As announced by Rongchang Biotechnology on the evening of August 13th, the company has independently developed the BLyS/APRIL dual target fusion protein innovative drug, Taitacept (RC18, trade name: Taiai) ®) The Phase III clinical trial for the treatment of systemic myasthenia gravis (gMG) has reached the primary endpoint of the clinical trial design.

 

 

 

Clinical research results have shown that tacrolizumab can sustainably and effectively improve clinical symptoms in patients with systemic myasthenia gravis, demonstrating good efficacy and safety. The company will submit its marketing application to the Center for Drug Evaluation (CDE) of the National Medical Products Administration at an appropriate time.

 

 

 

Rongchang Biotechnology introduced that this is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study aimed at evaluating the efficacy and safety of tacept in the treatment of patients with systemic myasthenia gravis. Clinical research results have shown that tacrolizumab can sustainably and effectively improve the clinical condition of patients with systemic myasthenia gravis. It is reported that Rongchang Biotechnology also announced on August 5th that its global multi center Phase III clinical trial for myasthenia gravis indication has enrolled the first patient in the United States. At present, Taitacept has been recognized as a breakthrough treatment variety by the China National Medical Products Administration, an orphan drug by the US FDA, and a fast track drug in the field of myasthenia gravis.

 

 

 

The fully human targeted BCMA chimeric antigen receptor autologous T cell injection (Ikiolanse injection) independently developed by Reindeer Biology was approved by the National Medical Products Administration (NMPA) Evaluation Center (CDE) in early 2024 for clinical trials of refractory systemic myasthenia gravis, a newly added and expanded indication.

 

 

 

According to the industry, Ikiolanse Injection (trade name: Fukosol) ®) It has been approved by the National Medical Products Administration on June 30, 2023 for the treatment of relapsed and refractory multiple myeloma. The approval of the IND for myasthenia gravis further expands the indications of Ikiolanse injection.

 

 

 

Reindeer related personnel have stated that for a long time, the treatment of systemic myasthenia gravis patients has relied mainly on expert experience judgment and traditional treatment plans. Existing drug therapies are not effective for all patients, and 10% -15% of MG patients have refractory diseases in clinical practice. The treatment of these refractory MG patients and potential crisis patients is an important challenge facing clinical practice, and there is an urgent need for safe and effective innovative treatments to solve these problems. It stated that in the company's IIT research, it is pleased to see that Ikiolanse injection can prevent disease progression and show early signs of reversing the disease, which is expected to change the treatment pattern of MG. Reindeer Biology will initiate and complete clinical trials as soon as possible, bringing hope for a cure for myasthenia gravis patients in China.

 

 

 

In addition, according to the review, Aijiamod introduced by Zaiding Pharmaceutical from Argenx is currently an approved FcRn antagonist for the market in China, and also an FcRn antagonist that can be reimbursed by medical insurance in China. It is used to treat adult systemic myasthenia gravis patients with positive acetylcholine receptor (AChR) antibodies.

 

 

 

In March 2023, Hebo Pharmaceuticals released phase III trial data for the treatment of generalized myasthenia gravis (gMG) with batolizumab. The results showed that the primary and key secondary endpoints had been achieved, and the treatment was generally safe and well tolerated, with no new safety signals found. However, in December 2023, Hebao Pharmaceutical suddenly announced the postponement of the Phase III clinical trial of Bartolimumab to collect other long-term safety data, and withdrew the drug's marketing application, planning to resubmit it in 2024.

 

 

 

According to the industry, traditional treatment methods for myasthenia gravis patients have significant shortcomings in symptom control, treatment side effects, and other aspects. It has been very difficult to achieve the dual standard treatment goal for a long time, which is also the current difficulty in the treatment of myasthenia gravis. Therefore, there is an urgent need for safe and effective innovative therapies for myasthenia gravis.