On December 10, Shanghai Junsai Biotechnology Co., Ltd. (hereinafter referred to as “Junsai Biotechnology”) submitted a listing application to the Hong Kong Stock Exchange. According to its prospectus, Junsai Bio is a biotechnology company dedicated to the development of innovative cell therapies and drugs for solid tumors. Its core product, GC101, is expected to become the first approved tumor-infiltrating lymphocyte (TIL) therapy. In 2023, 2024, and the first half of 2025, the company projected net losses of RMB 94 million, RMB 164 million, and RMB 98 million, respectively. The core product GC101 undergoes important testing. According to its prospectus, Junsai Bio focuses on the huge unmet clinical needs in the treatment of solid tumors and is developing the next generation of pan-solid tumor immunotherapy. According to the company, its core product GC101 is currently undergoing a pivotal Phase II clinical trial for the treatment of melanoma, with a Biologics License ...
On December 14, Zhejiang Zouli Pharmaceutical Co., Ltd. issued an announcement stating that its board of directors had approved the “Proposal on Purchasing an Asset Group and Signing an Acquisition Agreement.” The company plans to acquire a group of trace element injections held by Tibet Future Biomedical Co., Ltd. and its two wholly-owned subsidiaries for a total price (including tax) of RMB 356 million. This asset group covers core assets such as R&D and production technology data, marketing authorizations, trademarks, and patents related to the marketed “Multiple Trace Element Injection (I)” and “Multiple Trace Element Injection (II),” as well as the research and development “Multiple Trace Element Injection (III)” under development. The announcement indicates that multi-trace element injections are a major source of trace elements in parenteral nutrition, especially suitable for nutritional supplementation in special populations such as children and critically ill patients. Among them, multi-trace element injection (I) and ...
News Report – On December 13, the Phase II clinical trial initiation meeting for the hexavalent recombinant norovirus vaccine (a Class 1.1 new drug) independently developed by Vazyme Life Sciences Co., Ltd. (hereinafter referred to as “Vazyme”), a subsidiary of Grand Life Science Group Co., Ltd. (referred to as “Grand Life Science”), was successfully held at the Cenxi City Center for Disease Control and Prevention in Guangxi. According to the reporter, this vaccine is currently the fastest progressing hexavalent norovirus vaccine in global clinical development. It utilizes virus-like particle (VLP) technology and covers six globally prevalent genotypes, theoretically providing coverage for over 90% of circulating norovirus strains worldwide. Norovirus is a leading cause of acute gastroenteritis, characterized by rapid mutation, high infectivity, and fast transmission. The period from October to March each year marks the peak season for norovirus infection in China. At present, there are no specific antiviral drugs ...
Junshi Biosciences (688180.SH): JS212 Clinical Trial Application for Advanced Solid Tumors Approved by US FDA BEIJING, December 14 – Junshi Biosciences (688180.SH) announced late evening on December 14 that the company recently received notification from the U.S. Food and Drug Administration (FDA) that its Investigational New Drug (IND) application for JS212, an EGFR/HER3 bispecific antibody-drug conjugate (ADC), has been approved for the treatment of advanced solid tumors. According to the announcement, JS212 is a recombinant humanized bispecific ADC targeting the epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 3 (HER3). It is primarily intended for the treatment of advanced malignant solid tumors. The company stated that the drug can bind to EGFR or HER3 to exert tumor-inhibiting effects, is expected to be effective against a broader range of tumors such as lung cancer and colorectal cancer, and may potentially overcome drug resistance issues. Preclinical studies showed that ...
InnoCare Announces NMPA Approval of China’s First Self-Developed New Generation TRK Inhibitor, Zoleretinib (ICP-723), for NTRK Fusion-Positive Solid Tumors December 11, 2024 – InnoCare Pharma (stock code: 09969.HK, 688428.SH) announced late evening on December 11 that the National Medical Products Administration (NMPA) has approved its self-developed, new-generation TRK inhibitor, Ichinoclax (Zoleretinib, ICP-723). The drug is indicated for the treatment of adult and adolescent patients aged 12 years and older with locally advanced or metastatic solid tumors that harbor a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. This marks Zoleretinib as the first self-developed new-generation TRK inhibitor in China [1]. NTRK gene fusions are found in a variety of tumor types, having been identified in over 26 different solid tumors to date. In China, an estimated 6,500 new cases of NTRK fusion-positive tumors occur annually. These patients typically face short survival periods, rapid disease progression, and high disability rates. Due to ...
