PharmaFocus Today – Page 61 – media

Clinical data of Orelabrutinib for the treatment of MS released

On the evening of February 26, Innocare Biologics announced that the Phase II clinical data of Orelabrutinib, a new BTK inhibitor independently developed by the company, for the treatment of relapsing-remitting multiple sclerosis (RRMS) was released at the 10th Annual Forum of the American Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) in 2025, and a live poster presentation will be held on February 27, Eastern Time. The announcement shows that Orelabrutinib has shown extremely high effectiveness in the treatment of patients with relapsing-remitting multiple sclerosis (RRMS). A dose of 80 mg of Orelabrutinib once a day showed the best efficacy and safety, so it will be used as the dose for the Phase III clinical trial of Orelabrutinib for the treatment of progressive multiple sclerosis (PMS). In a double-blind Phase II clinical trial, 158 eligible relapsing-remitting multiple sclerosis subjects were randomly assigned to four treatment groups in a ...
- Source: drugdu
- 244
- February 28, 2025
Mabwell Biotech’s net profit loss in 2024 was 1.067 billion yuan

On the evening of February 26, Mabwell Biotech (688062) released its 2024 performance report, showing that the company achieved operating income of 199 million yuan, a year-on-year increase of 55.5%; attributable to -1.067 billion yuan, compared with -1.053 billion yuan in the same period last year. Mabwell Biotech said that according to the report layout, the company’s operating income increased from the same period last year. The main reason is that the company actively expanded the market, and the sales of the drug Mai Lishu increased significantly compared with the same period last year. At the same time, the drug Mabwell Health was approved for listing in March 2024. The sales revenue of drugs in the same period of this report increased; with the further expansion of commercialization, operating costs and sales expenses increased accordingly; at the same time, with the continuous advancement of new drug research and development, many ...
- Source: drugdu
- 154
- February 28, 2025
Innovative treatments for ALS, updated progress

The “Ice Bucket Challenge” once brought the rare disease of ALS into the public eye, and Cai Lei used his personal experience and unremitting efforts to let more people understand ALS and promote the whole society’s attention to this disease. It is this indomitable spirit that inspires the scientific research team to continue exploring, and recently this rare disease treatment field has finally ushered in good news. Recently, Shize Bio announced that its independently developed universal iPSC-derived subtype neural precursor cell injection product XS-228 injection has been officially approved by the US FDA to conduct registered clinical trials for the treatment of ALS (amyotrophic lateral sclerosis, ALS). This breakthrough not only marks China’s innovative breakthrough in the field of cell therapy, but also brings new hope to ALS patients. one of the “four major incurable diseases in the world”, ALS is one of the “four major incurable diseases in the ...
- Source: drugdu
- 151
- February 28, 2025
Technological innovation has helped Yuekang Pharmaceutical achieve breakthroughs in new drug research and development

Recently, the Center for Drug Evaluation (CDE) of the National Medical Products Administration announced that the clinical trial application (IND) for the mRNA vaccine YKKYY025 injection for the prevention of respiratory syncytial virus (RSV) submitted by Hangzhou Tianlong Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Yuekang Pharmaceutical, has been accepted. Prior to this, this vaccine had obtained clinical trial approval from the US FDA earlier this year. Understanding and meeting unmet clinical needs has always been the core direction and critical path of our research and development work, “said Yu Weishi, Chairman of Yuekang Pharmaceutical Group. It is reported that in addition to RSV vaccine, Yuekang Pharmaceutical has obtained overseas clinical approvals for multiple innovative drugs. On January 21st, the clinical trial application for YKY026 injection, an mRNA vaccine independently developed by Yuekang Pharmaceutical for the prevention of herpes zoster, was officially accepted by CDE. Due to its previous clinical ...
- Source: drugdu
- 155
- February 27, 2025
1st domestic product! One medical device has obtained CE MDR certification

Recently, MicroPort Xintong Medical Technology Co., Ltd. (hereinafter referred to as Xintong Medical) announced that its subsidiary Shanghai Zuoxin Medical Technology Co., Ltd. has developed AnchorMan ® The left atrial appendage occlusion system has successfully obtained the EU CE MDR certification, becoming the first left atrial appendage occlusion system in China to receive this certification. In addition, the AnchorMan used in conjunction with it ® The left atrial appendage guidance system was also approved for market by the European Union during the same period. The first and only product in the country In recent years, with the further growth of the aging population, the incidence rate of atrial fibrillation has increased year by year. Among them, thromboembolism is the most common complication of atrial fibrillation, with the highest incidence and greatest harm of stroke. The stroke rate of atrial fibrillation patients is five times higher than that of the general ...
- Source: drugdu
- 138
- February 27, 2025
Overview of FDA Approval in January 2025

