clinical trials, focusing on exploring its therapeutic potential in colorectal cancer, lung cancer, breast cancer, and other areas, positioning it as a potential blockbuster product.
RC28
Hand in hand with Santen China
Accelerating the market launch process
RC28 is a VEGF/FGF dual-target fusion protein drug independently developed by RemeGen for ocular neovascular diseases, and has reached a significant regional licensing agreement with Santen China, a wholly-owned subsidiary of Santen Pharmaceutical.
The market launch process of RC28 in China is steadily advancing:
● The market application for diabetic macular edema (DME) was accepted by the CDE in late September 2025 and is expected to be approved for launch in the second half of 2026.
● The market application for wet age-related macular degeneration (wAMD) is planned to be submitted in the second half of 2026.
● The market application for diabetic retinopathy (DR) is planned to be submitted in the second half of 2026.
Cutting-edge Technology Platform
Building Long-term Competitiveness
At this JPM conference, the company systematically showcased its four self-developed cutting-edge technology platforms for the first time.
● Target Discovery Platform: Utilizes AI-driven multi-omics deep biological network analysis to systematically identify innovative targets.
● Antibody Discovery Platform: Leverages hybridoma and display technology platforms to rapidly screen monoclonal antibody and nanobody candidate molecules.
● Protein Engineering Platform: Employs AI-assisted design and structural biology technologies to develop customized preclinical candidate drugs (PCCs).
● ADC Technology Platform: Develops novel payloads, drug linkers, and site-specific conjugation methods to deliver next-generation novel ADC drug candidates.
Based on these platforms, the company's early-stage R&D pipeline is vibrant and well-stocked, including multiple cutting-edge projects such as bispecific ADCs, trispecific T-cell engagers (TCEs), and myeloid cell engagers (MCEs), which are at various stages of preclinical development, providing a continuous stream of momentum for the company's sustained future growth.
Among them, RC288 is a bispecific ADC targeting both PSMA and B7H3, primarily aimed at solid tumors such as prostate cancer. The project employs a humanized monoclonal antibody and VHH nanobody to construct the bispecific structure, utilizing a Top1 inhibitor payload, cleavable bivalent linker, and site-specific conjugation with DAR=8. In preclinical studies, RC288 has demonstrated promising antitumor activity and safety profiles, with plans to initiate Phase I clinical trials in early 2026.
Through this comprehensive showcase at the JPM conference, it is evident that RemeGen's innovative achievements have entered a phase of intensive value realization. Leveraging sustainably productive technology platforms, an increasingly mature commercialization system, and deep collaborations with international partners such as AbbVie, Pfizer, Santen, and Vor Bio, the company continues to unlock its innovative potential. Moving forward, with the sequential readout of key clinical data, ongoing expansion into new indications, and the orderly advancement of cutting-edge pipelines, RemeGen is poised to craft a globally competitive new narrative in the landscape of innovative drugs.
