Suzhou Junjing BioSciences Co., Ltd.

SHANGHAI, China, Aug. 25, 2022 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced today that Suzhou Junjing Biomedical Technology Co., Ltd., a company jointly invested by Junshi Biosciences and Wigen Biomedicine Technology (Shanghai) Co., Ltd., has received a notice from the U.S. Food and Drug Administration (the “FDA”) concerning the approval of the investigational new drug (“IND”) application for XPO1 inhibitor WJ01024 tablets (product code: “JS110”) by the FDA. So far, 6 innovative drugs in Junshi Biosciences’ pipeline have obtained IND approval from the FDA, and with this newest addition, there are now 7. About JS110 JS110 is a small molecule inhibitor of the nuclear export protein XPO1, which is clinically intended for the treatment of patients with advanced tumors. According to the results of pre-clinical studies, JS110 specifically blocks the function of XPO1, inhibits the nuclear export of various tumor suppressor proteins including p53, and strengthens the functions of tumor suppressor proteins. In vitro, JS110 inhibits the growth and induces death of various tumor cells; in animal tumor models, JS110 monotherapy and combination therapy can both inhibit the growth of various blood and solid tumors. Due to its unique mechanism of action, the development of JS110 may potentially bring new treatment options to patients with advanced tumors. In April 2021, the IND application for JS110 was approved by the National Medical Products Administration. At present, the Phase I clinical trial of JS110 is in progress in the People’s Republic of China (NCT04991129). Junshi Biosciences currently owns the world-wide exclusive production rights, licensed production rights and sales rights for JS110. About Junshi Biosciences Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative therapeutics. The company has established a diversified R&D pipeline comprising over 50 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for anti-PD-1 monoclonal antibody in China. Its first-in-human anti-BTLA monoclonal antibody for the treatment of various cancers was the first in the world to be approved for clinical trials by the FDA and NMPA and has since entered Phase Ib/II trials in both China and the US. Its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA. In the face of the pandemic, Junshi Biosciences’ response was strong and immediate, joining forces with Chinese and international scientific research institutions and enterprises to develop an arsenal of drug candidates to combat COVID-19, taking the initiative to shoulder the social responsibility of Chinese pharmaceutical companies by prioritizing and accelerating COVID-19 R&D. Among the many drug candidates is JS016 (etesevimab), China’s first neutralizing fully human monoclonal antibody against SARS-CoV-2 and the result of the combined efforts of Junshi Biosciences, the Institute of Microbiology of the Chinese Academy of Science and Lilly. JS016 administered with bamlanivimab has been granted Emergency Use Authorizations (EUA) in over 15 countries and regions worldwide. As of December 3 2021, over 700,000 patients have been treated with bamlanivimab or bamlanivimab and etesevimab, potentially preventing more than 35,000 hospitalizations and at least 14,000 deaths. Meanwhile, VV116, a new oral nucleoside analog anti-SARS-CoV-2 drug designed to hinder virus replication, is in global Phase III clinical trials. A Phase III clinical study (NCT05341609) comparing the efficacy and safety of VV116 versus nirmatrelvir/ritonavir (“PAXLOVID”) for patients with mild to moderate COVID-19 who are at high risk for progression to severe COVID-19, has reached its pre-specified primary endpoint and secondary efficacy endpoint. The study results show that compared to PAXLOVID, VV116 provided patients with a shorter median time to sustained clinical recovery, while achieving statistical superiority. The JS016 and VV116 programs are a part of the company’s continuous innovation for disease control and prevention of the global pandemic. Junshi Biosciences has more than 3,100 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc). For more information, please visit: http://junshipharma.com.

