Recently, the FDA officially approved Datroway (datopotamab deruxtecan, Dato-DXd), an innovative antibody-drug conjugate developed by AstraZeneca and Daiichi Sankyo, for the treatment of unresectable or metastatic hormone receptor (HR)-positive, HER2-negative adult breast cancer patients who have received endocrine therapy and chemotherapy. The key basis for the approval of Dato-DXd for breast cancer indications was the positive results of its Phase III clinical study TROPION-Breast01. In the TROPION-Breast01 study, Dato-DXd showed efficacy advantages. Compared with the standard therapy selected by the researchers, the drug successfully reduced the risk of disease progression or death in patients by 37%. This data means that in patients treated with Dato-DXd, the rate of disease deterioration has slowed significantly, giving patients more survival time and treatment opportunities. Specifically, progression-free survival (mPFS) was significantly extended from 4.9 months in the control group to 6.9 months in the trial group. In terms of safety assessment, a key concern ...
Drugdu.com expert’s response: Telitacicept, a novel fusion protein drug for the treatment of autoimmune diseases, has demonstrated its therapeutic efficacy in multiple clinical trials, as detailed below: I. Main Therapeutic Indications and Effects Systemic Lupus Erythematosus (SLE) Telitacicept alleviates SLE symptoms by inhibiting the overactivation of B cells. Clinical trial data indicate that over 60% of patients using Telitacicept experienced significant improvement in their condition, specifically evident in the relief of skin, joint, and kidney symptoms. A multicenter, randomized, double-blind, placebo-controlled pivotal clinical study showed that the 48-week response rate in the high-dose Telitacicept group was 79.2%, significantly higher than the 32.0% in the placebo control group. Another nationwide multicenter, randomized, double-blind, placebo-controlled Phase IIb drug study showed that the Telitacicept 160mg dose group (the standard dose approved for marketing in China) had significantly higher response rates than the placebo group from Week 12 onwards, and the efficacy advantage persisted ...
Recently, the 2024 DR equipment public bidding and procurement list was released, and domestic medical equipment won 10 of the 12 lists, marking the transformation of domestic substitution towards innovative applications. Wandong Medical has the highest market share and has dominated the list for more than ten consecutive years, deserving the title of DR King. In fact, the overall situation of DR equipment in 2024 is not optimistic. According to statistics from Zhongcheng Data Science, the overall market size of medical device bidding in China decreased by 21.1% year-on-year in 2024, with the DR equipment market also decreasing by 21.5%. The reasons for the decline are the multiple impacts of medical policies, technological innovations, and competitive trends. From the perspective of procurement trends, the market is divided into two levels: centralized procurement and high-level hospitals, which means higher requirements are placed on domestic medical equipment. It is worth mentioning that ...
On January 16, 2025, Huapu Biotechnology completed the company’s change registration, the board of directors was adjusted, and Liu Yongjun was appointed as the chairman. This is also the first time that Liu Yongjun has clearly announced his new destination since leaving Shiyao Group in December last year. Huapu Biotechnology was founded in 2001 and is located in Shijiazhuang, Hebei Province. Based on immunology, it focuses on the development of new drugs in the fields of tumors, infections, and autoimmune diseases. At present, a CpG technology platform has been established for the development of innovative vaccines, tumor immunotherapy, etc. Liu Yongjun was established as a scientific founder at the beginning of the company, and another scientific founder was Professor Chen Jianzhu. Wang Xinzhong, the founder of Fushengkang, served as the global R&D president and chief scientist of the company after the merger was completed. The three R&D experts are all ...
