The company was co-founded in 2008 by Yantai Rongchang Pharmaceutical Co., Ltd., headed by Mr. Wang Weidong, and American scientist Dr. Fang Jianmin. The company is committed to discovering, developing, producing and commercializing first-of-its-kind, best-in-class biopharmaceuticals, and creating a number of new biological drugs with significant clinical value for major diseases such as autoimmunity, oncology, and ophthalmology. The company is an innovative biopharmaceutical company with a global perspective. Since its establishment, it has been focusing on therapeutic antibody drugs such as antibody drug conjugates (ADCs), antibody fusion proteins, monoclonal antibodies, and double antibodies. Main products: tetacip, vidicetumab, RC28, RC88, RC98, RC108, RC118, RC148, RC198, etc.
相关临床试验
130
24 进行中
药物批准
4
批准总数
监管机构
1
监管机构数
成立时间
2008
进行中（未招募）
17
13.1%
已完成
31
23.9%
尚未招募
7
5.4%
招募中
42
32.3%
终止
4
3.1%
Unknown
28
21.5%
撤回
1
0.8%
- Disitamab vedotin, a HER2-targeting antibody–drug conjugate, significantly improved outcomes in patients with HER2-positive breast cancer that has spread to the liver in the phase 3 portion of the RC48-C006 trial. - Patients treated with disitamab vedotin achieved markedly higher response rates and significantly extended progression-free survival compared with standard chemotherapy, with early overall survival signals pointing in the same direction. - The trial was specifically designed to enroll patients with HER2-positive disease and liver metastases, a population with historically grim prognosis and high unmet need. - Safety findings tracked the established profile of MMAE-based ADCs, with manageable toxicities including neutropenia, peripheral neuropathy, and elevated liver enzymes.
- The FDA approved the first therapy for primary IgA nephropathy in December 2021, and since then multiple novel drugs have received accelerated approval, transforming the treatment landscape. - A 2016 Kidney Health Initiative partnership redefined surrogate endpoints, establishing proteinuria reduction at 9 months as an acceptable marker, which made clinical trials feasible and affordable. - Currently, five therapies are approved in the U.S., including sparsentan, atrasentan, budesonide, sibeprenlimab, and iptacopan, with additional agents like atacicept and povetacicept under FDA review. - Experts emphasize that despite the "embarrassment of riches" in therapies, early patient identification remains the biggest challenge, as many patients present too late for optimal intervention.
- AbbVie has entered into a licensing agreement worth up to $745 million with Chinese biopharmaceutical company Haisco to acquire rights to multiple pain-related compounds outside of China, Hong Kong and Macau. - The deal includes $30 million upfront and up to $715 million in milestone payments for compounds in preclinical or early clinical development stages, including HSK-55718, a NaV1.8-targeting injectable for abdominal post-operative pain. - This acquisition is part of AbbVie's broader pipeline restocking strategy as the company faces significant revenue losses from Humira's patent expiration, with sales projected to drop over 90% from peak 2022 levels of $21.2 billion by 2032. - The agreement reflects a growing industry trend of pharmaceutical companies turning to China for innovative drug assets, with large pharma licensing 28% of its innovator drugs from China in 2024.
- Vor Bio has dosed the first patient in UPSTREAM SjD, a global Phase 3 registrational trial evaluating telitacicept in approximately 250 adult patients with active primary Sjögren's disease. - Telitacicept is the only BAFF/APRIL inhibitor currently in Phase 3 development for Sjögren's disease, targeting a condition that currently lacks approved disease-modifying therapies. - Previous Phase 3 results from China demonstrated statistically significant improvements in both ESSDAI and ESSPRI scores, providing clinical support for dual BAFF/APRIL inhibition in this autoimmune disease. - The trial's primary endpoint is the change from baseline in ESSDAI score at Week 48, with key secondary endpoints evaluating systemic disease activity, glandular function, and patient-reported symptoms.
