Remegen announced the data of a domestic phase II clinical study for the treatment of myasthenia gravis

Remegen Biologics Co.
, Ltd.
(hereinafter referred to as "Remegen" or the "Company"), a global innovative biopharmaceutical company, (stock code: 9995.
HK, SHA: 688331) recently announced the data of its proprietary novel fusion protein, Telitacicept, in a phase II clinical study in China for the treatment of myasthenia gravis (MG), and obtained positive results
.

Myasthenia gravis (MG) is a rare, chronic autoimmune disease, caused by autoantibodies against acetylcholine receptors, muscle-specific kinases or other acetylcholine receptor-related proteins on the postsynaptic membrane, resulting in impaired neuromuscular junction transmission, which can affect eye movement, swallowing, speech, activity and respiratory function to varying degrees, about 85% of patients will have symptoms other than eye muscles, develop into generalized myasthenia gravis (GMG), and even myasthenic crisis, which has been included in China's " First Rare Disease Catalogue.

At present, the main treatment of the disease includes cholinesterase inhibitors, glucocorticoids and immunosuppressants, but there are still some patients who cannot fully and effectively control the disease due to drug efficacy, tolerance or contraindications to use, and there are a large number of unmet clinical needs
.

In this multicenter, randomized, open-label Phase II clinical study, participants are adult patients diagnosed with myasthenia gravis (MG) who have tested positive for acetylcholine receptor antibodies and are receiving standardized medical treatment
.
The weekly cycle was 24 weeks, and a total of 41 patients were enrolled, of whom 29 were randomly assigned to the trial (14 to tetacept 160 mg and 15 to 240 mg) and all completed the full course of treatment
.
The primary efficacy endpoint of the study was the difference
in the quantitative myasthenia gravis score (QMG) compared to baseline at week 24.

The results of the study showed an average reduction of 7.
7 points in the tetacept 160mg group and a decrease of 9.
6 points in the tetacept 240mg group (a 3-point decrease in QMG score indicates clinical significance, and a decrease of more than 5 points indicates obvious efficacy).

The study showed that tetacept can significantly improve the patient's condition and show a good safety profile
in the treatment of myasthenia gravis (MG).

Dr.
Jianmin Fang, CEO and Chief Scientist of Remegen, said: "As a fully integrated biopharmaceutical company, we are committed to discovering and developing innovative and differentiated biologics for the treatment of autoimmune, oncology and ophthalmic diseases, and our vision is to become a leader in the global biopharmaceutical industry, and we are accelerating this goal
.
”

"Leveraging our robust R&D platform, we have developed more than a dozen drug candidates, seven of which are in clinical study for more than 20 indications
.
The latest phase II clinical study results show that the use of tatacept for the treatment of myasthenia gravis in Chinese patients is expected to further solve the unmet clinical needs
of countless patients in China and around the world.
”

About Telitacicept (RC18)

Telitacicept (RC18, brand name: Telitacicept, brand name: Taiai ^®) is a proprietary novel fusion protein
used by Remegen for the treatment of autoimmune diseases.
It consists of the extracellular domain of human transmembrane activators and calcium modulators and cyclosporine ligand interacter (TACI) receptors and the crystalline (Fc) domain of human immunoglobulin G (IgG
).

Tetacept targets two classes of cell signaling molecules that are critical for B lymphocyte development: B lymphocyte-stimulating factor (BLyS) and proliferation-inducing ligand (APRIL), effectively reducing B-cell-mediated autoimmune responses, which are implicated in
a variety of autoimmune diseases.

In March 2021, Tetacept received conditional marketing approval from China's National Medical Products Administration (NMPA) for the treatment of systemic lupus erythematosus (SLE).

In September 2022, Remegen obtained preliminary results from a Phase III validation study of tatacept for the treatment of systemic lupus erythematosus (SLE) in China, which are consistent
with the results of the early-stage study.
Currently, Remegen is actively conducting phase II or III clinical studies of tetacept for the treatment of autoimmune diseases in a variety of other indications to address the large unmet medical needs
in this therapeutic area.