On January 22, the National Health Commission and the State Administration of Traditional Chinese Medicine jointly issued the “Influenza Diagnosis and Treatment Plan (2025 Edition)” (hereinafter referred to as the “New Edition”). Compared with the “Influenza Diagnosis and Treatment Plan (2020 Edition)” (hereinafter referred to as the “2020 Edition”), the new version includes two anti-influenza virus drugs, Mabaloxavir and Favipiravir. Amantadine and rimantadine were eliminated due to drug resistance issues. At the same time, the new version of the plan clearly stated that it is not recommended to use antiviral drugs with the same mechanism of action in combination. Many pharmacists pointed out to the 21st Century Business Herald reporter that this move is aimed at optimizing the treatment effect and reducing unnecessary side effects. After the replacement of drugs, more and more companies have seen the development potential of the anti-influenza drug market. Competition in the oseltamivir market has ...
On the evening of January 22, Kangtai Biological released its 2024 performance forecast. The performance forecast shows that in 2024, Kangtai Biological will achieve a net profit of 190 million to 270 million yuan, a year-on-year decrease of 77.94% to 68.65%. Last year, this figure was 861 million yuan. Kangtai Biological said that due to market competition, inventory reduction and other factors, the company’s operating income has declined to a certain extent compared with the same period last year; coupled with the increase in fixed asset depreciation expenses, asset impairment, and the termination of the 2023 equity incentive plan to accelerate the exercise of rights, the net profit in 2024 has decreased compared with the same period last year. On January 23, Jiemian News called Kangtai Biological’s secretary’s office. The staff responded that Kangtai Biological’s full range of products has not been reduced in price. Since the unit price of ...
On January 21, the Phase I clinical research launch meeting of the MVA strain monkeypox live attenuated vaccine independently developed by Sinopharm Group China National Biotec Group Shanghai Institute of Biological Products was held at the Henan Provincial Infectious Disease Hospital (Zhengzhou Sixth People’s Hospital). The launch meeting was fully trained and discussed around the clinical trial plan, key points and difficulties of clinical site operations. On September 9, 2024, this monkeypox vaccine obtained the clinical trial notification issued by the State Food and Drug Administration. It is the first monkeypox vaccine approved for clinical trials in my country and is expected to play an important role in the prevention and control of diseases caused by monkeypox virus in my country. On January 22, the first batch of subjects in the Phase I clinical trial of the MVA strain monkeypox live attenuated vaccine were enrolled, marking that my country’s first ...
On January 21, Baili Tianheng released its 2024 performance forecast, expecting to achieve annual operating income of approximately 5.8 billion yuan, a year-on-year increase of 932.27%; the net profit attributable to the parent company’s owners is expected to be 3.6 billion yuan, an increase of 4.38 billion yuan from the same period last year, and will turn losses into profits. The notice disclosed that this significant performance growth was mainly due to the irrevocable, non-deductible down payment of US$800 million paid by the company’s overseas partner Bristol-Myers Squibb (BMS) for its core product BL-B01D1 during the reporting period, which led to a significant increase in the company’s operating income. BL-B01D1 is a dual-antibody ADC targeting EGFR×HER3. It is the world’s first and only drug of its kind to enter the clinical stage. At the end of 2023, SystImmune, a wholly-owned subsidiary of Baili Tianheng, reached an exclusive licensing and cooperation ...
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 ...
At present, my country’s medical security has entered a new stage of high-quality development with rapid expansion, deepening reform and continuous innovation. It has carried out 10 batches of national organized drug centralized procurement and 5 batches of national organized high-value medical consumables centralized procurement, including a total of 435 kinds of drugs, and commonly used high-value medical consumables cover cardiology, orthopedics, etc. At the beginning of 2025, my country’s medicine centralized procurement ushered in a new opportunity to “go out”. Recently, the China-ASEAN Regional Medicine Centralized Procurement Platform was officially launched in Fangchenggang City, Guangxi. It is the first cross-border medicine regional centralized procurement platform guided by the National Medical Security Administration. Build an open pharmaceutical procurement cooperation platform According to reports, the China-ASEAN Regional Pharmaceutical Procurement Platform is responsible for carrying out joint procurement in some regions of China and ASEAN countries. It will explore innovative regional medical, ...
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