- China's National Medical Products Administration has approved RemeGen's Phase I/IIa clinical trial application for RC288, a bispecific antibody-drug conjugate targeting PSMA and B7H3 for advanced solid tumors. - The approval represents a strategic advancement in RemeGen's oncology pipeline and demonstrates innovation in next-generation ADC technologies for cancer treatment. - RC288 will be tested as monotherapy in patients with locally advanced unresectable or metastatic malignant solid tumors in the upcoming clinical trial. - RemeGen reported strong 2025 revenue growth of 35.8% year-over-year to approximately RMB2.31 billion, driven by commercial success of telitacicept and disitamab vedotin.
- RemeGen's antibody-drug conjugate disitamab vedotin (RC48) received NMPA approval in China for treating adult patients with unresectable or metastatic HER2-low breast cancer with liver metastases. - This marks the fourth approved indication for disitamab vedotin in China, expanding its therapeutic reach across gastric cancer, urothelial carcinoma, HER2-positive breast cancer, and now HER2-low breast cancer. - The approval targets patients who have received at least one prior systemic therapy in the metastatic setting or who relapsed during or within 12 months after adjuvant chemotherapy. - RemeGen's stock price surged 30% following the announcement, reflecting investor confidence in the expanded commercial potential of China's first domestically developed ADC.
- AbbVie and RemeGen announced an exclusive licensing agreement for RC148, a novel PD-1/VEGF bispecific antibody being evaluated across multiple advanced solid tumors including lung cancers. - The deal includes a $650 million upfront payment and up to $4.95 billion in milestone payments, representing one of the largest bispecific antibody licensing agreements in recent years. - RC148 has demonstrated initial favorable antitumor activity in early clinical studies when combined with antibody-drug conjugates, potentially offering new treatment options for patients with high unmet medical needs. - The bispecific antibody aims to overcome tumor resistance mechanisms by simultaneously blocking PD-1 and VEGF pathways while creating favorable conditions for ADC activity.
- Pfizer has discontinued development of PF-08052666, an anti-mesothelin antibody-drug conjugate, citing "business strategic reasons" rather than safety concerns. - The decision follows a pattern of mesothelin-targeting therapy failures, including Zymeworks' T-cell engager ZW171, highlighting ongoing challenges with this target. - PF-08052666's discontinuation leaves RemeGen's RC88 as the only clinical-stage mesothelin-targeting ADC currently in development. - The asset, originally developed by MediLink and Harbour BioMed using Tmalin ADC technology, was licensed by Pfizer in December 2023 for $53 million upfront.
- The FDA approved nipocalimab (Imaavy) in May 2025 as the first therapy targeting the underlying cause of generalized myasthenia gravis in patients aged 12 and older with specific antibodies. - Over 20 companies are developing 22+ novel myasthenia gravis therapies, including promising candidates like Descartes-08, Telitacicept, and batoclimab showing sustained efficacy in Phase 2b and Phase 3 trials. - Recent clinical developments include Cartesian Therapeutics reporting 12-month sustained improvement with Descartes-08 and RemeGen sharing positive Phase 3 results for Telitacicept at the 2025 AAN Annual Meeting.
- RemeGen has entered into an exclusive licensing agreement with Santen Pharmaceutical for RC28-E, a VEGF/FGF dual-target fusion protein drug for ocular neovascular diseases, with potential payments totaling up to RMB 1.295 billion ($180 million USD). - RC28-E demonstrated significant improvements in visual acuity and reduced central subfield thickness in Phase II trials for diabetic macular edema, with Phase III trials currently underway for both DME and wet age-related macular degeneration. - The agreement grants Santen exclusive rights to develop and commercialize RC28-E in Greater China and eight Asian countries, while RemeGen retains global rights outside these territories. - RemeGen plans to submit a Biologics License Application for the DME indication in China in the second half of 2025, followed by a wAMD application in mid-2026.
