《SINEW PHARMA INC.》Company establishment.

Hepatoxicity-free new formulation technology platform received the “Academic Startup Seed Enterprise Award” of the 11th National Innovation Award.

Signed the license-in contract on pain and liver disease-related technologies with the National Science and Technology Council and the inventor.

Received the approval letter for the “Biotech and New Pharmaceutical Capital Increase and Expansion Investment Program” from the Industrial Development Bureau, Ministry of Economic Affairs (MOEA).

Public listed on Taiwan OTC market (stock code 6634.TWO).

SNP-610(MASH new drug) received approvals from US Food and Drug Administration (US FDA) and Taiwan Food and Drug Administration (TFDA) for Phase II clinical trial.

SNP-820, antidote for acetaminophen-induced hepatotoxicity, received approval from TFDA for Phase II clinical trial.

Received outstanding biomedical enterprise of the 14th National Brand Yushan Award.

“MASH new drug and hepatotoxicity-free analgesic drug” received the 14th National Innovation Award.

SNP-610 received grant from the Ministry of Economic Affairs A+ Industrial Innovation R&D Program for “Fast Track Clinical Trial Protocol”.

SNP-810 as hepatotoxicity-free acetaminophen painkiller was selected for oral presentation at the 16th American Society of Regional Anesthesia and Pain Medicine (ASRA) Congress.

SNP-6 series of MASH new drugs was accepted for publication in the international conference of the 1st NAFLD Summit held by the European Association for the Study of the Liver (EASL).

Invited to attend J.P. Morgan 36th Annual Healthcare Conference.

Received the “Certificate of Completion of Biotech and New Pharmaceutical Capital Increase and Expansion Investment Program” from the Department of Economic Development, Taipei City Government.

SNP-820 received orphan drug designation from TFDA.

A collaboration agreement for SNP-810 was signed with a top pharma company.

Approved & designated as a “biotech and new pharmaceutical company” by MOEA under the “Act for the Development of Biotech and New Pharmaceuticals Industry” with eligibility for investment incentive.

SNP-810 received approvals for both US FDA OTC monograph and TFDA generic drug registration.

SNP-630, MASH new composition new drug, received approval from TFDA for Phase I clinical study.

A collaboration agreement for SNP-810 was signed with another top pharma company.

Completed cash capital increase of NT$1.2 billion (around USD$38 million).

SNP-810 received the final toxicology report from Charles River Laboratories, proving that SNP-810 is free of hepatotoxicity.

SNP-810 received TFDA approval to proceed the clinical study at the dosage level exceeding the maximum recommended one of acetaminophen label.

SNP-810 in combination with a non-addictive analgesic drug for management of moderate-to-severe pain received TFDA approval for the clinical study in patients undergoing knee replacement.

SNP-630 and its active metabolites (i.e., SNP-610) have demonstrated significant anti-inflammatory and anti-fibrosis efficacy from animal studies as well as the Phase II POC study for SNP-610. The results were accepted for presentation by American Association of Pharmaceutical Scientist - AAPS 2022 PHARMSCI 360 in Boston.

The clinical study of SNP-810 exceeding recommended label dosage received grant from the MOEA’s A+ Industrial Innovation R&D Program for “Fast Track Clinical Trial Protocol”.

SNP-630 has completed Phase I clinical trial with Clinical Study Report, and clinical site audited by TFDA.

The clinical study of SNP-810 in combination with a non-addictive analgesic drug for management of moderate-to-severe pain has completed enrollment of patients undergoing knee replacement.

SNP-810 clinical study, testing dosages exceeding triple recommended label dosage of acetaminophen, has completed patient enrollment.

The results of the SNP-810 clinical study, testing the dosages reaching triple of the recommended label dosage of acetaminophen, were disclosed and have provided direct evidence in humans that SNP-810 has high liver safety.

The results of the SNP-810 clinical study in combination with a non-addictive analgesic drug for management of moderate-to-severe pain in patients undergoing knee replacement showed that no hepatotoxicity or serious adverse reactions related to the study drug occurred. The combination therapy demonstrated a significant synergistic effect in relieving severe pain.

Invited to attend the 8th Annual MASH Drug Development Summit in Boston (USA) to host a pre-conferece workshop and present the clinical trial results of SNP-630/610.

The mechanism of action of SNP-630/610 and the results of Phase II clinical trials, demonstrating significant anti-inflammatory and anti-fibrotic effects, have been accepted for publication in the internationally renowned SCI journal -- Journal of Translational Medicine.