Key Milestone: The first patient successfully dosed with the candidate drug SR419 for peripheral neuropathic pain

SHANGHAI,Sept. 21,2020 --Shanghai SIMR Biotechnology Co.,Ltd. (hereinafter referred to as "SIMR" or "Company") announced that,the clinical trial in patients with peripheral neuropathic pain has been initiated for the candidate drug SR419,and the first patient has been successfully dosed.

The current clinical trial is the first study for SR419 in the patient population,purposing to explore the efficacy,safety,tolerability and pharmacokinetics of SR419 in patients with neuropathic pain.

Dr. Kai Wu,Co-CEO and Head of Clinical Development of SIMR,said: "Previous clinical results demonstrated that SR419 was safe and tolerable with good pharmacokinetic characteristics,which ensured the success to initiate the current trial in the patient population."

Dr. Shuai Li,founder and chairman of SIMR,said: "The socio-economic burden caused by chronic pain is huge. For example,the overdose of opioids causes more than 100,000 deaths worldwide every year. Based on the available preclinical and clinical data,SR419 has the potential to replace opioids,so we very much look forward to the outcome from this trial for SR419!

About SR419

SR419 is a candidate drug of novel mechanism for the treatment of peripheral neuropathic pain,discovered and developed by SIMR. It has successfully completed the first-in-human phase I clinical trial. SR419 has the potential of strong analgesic efficacy and no CNS side effects.

About peripheral neuropathic pain

Peripheral neuropathic pain is the pain caused by damage or pathological changes of peripheral nerves,including post-herpetic neuralgia,diabetic peripheral neuropathy,chemotherapy-induced peripheral neuropathy,and postoperative peripheral neuropathy. Epidemiological data show that the incidence of neuropathic pain in the general population is about 8%. Diabetic peripheral neuropathy affects about 50% of diabetic patients,and chemotherapy-induced peripheral neuropathy affects nearly 60% of cancer patients after chemotherapy. As the standard treatment for neuropathic pain,the annual global sales of pregabalin (Lyrica) has reached about $3 to $5 billion in the past 5 years,but its efficacy is not ideal,with nearly 50% of patients not experiencing effective pain relief after treatment. Therefore,there are significant unmet medical needs for this disease.

About SIMR

SIMR is an innovation-oriented biopharmaceutical company dedicated to the discovery and development of new drugs for pain and other nervous system diseases.

For more information on SIMR,please visit http://www.simrbio.com.

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