On January 15, 2025, Eli Lilly and Company announced that the FDA has approved Omvoh (mirikizumab mrkz) for the treatment of moderate to severe active Crohn’s disease (CD) in adults. After being approved as the first treatment for moderate to severe active ulcerative colitis (UC) in adults in October 2023, Omvoh has now been approved in the United States for the treatment of two inflammatory bowel diseases (IBD). Mirikizumab mrkz is a humanized IgG4 monoclonal antibody that selectively binds to the p19 subunit of human IL-23 cytokine. By blocking the interaction with IL-23 receptors, mirikizumab inhibits the release of pro-inflammatory cytokines and chemokines. This is the first biologic therapy to provide two-year, three-year efficacy data for Crohn’s disease upon approval. This drug aims to reduce inflammation of the gastrointestinal tract, which is an important aspect of Crohn’s disease pathology. In addition, Eli Lilly has submitted listing applications for Omvoh for ...
- Source: drugdu
- 172
- February 27, 2025
The first RAP active temperature-controlled aviation box in China is launched to keep medicines in the “cold chain”

On February 25, temperature control is crucial in the field of aviation cold chain transportation, especially in the transportation of vaccines and biopharmaceuticals. CIMC, headquartered in Shenzhen, announced on the 25th that it had successfully developed the first RAP active temperature-controlled aviation box in China. It not only fills the gap in similar products in China, but also enables “heaven-earth linkage” full-process tracking to ensure that medicines do not lose the “cold chain”. For a long time, Chinese airlines have mainly relied on aviation boxes leased from abroad, which is costly. In 2020, Qingdao CIMC Special Refrigeration Equipment Co., Ltd. (hereinafter referred to as “CIMC Qingdao Refrigerated Special Box”), a subsidiary of CIMC, developed the first RKN active temperature-controlled aviation container in China, breaking the foreign monopoly in one fell swoop. The RKN air box is powered by a battery and uses a refrigeration unit to control the temperature inside ...
- Source: drugdu
- 128
- February 27, 2025
R&D is more difficult and the production process is more complicated.

On February 25, the Hong Kong stock price of CanSino Biologics (06185.HK, share price of HK$37.35, market value of HK$9.2 billion) once soared by more than 15%. On the news front, the company issued an announcement the day before, saying that the adsorbed acellular pertussis (component) Haemophilus influenzae type b (combined)-ACYW135 group meningococcal (combined) combined vaccine (DTcP-Hib-MCV4) has been approved for drug clinical trials. This is a pentavalent vaccine that prevents multiple diseases at the same time. It has three components: the first Asian quadrivalent meningococcal conjugate vaccine “Manhaixin” that has been approved for marketing, the second is the adsorbed acellular diphtheria (component) pertussis combined vaccine for infants and young children in the phase III clinical stage, and the third is the Hib vaccine (Haemophilus influenzae type b vaccine) in the phase I clinical stage. It is worth noting that this is the first domestic pentavalent vaccine to reach the ...
- Source: drugdu
- 150
- February 27, 2025
Technological innovation helps Yuekang Pharmaceutical achieve breakthroughs in new drug research and development

Recently, the National Drug Administration Drug Evaluation Center (CDE) announced that the clinical trial application (IND) for the mRNA vaccine YKYY025 injection for the prevention of respiratory syncytial virus (RSV) submitted by Hangzhou Tianlong Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Yuekang Pharmaceutical, has been accepted. Prior to this, this vaccine had been approved for clinical trials by the US FDA at the beginning of this year. “Insight into and meeting clinical needs that have not yet been fully responded to have always been the core orientation and key path for our research and development work.” Yu Weishi, chairman of Yuekang Pharmaceutical Group, said. It is reported that in addition to RSV vaccines, Yuekang Pharmaceutical has obtained overseas clinical approval for a number of innovative drugs. On January 21, Yuekang Pharmaceutical’s independently developed mRNA vaccine YKYY026 injection for the prevention of herpes zoster was officially accepted by CDE. Since it ...
- Source: drugdu
- 217
- February 27, 2025
Pharmaceutical companies connect with DeepSeek to reduce costs, and the cost of accurate error correction of general models is high

DeepSeek is penetrating into various industries. In February 2025, the domestic large model DeepSeek-R1 was fully open source and adapted to multiple fields, and AI medical care also entered a new stage of technology integration and industry reconstruction. Many companies including Aimi Vaccine, Hengrui Medicine, and Zhiyun Health announced that they are combining with AI large models such as DeepSeek. Take the recent announcement of Aimi Vaccine as an example. It stated that as a leading vaccine company in China, the group actively responded to the national “AI+” industrial development strategy and fully deployed access to the DeepSeek large model. However, the financial report of Aimi Vaccine shows that it has faced continuous losses in recent years. To what extent can DeepSeek reduce costs and increase efficiency? Many industry analysts consulted by Blue Whale Finance all said that overall, they are optimistic about the application of AI big models such ...
- Source: drugdu
- 240
- February 27, 2025

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