通用名:泰它西普 商品名:泰爱® 研究代号:RC18


泰它西普是一种TACI-Fc融合蛋白,靶向与B细胞介导自身免疫性疾病有关的两个重要细胞信号分子B淋巴细胞刺激因子(BLyS)和增殖诱导配体(APRIL)。与其他用于治疗SLE针对靶向单靶点或者不同靶点的市售及管线生物疗法相比,泰它西普是潜在的同类首创的BLyS/APRIL双靶向SLE疗法。我们正对该候选药物开展广泛的临床开发计划,针对多种B细胞介导的、医疗需求未得到满足或未被充分满足的自身免疫性疾病。

基于我们最近在中国完成的IIb期注册性临床试验,泰它西普对SLE患者显示出令人鼓舞的疗效及安全性。中国药监局于2019年11月受理了我们将泰它西普用于治疗SLE的NDA,并于2019年12月授予我们优先审评资格。

在中国进行临床开发及监管流程的同时,我们计划将推行泰它西普的全球临床开发计划,以最大化其治疗及商业价值。于2020年4月15日,FDA授予泰它西普快速通道资格,这有可能加快FDA的审核及可能的批准流程。获得快速通道资格后,沟通的频密程度能确保快速解决问题及相关事宜,这常会促使药物提早获得批准并使病人早日获得药物。


Leveraging our strong research and development (R&D) platforms, we have discovered and developed a robust pipeline of more than ten drug candidates.

  • Disitamab Vedotin (RC48)

    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)

    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

    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.

Annotation

*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.

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