Sarah Silbiger/Getty Images The FDA is keeping busy as summer winds down, with approvals, Orphan Drug Designations and other actions. Here’s what the agency has been up to this week. August 26 Incyte announced that the FDA has approved Pemazyre (pemigatinib) for the treatment of relapsed or refractory myeloid/lymphoid neoplasms with FGFR1 rearrangements. The drug is a selective FGFR inhibitor. The approval marks the first and only targeted treatment for this indication, Incyte stated. It is also the second approval for Pemazyre, which already has FDA authorization for adults previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or other rearrangement. Inhibikase Therapeutics received the go-ahead from the FDA to launch a study of IkT-001Pro for chronic myelogenous leukemia. IkT-001Pro is a prodrug formulation of imatinib mesylate and is designed to improve the safety of Gleevec (imatinib). Suzhou Junjing Biomedical Technology Co.’s IND for JS110 was approved by the FDA. The drug is a small molecule inhibitor of the nuclear export protein XPO1 for advanced tumors. August 25 Iovance Biotherapeutics initiated a rolling BLA submission to the FDA for li a tumor infiltrating lymphocyte therapy, in advanced melanoma patients. The therapy is intended for patients who have progressed on or after previous anti-PD-1/L1 therapy, are BRAF mutation positive and have previously received BRAF or BRAF/MEK inhibitor therapy. Century Therapeutics received the green light from the FDA to proceed with its ELiPSE-1 trial of CNTY-101 in patients with relapsed or refractory CD19 positive B-cell malignancies. CNTY-101 is an allogeneic cell therapy engineered with four complementary functionalities, including a CD19 CAR for tumor targeting, IL-15 support for enhanced persistence, Allo-Evasion technology to prevent host rejection and enhanced persistence. It also has a safety switch to eliminate the drug if necessary. Therapeutic Solutions International filed an amendment with the FDA regarding its currently open Phase III trial. The company is requesting that eligibility be expanded to include all patients suffering from acute respiratory distress syndrome (ARDS) regardless of cause. It is currently only recruiting patients with advanced ARDS caused by COVID-19. B.More reported the FDA approved its IND application to launch a Phase IIb trial of SYNP-101 (psilocybin) for patients with alcohol use disorder. The trial is expected to start in early 2023. August 24 Calyptus Pharmaceuticals’s Abbreviated NDA (ANDA) for Brovana (arformoterol tartrate inhalation solution) was approved by the FDA. The drug, co-developed with VistaPharm, is indicated for the long-term, twice-daily maintenance treatment of bronchoconstriction in COPD patients, including chronic bronchitis and emphysema. Surgalign Holdings reported FDA 510(k) clearance of the Cortera Spinal Fixation System. It will integrate the system with the HOLO Portal surgical guidance system. Tachyon Therapeutics received the go-ahead from the FDA to initiate a Phase Ia trial of TACH101 for advanced solid tumors. The drug is a KDM4 inhibitor. Ainos submitted an IND to the FDA for a Phase II trial of Veldona, a low-dose oral interferon-alpha formulation, for mild symptoms related to COVID-19. August 23 Foghorn Therapeutics announced that the FDA placed a full clinical hold on a Phase I dose escalation study of FHD-286 in relapsed or refractory acute myelogenous leukemia and myelodysplastic syndrome. The drug is a BRG1/BRM inhibitor. The hold was based on a death in the study, but it has not been determined if it is related to the therapy or the disease. Jaguar Health reported the FDA has accepted its application for review for Orphan Drug Designation for Crofelemer. The drug is being evaluated for a rare congenital diarrheal disorder, microvillus inclusion disease (MVID). K36 Therapeutics received the green light from the FDA to run a Phase I trial of KTX-1001 in patients with relapsed and refractory multiple myeloma, enriching for patients with the t(4;14) genetic translocation. KTX-1001 is a small molecule methyltransferase inhibitor of the multiple myeloma SET domain known as MMSET. Abbott Laboratories’ Proclaim Plus spinal cord stimulation system featuring FlexBurst360 therapy was approved by the FDA. The product offers pain coverage across up to six areas of the trunk and/or limbs. Synlogic reported the FDA granted Fast Track designation to its SYNB1353 for the treatment of homocystinuria. iECURE announced the FDA has granted Rare Pediatric Disease Designation to GTP-506. The drug is being developed to treat Ornithine Transcarbamylase (OTC) deficiency. August 22 Pfizer was instructed by the FDA to run a clinical trial to evaluate an additional course of its antiviral combination therapy Paxlovid in people who experienced COVID-19 rebound infections. The company is expected to have initial data by Sept. 30, 2023. Pharvaris reported the FDA has placed a clinical hold on the trials of PHA121 under two Pharvaris INDs for treatment of hereditary angioedema (HAE). The hold is based on reviews of nonclinical data. Ocelot Bio’s OCE-205 received Orphan Drug Designation from the FDA for treatment of hepatorenal syndrome. It is currently enrolling patients in a Phase II trial of the drug in hepatorenal syndrome with acute kidney injury. Thermedical received the green light from the FDA to run a trial for SERF ablation to treat ventricular tachycardia patients resistant to conventional treatment. SERF ablation with the Durablate catheter will be the focus of the study. DynamiCure was cleared by the FDA to run a Phase I trial of DC-6001, a therapeutic antibody against CD93, in adults with a range of advanced cancers. Insulet received clearance of its Omnipod 5 Automated Insulin Delivery System for children aged two years and older with Type 1 diabetes. Minerva Neurosciences submitted a New Drug Application to the FDA for roluperidone for negative symptoms in patients with schizophrenia.