2026 JPM | RemeGen: Innovation Value Realized, Strengthening Future Global Competitive Edge

At 9:00 AM local time on January 15, at the 44th JPMorgan Healthcare Conference held in San Francisco, Rongchang Bio $REMEGEN (09995.HK)$$RemeGen Co., Ltd. (688331.SH)$CEO Dr. Jianmin Fang was invited to deliver a speech, systematically introducing the company's significant achievements over the past year in areas such as autoimmune diseases, oncology, and ophthalmology to investment institutions and industry representatives from around the globe. He also shared the outlook for 2026, highlighting advanced technology platforms with continuous innovation output capabilities, and clearly articulated the company’s future development strategy and global layout. This marks the 9th time Rongchang Bio has appeared on this international stage, which is regarded as a global benchmark for pharmaceutical innovation and capital trends.

【RC148】

Three Phase III Clinical Trials

Approved by Regulatory Authorities in China and the US

During the conference, Dr. Fang Jianmin disclosed the latest clinical trial progress of RC148.

Following active and effective communication with regulatory authorities in China and the US, three Phase III clinical trials of RC148 have been approved:

● Phase III clinical trial of RC148 combined with chemotherapy for first-line treatment of squamous non-small cell lung cancer approved by CDE

● Phase III clinical trial of RC148 combined with chemotherapy for second-line treatment of non-small cell lung cancer approved by CDE and granted Breakthrough Therapy Designation by CDE

● Phase III clinical trial of RC148 combined with chemotherapy for second-line treatment of non-small cell lung cancer indications approved by the US FDA

Also worth noting, at this year's JPM conferenceThe initial disclosure shows that RC148, in combination with platinum-based chemotherapy, demonstrated best-in-class potential in terms of objective response rate (ORR) as a first-line treatment for non-small cell lung cancer (NSCLC), with a favorable safety profile.

【泰它西普】

Proactive planning both domestically and internationally

Phase III clinical trials

Telitacicept has already received marketing approval for three indications: systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and generalized myasthenia gravis (gMG). The domestic marketing applications for the treatment of Sjögren's syndrome (SS) and IgA nephropathy (IgAN) have been formally accepted, marking a broader platform-oriented exploration to systematically address B-cell-mediated autoimmune diseases.

At the domestic level, Rongchang Biopharmaceutical will proactively lay out plans starting from 2026for six Phase III clinical trials in China covering indications such as connective tissue disease-associated interstitial lung disease (CTD-ILD), membranous nephropathy (MN), autoimmune encephalitis (AIE), ocular myasthenia gravis, pediatric SLE, and pediatric IgA nephropathy.

The significant unmet clinical needs and clear commercial logic behind this are evident: On one hand, there is a substantial unmet medical demand in these disease areas within China. For instance, the patient population with membranous nephropathy (MN) is as high as approximately 2.3 million, pediatric IgA nephropathy around 500,000, and conditions like connective tissue disease-associated interstitial lung disease (CTD-ILD) and autoimmune encephalitis (AIE) also each have hundreds of thousands of patients. On the other hand, the corresponding market potential is enormous. By 2040, the size of the Chinese market for membranous nephropathy is projected to reach about 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 potential market size across the six indications will surpass 11 billion yuan.

At the globalization level，The global Phase III clinical trial of Telitacicept for the treatment of gMG is expected to read out key data in the first half of 2027, and the global Phase III clinical trial for the treatment of SS is about to commence.

【维迪西妥单抗】

Frontline Impact

Deepening Combination Therapy

At this year’s JPMorgan conference, Disitamab Vedotin showcased a three-dimensional treatment plan that can be combined with other therapies, covering multiple cancer types and different treatment sequences.

● Urothelial Carcinoma (UC):The combination therapy with PD-1 as a first-line treatment for HER2-positive locally advanced or metastatic urothelial carcinoma is expected to receive domestic regulatory approval and launch by 2026.

● Gastric Cancer (GC):Two Phase III studies (RC48-C039, RC48-C040) targeting first-line HER2-low and HER2-positive gastric cancer, respectively, are currently progressing actively.

● Breast Cancer (BC):Following its approval for HER2-positive breast cancer with liver metastasis, the marketing application for single-agent use of Disitamab vedotin in HER2-low breast cancer has also been submitted.

【RC278】

Targeting CDCP1

Next-generation ADC 'Rising Star'

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 payload. Preclinical studies have shown that in colorectal cancer (CRC) PDX models, a single dose of RC278 can achieve deep and sustained tumor regression, with even complete remission (CR) observed, while demonstrating favorable safety characteristics. The drug has now entered Phase I/II clinical trials, with a focus on exploring its therapeutic potential in colorectal cancer, lung cancer, breast cancer, and other fields, with expectations to become the next blockbuster product.

【RC28】

Partnering with Santen China

Accelerating the path to market

RC28 is a VEGF/FGF dual-target fusion protein drug independently developed by Rongchang Bio for ocular neovascular diseases and has reached a key regional licensing collaboration with Santen China, a wholly-owned subsidiary of Santen Pharmaceutical.

The process of bringing RC28 to market in China is proceeding steadily:

● The marketing application for diabetic macular edema (DME) was accepted by the CDE at the end of September 2025and is expected to be approved for launch in the second half of 2026

● The marketing application for wet age-related macular degeneration (wAMD) is planned to be submitted in the second half of 2026

● Marketing application for diabetic retinopathy (DR) planned to be submitted in the second half of 2026

[Cutting-edge Technology Platform]

Building long-term competitiveness

At this year's JPMorgan conference, the company provided a systematic showcase of its four self-developed cutting-edge technology platforms for the first time.

● Target discovery platform:Using AI-driven multi-omics deep biological network analysis to systematically identify innovative targets

● Antibody Discovery Platform:Leveraging hybridoma and display technology platforms to rapidly screen monoclonal antibody and nanobody candidate molecules

● Protein Engineering Platform:Using AI-assisted design and structural biology techniques to develop customized preclinical candidate drugs (PCCs)

● ADC Technology Platform:Developing novel payloads, drug linkers, and site-specific conjugation methods to provide next-generation 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) at different stages of preclinical development, providing continuous momentum for the company’s future growth.

Among them, RC288 is a bispecific ADC targeting both PSMA and B7H3, primarily aimed at solid tumors like prostate cancer. This project constructs a bispecific structure using humanized monoclonal antibodies and VHH nanobodies, based on Top1 inhibitor payload, cleavable bivalent linkers, and site-specific conjugation with DAR=8. In preclinical studies, RC288 demonstrated favorable anti-tumor activity and safety profiles, with plans to initiate Phase I clinical trials in early 2026.

The comprehensive presentation at the JPMorgan conference fully demonstrates that Rongchang Bio’s innovative achievements are entering a value-intensive realization phase. Backed by continuously productive technical platforms, an increasingly mature commercialization system, and deep collaborations with international partners like AbbVie, Pfizer, Santen, and Vor Bio, its innovative value continues to be unlocked. Going forward, as key clinical data reads out, new indications expand, and leading pipelines progress systematically, Rongchang Bio will craft a globally competitive narrative in the innovative pharmaceutical landscape.

53K Views