On the evening of February 11th, China Securities Network reported that Shenzhou Cell announced that its holding subsidiary Shenzhou Cell Engineering Co., Ltd. (hereinafter referred to as “Shenzhou Cell Engineering”) had recently received approval from the National Medical Products Administration for the issuance of Finolizumab Injection (trade name: Anyuping) ®) The Drug Registration Certificate is used for the treatment of head and neck squamous cell carcinoma. Finolizumab is a recombinant humanized anti-PD-1 IgG4 monoclonal antibody injection independently developed by the company (project code: SCT-I10A), This is approved for the treatment of head and neck squamous cell carcinoma. Finolizumab is a functional monoclonal antibody against PD-1, which can increase the supply of T cells and inflammatory cytokines at the tumor site by blocking the binding of PD-1 to its ligand, reduce the proportion of regulatory T cells and myeloid derived suppressor cells in the tumor microenvironment, alter the tumor microenvironment, restore ...
Policy Trends The National Medical Products Administration has issued a notice regarding 26 batches of cosmetics that do not comply with regulations On February 11, the WeChat official account of the State Food and Drug Administration issued a document stating that 26 batches of cosmetics with the product label name of Yunman Bathing Lotion did not meet the requirements in the 2024 national cosmetics sampling inspection, which was inspected by Qinghai Institute for Drug Inspection and Testing and other units. Medical device approval Two first in class dual antibodies from Johnson&Johnson have been approved for market launch in China On February 11th, Johnson&Johnson announced that the marketing applications for Ruike (Evantazumab) and Tuolikuo (Taquettuzumab) have both been approved by the National Medical Products Administration. The former is the world’s first approved EGFR/c-MET bispecific antibody, while the latter is the first approved bispecific antibody drug targeting GPRC5D. GSK Mabolizumab’s new indication ...
Hansen Pharmaceuticals (002412) issued an announcement that the company recently obtained the “Drug Registration Certificate” for the chemical drug “Empagliflozin Tablets” approved and issued by the State Drug Administration. The generic name of the drug is empagliflozin tablets, the dosage form is tablets, the specification is 10mg, and the registration classification is chemical drug Class 4. According to the announcement, the drug registration standard number is YBH32972024, and the approval conclusion shows that the drug meets the registration requirements and has been approved. After obtaining the registration certificate, empagliflozin tablets can be produced and sold domestically, further enriching the company’s product line and helping to enhance market competitiveness. However, the announcement also pointed out that the future production and sales of drugs may be affected by factors such as changes in the market environment, so there is uncertainty in the profit level, and investors need to make decisions carefully. In ...
Recently, Beijing Likang Life Science and Technology Co., Ltd. (hereinafter referred to as “Likang Life Science”) independently developed a tumor neoantigen mRNA vaccine product, LK101 injection, which successfully obtained IND (clinical trial application) approval from the U.S. Food and Drug Administration (FDA). This is my country’s first tumor neoantigen mRNA vaccine product approved by the FDA, marking that my country’s innovative strength in the field of tumor immunotherapy has been internationally recognized. Based on the patient’s individual tumor-specific mutations, LK101 injection selects highly immunogenic neoantigens through high-throughput sequencing and artificial intelligence-driven antigen prediction platforms, and uses mRNA technology to encode target antigens, aiming to induce a directional immune response in the body. Compared with traditional treatments, this technology has higher accuracy and safety, and provides new ideas for the treatment of solid tumors. Two years ago, LK101 injection was approved for clinical trials in China and conducted Phase I clinical ...
On February 11, Aimi Vaccines (06660) issued an announcement that the company recently applied to the Drug Review Center of the China Food and Drug Administration for clinical trials of mRNA herpes zoster vaccines. According to the announcement, the company’s mRNA herpes zoster vaccine showed that specific T cell immunity, IgG antibody titers and membrane antigen fluorescent antibody titers were significantly higher than the commercially available recombinant subunit control vaccine in preclinical animal trials. This shows that the vaccine has obvious advantages in immune protection. In addition, the announcement mentioned that the particularity of the herpes zoster virus makes it latent for life after the initial infection, and T cell-mediated immune protection is the key to controlling viral reactivation. At present, the vaccination rate of herpes zoster vaccine in the target population is only about 0.1%, and the market potential is huge. According to industry consultants, the market size of ...
