Shanghai Junshi Biosciences Co Ltd

Our innovative therapy, ongericimab, has received NDA approval from the NMPA in China for treating primary hypercholesterolemia and mixed dyslipidemia (in combination with statins)! Cardiovascular disease is the leading cause of death in China, and despite current treatments, many patients with atherosclerotic cardiovascular disease (ASCVD) struggle to achieve optimal low-density lipoprotein cholesterol (“LDL-C”) levels. Ongericimab is a recombinant human anti-PCSK9 monoclonal antibody that has demonstrated its efficacy and safety in two pivotal Phase 3 clinical trials, JS002-003 and JS002-006: - JS002-003 study: Compared to placebo, ongericimab lowered LDL-C levels by more than 60% while also improving other blood lipid parameters. - JS002-006 study: Compared to placebo, patients receiving ongericimab via PFS or AI devices saw a 70% reduction in LDL-C levels. Ongericimab offers a valuable new option to a growing public health crisis, and the NMPA’s approval will give hope for those at high risk. With ongericimab as our 5th commercial product, our product portfolio has expanded from oncology and infectious disease into chronic metabolic diseases. We look forward to bringing more life-changing therapies to patients in need! #cardiovasculardisease #medicalinnovation #monoclonalantibody #pcsk9 #ongericimab #junshi #topalliance

Along with its recent approval in India, toripalimab has also received marketing approval in China’s Hong Kong SAR for the treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC)! The 2 indications include: 1.     Toripalimab + cisplatin & gemcitabine for adults with metastatic or recurrent, locally advanced NPC. 2.     Toripalimab (single agent) for adults with recurrent unresectable/metastatic NPC who experienced disease progression after platinum-containing chemotherapy. NPC is a challenging cancer with limited treatment options, and toripalimab has demonstrated remarkable survival benefits in the JUPITER-02 and POLARIS-02 clinical trials. This newest milestone makes toripalimab the first and only treatment for NPC approved in China’s Hong Kong SAR, giving many NPC patients there access to innovative immunotherapy. As China’s Hong Kong SAR joins the growing list of regions where toripalimab is approved, we continue our mission to deliver breakthrough therapies to more patients around the globe! Learn more: https://lnkd.in/gC58Ej-d #cancerinnovation #nasopharyngealcarcinoma #immunotherapy #toripalimab #junshi #topalliance 

Toripalimab has received marketing approval in India for all lines of treatment for recurrent or metastatic nasopharyngeal carcinoma (NPC)! The 2 indications include: 1.     Toripalimab + cisplatin & gemcitabine for adults with metastatic or recurrent, locally advanced NPC. 2.     Toripalimab (single agent) for adults with recurrent unresectable/metastatic NPC who experienced disease progression after platinum-containing chemotherapy. NPC is one of the most common types of head and neck cancers in the world, with more than 120,000 new cases in 2022 alone. Due to the location of the primary tumor, surgery is rarely an option. In the JUPITER-02 and POLARIS-02 studies, toripalimab demonstrated significant survival benefits and antitumor activity in patients. Toripalimab’s approval in India was supported by these groundbreaking study results, and toripalimab has become the 1st and only NPC immunotherapy treatment approved in India. Learn more: https://lnkd.in/gC58Ej-d #nasopharyngealcarcinoma #npctreatment #medicalinnovation #immunotherapy #cancertreatment #oncology #toripalimab #junshi #topalliance 

Dr. Patricia Keegan discusses our groundbreaking study with OncoDaily at this year’s ASCO! Dr. Keegan, CMO of TopAlliance Biosciences Inc, shared insights on the use of neoadjuvant chemotherapy with #toripalimab for gastric cancer and the promising findings that could transform future treatment strategies. A special thank you to OncoDaily for conducting this wonderful interview and sharing our work with the oncology community! For the full interview and article: https://lnkd.in/eK-ARgBP (TopAlliance Biosciences Inc is our US subsidiary with 2 innovation centers located in Maryland and California.) #ASCO2024 #oncology #gastriccancer #immunotherapy #toripalimab

We are proud to share that toripalimab (Loqtorzi®) has received official approval from the European Commission for use across all 27 EU countries, Iceland, Norway, and Liechtenstein! The EC has approved Loqtorzi (toripalimab) for the following two indications: 1.     Toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with recurrent, not amenable to surgery or radiotherapy, or metastatic nasopharyngeal carcinoma (NPC)  2.     Toripalimab in combination with cisplatin and paclitaxel for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic oesophageal squamous cell carcinoma (ESCC). NPC and ESCC are malignant cancers with high incidence rates in Asia, and 2022 saw over 120,000 newly diagnosed NPC cases and 511,000 new esophageal cancer (EC) cases worldwide. This approval marks a significant milestone in the fight against cancer, particularly for patients in Europe who have long awaited effective treatment options. Join us in celebrating this monumental step as we continue making strides in improving global cancer care! #loqtorzi #toripalimab #nasopharyngealcarcinoma #esophagealcancer #escc #globalhealthcare #medicalinnovation #cancertreatment #junshi #topalliance

