February 1, 2025
Source: drugdu
91
According to the Hong Kong Stock Exchange's disclosure on January 21, Shanghai Baoji Pharmaceutical Co., Ltd. (hereinafter referred to as "Baoji Pharmaceuticals") submitted a listing application to the Hong Kong Stock Exchange, with CITIC Securities and Haitong International as joint sponsors.
Since its establishment in 2019, the company has always focused on the research and development of large-scale biological drugs, and is committed to improving treatment standards by replacing biochemical extraction products derived from animal organs, blood or urine, or upgrading existing treatments in other ways. According to Frost & Sullivan, the combined potential market size of these four areas will exceed RMB 50 billion in 2033: (i) large-volume subcutaneous administration, (ii) antibody-mediated autoimmune diseases, (iii) assisted reproductive drugs, and (iv) transformative products that replace traditional biochemical products with recombinant biopharmaceuticals.
As of the Latest Practicable Date, the Company has built a differentiated R&D pipeline covering the above four therapeutic areas, consisting of five clinical-stage investigational drugs (including the Company's three core products KJ017, KJ103 and SJ02) and seven preclinical products. With respect to each core product, (i) KJ017 is a highly glycosylated recombinant human hyaluronidase developed for rapid, high-volume subcutaneous administration of combination drugs; (ii) KJ103 is an innovative recombinant immunoglobulin G (IgG) degrading enzyme used to treat a variety of immune diseases and conditions driven by pathological IgG activity. The Company is currently conducting clinical trials at different stages to evaluate the effects of KJ103 in the fields of renal transplant desensitization, anti-glomerular basement membrane disease (anti-GMB disease) and Guillain-Barré syndrome (GBS); and (iii) SJ02 is a long-acting recombinant human follicle stimulating hormone-CTP fusion protein (FSH-CTP) designed to be used in combination with a gonadotropin-releasing hormone (GnRH) antagonist for controlled ovarian stimulation (COS). All of the Company's core products have entered the late clinical stage or NDA registration stage in China. In addition, the Company is actively promoting a variety of other pipeline products, especially innovative recombinant biologics that are transformative alternatives to traditional biochemical extract drugs, including KJ101 and BJ044.
As of the Latest Practicable Date, KJ017 is the first and only recombinant human hyaluronidase in China to enter the NDA stage. With its excellent clinical efficacy, it is expected to take the lead in China's huge untapped market. Globally, the recombinant human hyaluronidase market is expected to grow from US$675 million in 2023 to US$2.980 billion in 2028 and further to US$10.385 billion in 2033, while the Chinese market is estimated to increase from RMB 1.939 billion in 2028 to RMB 7.495 billion in 2033. For recombinant human hyaluronidase monotherapy, the global market is expected to increase from US$111 million in 2023 to US$559 million in 2028 and US$1.097 billion in 2033, while the Chinese market is expected to reach RMB 663 million in 2028 and increase to RMB 1.532 billion in 2033.
To meet the large unmet needs associated with various antibody-mediated autoimmune diseases, the company independently developed KJ103, an innovative IgG degrading enzyme. This is the world's first and only low-immunogenic IgG degrading enzyme to reach the late clinical stage. KJ103 targets IgG antibodies in the blood and tissues and degrades them, thereby inhibiting pathological IgG-mediated immune responses that cause various immune diseases. The company is also actively exploring other candidate drugs with synergistic effects in this field, including patented anti-enzyme degradation subcutaneous antibodies and IgM degrading enzymes. KJ103 has entered Phase II/III trials in China for desensitization of patients with high human leukocyte antigen (HLA) sensitization to achieve kidney transplantation. Phase II has been completed and is expected to become China's first IgG degrading enzyme, filling this critical gap in transplant medicine. In November 2024, it received breakthrough therapy recognition for this indication from the National Medical Products Administration. KJ103 is expected to be used to treat acute autoimmune diseases caused by a large number of pathological autoantibodies and has a huge market size. The company has completed a Phase I safety and exploratory clinical trial of KJ103 in healthy subjects in New Zealand. Based on this trial, the company can conduct a follow-up clinical trial in the United States for acute autoimmune diseases caused by pathological IgG and desensitization treatment of patients with high HLA sensitization. The company plans to submit an IND application for a Phase II trial of KJ103 for the treatment of GBS to the U.S. Food and Drug Administration (FDA) in the first half of 2026.
https://finance.eastmoney.com/
By editoryour submission has already been received.
OK
Please enter a valid Email address!
Submit
The most relevant industry news & insight will be sent to you every two weeks.