Every Cabbage AI Express (NBD AI Express): An investor asked a question on the investor interaction platform: “Hello, Board Secretary. I saw that Chutian Technology mentioned that the vaccine appointment channels opened and immediately sold out. Is this a true reflection of the current influenza vaccine market? If so, why have the stock market performances of the company and its subsidiaries been lukewarm?” Hualan Bio (002007.SZ) replied on the investor interaction platform on December 11th that, according to public data from the National Institutes for Food and Drug Control (NIFDC), the company has obtained lot release approval for 55 batches of influenza vaccines so far this year, ranking among the top domestically in terms of the number of approved batches. Since October, and especially November, public awareness of influenza vaccination has significantly increased. Demand orders from CDCs (Centers for Disease Control and Prevention) across the country have risen significantly compared ...
On December 8, Zhaohui Bio-B (02627.HK) announced that the company recently initiated Phase III clinical trials for its lyophilized human rabies vaccine (human diploid cell). The development of this vaccine aims to target three immunization schedules. A new drug clinical trial license was approved by the National Medical Products Administration of the People’s Republic of China (NMPA) in November 2022, followed by the approval of supplementary clinical trial applications for the Zagreb (four-dose) and simplified four-dose regimens in April 2023. The company completed the Phase I clinical trial of this investigational vaccine in October 2024. Rabies is a serious viral disease caused by the rabies virus, and appropriate vaccination can effectively prevent it. Rabies vaccines developed using human diploid cells are recommended by the WHO as the “gold standard” due to their favorable safety characteristics. Although the company demonstrated good safety in the Phase I clinical trials, the announcement also ...
This week, the nine-valent HPV vaccine of Wantai Biological was launched in Shanghai. The curtain has risen on the competition between Wantai Biological and Merck in the field of nine-valent HPV vaccines. The HPV vaccine is of great significance in preventing diseases such as cervical cancer and saving tens of thousands of lives. At present, only these two enterprises have launched the nine-valent vaccine in China. Previously, Merck had monopolized this market for seven years, taking away the most profitable portion of it. Now, Merck’s agent, Zhifei Biological, has accumulated too much inventory. Wantai Bio has leveraged the price-sensitive market with lower prices. But now the commercial returns of vaccine enterprises are becoming increasingly unclear, especially for those whose products are still in the clinical stage. The problem facing some enterprises is whether the ongoing clinical trials of bivalent and nonavalent HPV vaccines should be halted. The nine-valent vaccine is ...
In a pivotal registrational clinical trial for patients with NTRK fusion-positive solid tumors, zoletrazinib demonstrated efficacy and safety as a broad-spectrum anticancer drug regardless of tumor type. The registrational clinical trial results showed an overall response rate (ORR) of 89.1%, a disease control rate (DCR) of 96.4%, a 24-month progression-free survival (PFS) rate of 77.4%, and a 24-month overall survival (OS) rate of 90.8%. As a new generation TRK inhibitor independently developed in China, zoletrazinib is more effective than first-generation TRK inhibitors. It not only provides long-term deep remission but also exhibits strong penetrating brain activity and good overall safety. Furthermore, data shows that it can overcome resistance to first-generation TRK inhibitors. The once-daily oral administration of two tablets also offers greater convenience to patients. Professor Zhang Yizhuo of Sun Yat-sen University Cancer Center believes that NTRK fusion-positive tumors often progress rapidly and have limited treatment options. Zoletratinib has demonstrated ...
The latest entrants are Kolen Biotech and Crescent. Recently, the two companies reached a unique licensing agreement, mutually introducing each other’s core pipeline assets and jointly joining the PD-1/VEGF+ADC development camp. The collaboration between Kelun Biotech and Crescent can be seen as a small and medium-sized player quickly following the lead of giants in this game. Core players such as BioNTech/BMS, 3SBio/Pfizer are laying out their strategies and competing in this field. It is not difficult to see from their clinical development strategies that the combination of PD-1(L1)/VEGF bispecific antibodies and ADCs is upgrading from “exploration” to “standard”. Just a few months ago, global pharmaceutical companies were hunting down PD-(L)1/VEGF bispecific antibodies, driving up the prices of these assets. Now, with the trend of PD-(L)1/VEGF bispecific antibodies accelerating their iteration into monoclonal antibodies confirmed, MNCs have been aggressively pursuing these acquired assets, and the “battleground” has shifted to the competition ...
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