On February 8, according to the official website of NMPA, the drug marketing application for “Secukinumab Injection” (BAT2306) submitted by BioAtla was accepted. This is the first secukinumab biosimilar to be submitted for marketing. According to data, the original research secukinumab is a fully human IgG1 monoclonal antibody developed by Novartis that can selectively bind to the cytokine interleukin 17A (IL-17A) and inhibit its interaction with the IL-17 receptor. In December 2014, Secukinumab (trade name: Cosentyx) was first approved for marketing for the treatment of psoriatic arthritis. In March 2019, Secukinumab was approved for marketing in China under the trade name Cosentyx. So far, Novartis’ Secukinumab has been approved for marketing in many countries and regions around the world, including Japan, the European Union, the United States, and China, involving multiple indications such as psoriatic arthritis, psoriasis vulgaris, plaque psoriasis, ankylosing spondylitis, and pustular psoriasis, and all indications have been ...
Organiser:Informa Markets Time:July 16th – 18th, 2025 Address:8, Jalan Dutamas 2, Kompleks Kerajaan, 50480 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia Exhibition hall:Malaysia International Trade and Exhibition Product range: Medical Devices: Laboratory equipment and configurations, emergency and transportation facilities, surgical equipment, nursing and monitoring equipment, etc. Medical Technology: Orthopedic and rehabilitation technology, medical architectural facilities and technology, medical information and communication technology, etc. Pharmaceuticals: Various types of finished pharmaceuticals, medications, medical excipients, etc. Hospital Consumables: Disposable medical supplies, medical disinfectants, etc. Medical Supplies: Medical clothing and laundering technology, nutritional meal preparation equipment, medical furniture, etc. About Asia Health: The Malaysia Kuala Lumpur Medical Device Exhibition (Asia Health) is the most authoritative medical device exhibition in Southeast Asia. The market it radiates primarily includes Southeast Asian countries such as India, Malaysia, Indonesia, Vietnam, and the Philippines. Asia Health has achieved continuous success for exhibitors and visitors from all over ...
2%, 80%, 24 times – three figures, hiding the password of China’s hepatitis B treatment drug research and development from weak to strong. Breaking through the 2% survival rate of startups in the industry with a pioneering spirit; Breaking through foreign technology blockade, independent research and development innovation, with a market share of over 80% for individual products; Persisting in doing the ‘difficult but right thing’, single product revenue has increased 24 times in 8 years… Recently, a reporter from Shanghai Securities News visited Xiamen Tebao Bioengineering Co., Ltd. to record the growth story of this Chinese biopharmaceutical enterprise’s’ breakthrough ‘,’ jointing ‘, and’ heading ‘. Innovative drug research and development ‘nine deaths for a lifetime’ Xiamen Biomedical Port, with the sound of waves, inspires people to strive forward. 30 years ago, this was still a sugarcane field, but now it has become one of the national level industrial clusters ...
Keji Pharmaceutical (02171. HK) has made new progress in its universal CAR-T products. On February 10th, Keji Pharmaceutical announced that the first enrolled patient of the universal BCMA CAR-T developed based on the THANK-u Plus platform had a strict sense of complete response (sCR) and minimal residual disease (MRD) negative efficacy evaluation at the 28th day visit. According to its introduction, the patient is a recurrent/refractory multiple myeloma IgA – λ type (R-ISS stage II), who has received first-line combination therapy and autologous hematopoietic stem cell transplantation in the past. After the last treatment, the disease progressed and was included in the clinical trial. This CAR-T product is intended for the treatment of relapsed/refractory multiple myeloma (R/R MM) or relapsed/refractory plasma cell leukemia (R/R PCL). Affected by this news, on February 10th, the stock price of Keji Pharmaceutical rose by more than 12% at one point after opening, and finally ...
GLP-1 drugs have lived up to expectations and delivered an unexpected result in 2024, with a global market size of 51.8 billion US dollars. The two giant single products, Simeglutide and Tilpotide, continue to soar, with strong growth beyond imagination. Starting from 2022, GLP-1 drugs began to show explosive potential, with a market size exceeding the $20 billion threshold that year, followed by nearly $35 billion in revenue in 2023, and now breaking through $50 billion in one fell swoop, achieving a triple leap in three years and aiming to reach $60 billion by 2025. In terms of market share, both Novo Nordisk and Eli Lilly shine brightly, with the former holding a market share of around 58% and the latter occupying the remaining share. The sales of products developed by other GLP-1 players have declined. From a numerical perspective alone, the GLP-1 market is already comparable to the PD ...
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