Telitacicept (RC18) is a kind of TACI-Fc fusion protein targeting two important cell-signaling molecules, B-cell lymphocyte stimulator (BLyS) and a proliferation inducing ligand (APRIL), implicated in B cell-mediated autoimmune diseases. Telitacicept is potentially the first-in-class BLyS/APRIL dual-targeted therapy for SLE, in comparison with other marketed and pipeline biologic therapies for SLE with single or different drug targets. We are carrying out a broad clinical development program for this drug candidate targeting a variety of B cell-mediated autoimmune diseases with unmet or underserved medical needs.
Telitacicept has received marketing approval from the NMPA on 9th March, 2021.
Disitamab vedotin (RC48) is a novel anti-HER2 antibody-drug conjugate (ADC) which is currently across various solid tumor types. RC48 is characterized by a higher affinity to HER2 compared to standard of care and superior anti-tumor activity. It was the first domestically-developed ADC in China approved by the CDE for clinical development in China.
RemeGen is implementing a differentiated development and commercial strategies for disitamab vedotin for prevalent HER2 expressing cancers lacking effective treatment methods. The indications of disitamab vedotin include HER2 expressing (IHC 1+ or above) cancer, such as gastric cancer (GC) and urothelial carcinoma (UC) (currently in registered clinical trials in China), and HER2 low-expressing cancer (IHC 2+ / FISH- or IHC 1+), such as HER2 low-expressing breast cancer (currently in registered clinical trial in China).
Telitacicept (RC18) is a potentially novel first-in-class TACI-Fc fusion protein for the treatment of B cell-mediated autoimmune diseases. It targets and neutralizes two cell-signaling ligands, BLyS and APRIL, to down modulate the overexpression of B-cells implicated in autoimmune diseases. We are carrying out a broad clinical development program spanning 7 indications for telitacicept targeting a variety of B cell-mediated autoimmune diseases with unmet or underserved medical needs. Systemic lupus erythematosus (SLE) is the lead indication of Telitacicept.
In addition to SLE, we are actively developing telitacicept for six other B cell-mediated autoimmune diseases in late-stage clinical trials in China, including two registrational clinical studies in neuromyelitis optica spectrum disorder (NMOSD) and rheumatoid arthritis (RA); two Phase II studies in IgA nephropathy (IgAN) and Sjögren’s syndrome (SS) (indications with high prevalence but lacking efficacious treatments); and two Phase II studies in hard-to-treat rare diseases, including multiple sclerosis (MS) and myasthenia gravis (MG).
RC28 is a potential first-in-class VEGF/FGF dual-targeting fusion protein for the treatment of eye diseases. Compared to single-target VEGF inhibitors, RC28 has the potential to more effectively inhibit the abnormal blood vessel growth implicated in various eye diseases through both VEGF and FGF pathways, potentially allowing for a better dosing profile. RC28 has completed a Phase I dose escalation study in patients with wet age-related macular degeneration (wet AMD) in China.
*Denotes the Company’s core drug candidates.
Abbreviations: 1H = first half; ADC = antibody drug conjugate; HiBody = a novel bifunctional antibody; mAb = monoclonal antibody; Q3 = third quarter.
1. The FDA has provided clearance for the Company to proceed with the Phase III clinical trial of telitacicept for SLE in the U.S in January 2020 and granted telitacicept Fast Track designation in April 2020.
2. HER2-expressing refers to a human epidermal growth factor receptor 2 (HER2) status of tumor cells identified with a test score of IHC 1+ or above. HER2 low-expressing refers to a HER2 status of tumor cells identified with a test score of IHC 1+ or IHC 2+/FISH-. HER2 non-expressing refers to HER2 status of tumor cells identified with a test score of IHC 0.
3. In China, the Company is (i) finalizing a Phase II registrational trial to evaluate disitamab vedotin as monotherapy for the treatment of HER2 over-expressing (IHC 2+ or IHC 3+) gastric cancer (GC), and (ii) conducting a Phase I clinical trial to evaluate distamab vedotin in combination with PD-1 inhibitor for the treatment of HER2 over-expressing GC.
4. In China, the Company is conducting (i) a Phase II registrational trial to evaluate disitamab vedotin as monotherapy for the treatment of HER2 over-expressing (IHC 2+ or IHC 3+) urothelial cancer (UC), and (ii) a Phase Ib/II trial to evaluate disitamab vedotin in combination with PD-1 inhibitor for the treatment of UC.
5. The FDA has provided clearance for the Company to proceed with the Phase II clinical trial of disitamab vedotin in the U.S in April 2020.
6. The Company has initiated pre-IND discussion with the FDA to obtain their consents for disitamab vedotin’s Phase II clinical trial in GC in the U.S.
7. The Company has completed a Phase I trial of RC28 in wet age-related macular degeneration (wet AMD) in August 2019 in China, of which the primary endpoint of safety was met. In July 2018, the Company obtained the NMPA’s approval to conduct Phase I, II and III trials of RC28 according to their clinical development plan and progress, and the NMPA has not raised any objections towards clinical trials of RC28 since then. The Company is currently conducting a Phase Ib trial of RC28 to further evaluate its efficacy and safety for the treatment of wet AMD.
8. The Company plans to initiate a Phase II trial for RC28 in diabetic macular edema in the second half of 2020 in China.
9. The Company plans to initiate a Phase II trial for RC28 in diabetic retinopathy in the second half of 2020 in China.
10. Registrational trial, or pivotal trial, means the clinical trial or study to demonstrate clinical efficacy and safety evidence required before submission for drug marketing approval.
RemeGen’s global GMP compliant manufacturing facility in Yantai, China covers an area of 30,000 m2 and features state-of-the art equipment. Our manufacturing facility currently houses six 2000L disposable bioreactors (total capacity of 12,000L) to enable large scale production of recombinant protein. Our current manufacturing facilities are capable of supporting commercialization in China with an annual output of up to 2.3 million vials of antibodies and 1.5 million vials of ADCs.
RemeGen has integrated production capacities to produce monoclonal antibodies, fusion proteins, antibody-drug conjugates, bifunctional antibodies and other complex molecules. Its factory buildings and the ancillary facilities have reached world leading. We have built a professional quality assurance team led by medical professionals with decades of biopharmaceutical development experience in Europe or the United States. We have been focused on building a quality management system that meets the international standards to expand our global outreach. RemeGen have established the quality policy of Making Medicines With Integrity, Scientific Management,Continuous Improvement and Pursuit of Excellence. We shall build a quality management system that meets the GMP requirements of FDA, EMA and NMPA.