We are excited to share that TopAlliance Biosciences Inc’s CMO, Dr. Patricia Keegan, recently spoke at the VICTORI meetings. Hosted by our wonderful collaborator, Dr. Reddy's Laboratories, VICTORI was held in Mumbai, Delhi, and Jaipur. The meetings provided a great platform for Dr. Keegan to share key insights on toripalimab, also known as Zytorvi in India and Loqtorzi in the US. Toripalimab is a leading anti-PD-1 monoclonal antibody that promotes the immune system’s ability to target and destroy tumor cells. With 10 approved indications in China, toripalimab has also received US FDA approval for nasopharyngeal carcinoma (NPC) and is under review in Europe, Australia, and Singapore. Together with Dr. Reddy’s Laboratories, we are committed to advancing global healthcare and making a difference for patients across the globe. TopAlliance Biosciences Inc is our US subsidiary with 2 innovation centers located in Maryland and California. #immunotherapy #globalhealthcare #medicalinnovation #toripalimab #zytorvi #loqtorzi #drreddy #victori

We at Shanghai Junshi Biosciences Co Ltd and TopAlliance Biosciences Inc wish you a Happy Mid-Autumn Festival! As we celebrate the beauty of the harvest moon, we also celebrate unity, gratitude, and progress. Driven by our commitment to combining cutting-edge innovation with care and compassion, we will continue striving to improve lives and bring hope to people around the world. May this festive season bring you happiness, health, and well-being! TopAlliance Biosciences Inc is our US subsidiary with 2 innovation centers in Maryland and California. #midautumnfestival #healthcare #medicalinnovation #junshi #topalliance  

Another sNDA for Toripalimab Accepted—the NMPA has accepted our supplemental new drug application for toripalimab as a first-line treatment for unresectable/metastatic melanoma. Melanoma is a highly aggressive form of skin cancer with a rising incidence rate. In China, first-line treatment options are limited to chemotherapy, and there is an urgent need for more effective therapies. Toripalimab has already made a significant impact in second-line and beyond treatments, and during the MELATORCH study that compared the efficacy and safety of toripalimab with dacarbazine, toripalimab as the first-line treatment for unresectable/metastatic melanoma significantly prolonged the PFS of patients. We hope that with this sNDA, we can offer Chinese patients a groundbreaking first-line immunotherapy option. #melanoma #cancertreatment #immunotherapy #toripalimab #snda #nmpa #medicalinnovation #junshi #topalliance 

LOQTORZI® receives Positive Opinion in Europe—The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion on our marketing authorization application for toripalimab (LOQTORZI®)! The CHMP recommends approval for toripalimab for two indications: 1. Toripalimab + cisplatin and gemcitabine for 1st line treatment of adult patients with recurrent, not amenable to surgery or radiotherapy, or metastatic nasopharyngeal carcinoma (NPC); 2. Toripalimab + cisplatin and paclitaxel for the 1st line treatment of adult patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) regardless of PD-L1 status. This milestone brings us one step closer to offering new hope to patients in Europe. If approved, toripalimab will be the first and only drug for the treatment of NPC and the only first-line treatment for advanced or metastatic ESCC regardless of PD-L1 status in all 27 member states of the European Union! Learn more: https://lnkd.in/ejnrfbBb #loqtorzi #toripalimab #firstinclass #nasopharyngealcarcinoma #esophagealcarcinoma #oncology #ema #chmp #breakthroughtherapy #cancertreatment #medicaladvancement #healthcareinnovation #globalhealth 

sNDA Submitted for New Liver Cancer Treatment—The NMPA has accepted our sNDA for toripalimab combined with bevacizumab as a first-line treatment for hepatocellular carcinoma (HCC)! Liver cancer remains a considerable challenge worldwide, and the majority of cases are diagnosed at an advanced stage. In 2022, China reported 368,000 new cases (42.4% of global cases) and 317,000 deaths (41.7% of global cases) due to liver cancer. The HEPATORCH study evaluating toripalimab plus bevacizumab versus sorafenib for HCC demonstrated significant survival benefits. Having been approved for 10 indications, toripalimab has again showcased its versatility and efficacy in tackling cancer, and this new sNDA approval will greatly benefit HCC patients. Learn more: https://lnkd.in/eUcc5rib #toripalimab #livercancer #hepatocellularcarcinoma #cancertreatment #medicalinnovation #oncology #healthcare #topalliance #junshibiosciences