Search Results for “antibody” – Page 13 – media

The “No.1 Chinese hepatitis C drug” is looking for a new engine

Recently, Ascletis announced that its independently developed small molecule GLP-1R agonist ASC30 is undergoing two Phase I clinical trials in the United States for the treatment of obesity with monthly subcutaneous injections and daily oral tablets. With the launch of these two Phase I clinical trials, Ascletis has officially entered the field of weight loss drugs. This is another highlight of the pipeline after Ascletis announced in April this year that it would focus on the development of core non-alcoholic steatohepatitis (NASH) drugs. Urgent need for a new engine Like most biotechs, Ascletis has also been moving forward by trial and error. However, Ascletis is luckier than most biotechs. It has become famous for its first local original hepatitis C drug Ganovo, which not only broke the monopoly of multinational companies such as Gilead, AbbVie, Bristol-Myers Squibb, and Merck in the domestic hepatitis C drug market, ...
- Source: https://news.yaozh.com/archive/44305.html
- 74
- October 1, 2024
The second half of the battle to defend the Medicine King

Recently, Astellas announced that Japan’s MHLW has approved its ADC drug ennozumab PADCEV and Merck’s K drug as a first-line combination therapy for adult patients with fundamentally unresectable urothelial cancer. With excellent data, this combination treatment regimen was approved by the Japanese MHLW in such a short time after Merck announced on September 4 that it had been approved by the European Commission (EC) as a first-line therapy. However, sporadic victories cannot conceal the plight of K-drugs. For the pharmaceutical industry, the biggest hot spot in the past two weeks is definitely the announcement by Kangfang Biologics on September 8 that ivocilimab has become the world’s first and only single-drug head-to-head phase III clinical study to prove that its efficacy is significantly better than that of pabrolib. The drug Zizumab. On the day the results were announced, Merck’s stock price fell in response, and the dilemma was obvious. Under the ...
- Source: drugdu
- 85
- September 30, 2024
From the rise of Sinocell, we can see the first principles of pharmaceutical companies

In the 1950s, George W. Merck, then CEO of Merck, said a widely circulated saying in the pharmaceutical industry: “We should always remember that drugs are produced for humans, not for the pursuit of profits. As long as we stick to this belief, profits will follow.” It is true. Looking at large overseas pharmaceutical companies, the key to their success lies in patient-centeredness and a strong sense of social responsibility. In China, there are more and more such examples. For example, the vision of Sinocell is to focus on the research and development of drugs urgently needed by the people and provide patients with high-quality and affordable biological drugs. It seems to coincide with Merck. On the product side, Sinocell uses technological innovation to provide higher quality and lower cost drugs, which reduces the economic burden of domestic patients, while bringing better treatment effects and achieving a win-win situation of ...
- Source: drugdu
- 77
- September 30, 2024
Johnson&Johnson’s application for marketing of bevacizumab injection (subcutaneous injection) has been accepted

Public information shows that this is a subcutaneous administration fixed combination of the EGFR/MET bispecific antibody amivantamab developed by Johnson&Johnson and recombinant human hyaluronidase. In June of this year, Johnson&Johnson submitted a biopharmaceutical approval application for subcutaneous injection of bevacizumab to the US FDA, for all indications of approved or submitted intravenous bevacizumab preparations, covering different types of non-small cell lung cancer (NSCLC). According to Johnson&Johnson’s previous press release, patients were able to complete the injection of the subcutaneous formulation within 5 minutes. Evantomab is a humanized EGFR/MET bispecific antibody. It has multiple anti-cancer mechanisms, not only blocking EGFR and MET mediated signaling, but also guiding immune cells to target tumors carrying activating and drug-resistant EGFR/MET mutations and amplifications. The intravenous formulation of this product was first granted accelerated approval by the FDA in May 2021, and has since been approved for multiple indications, including:  Adult patients with locally ...
- Source: drugdu
- 72
- September 28, 2024
Shiyao Group’s $1.195 billion overseas expansion, Claudin 18.2 ADC awarded FDA fast track certification

Insight Database On September 23rd, Elevation Oncology announced that the FDA has granted fast track designation to EO-3021 (SYSA1801) for the treatment of advanced or metastatic gastric and gastroesophageal junction (GC/GEJ) cancer patients expressing Claudin 18.2. The drug was developed by Shiyao Group and authorized overseas equity to Elevation for a total of $1.195 billion in 2022. Image source: Enterprise official website EO-3021 is a potentially most differentiated clinical stage ADC drug of its kind, consisting of an IgG1 monoclonal antibody targeting Claudin 18.2 connected to MMAE via a cleavable linker, with a DAR value of 2. In preclinical studies, the product showed specific growth inhibitory activity on Claudin 18.2 expressing cells in vitro, and had a strong anti-tumor effect on mice implanted with gastric cancer, pancreatic cancer or lung cancer models in vivo. The product has also been proven to be safe for rodents and non-human primates. On July ...
- Source: drugdu
- 94
- September 25, 2024
EGFR mutated NSCLC has an ORR of 80%! Zhikang Hongyi CDH3 ADC announces latest clinical results

Insight Database On September 14th, Zhikang Hongyi announced the latest clinical data (NCT05957471) on the safety and efficacy of its globally exclusive antibody conjugated drug BC3195 (CDH3 ADC) in phase I clinical trials for advanced solid tumors at the 2024 ESMO Annual Meeting. The ORR for patients carrying EGFR mutations reaches 80%.Image source: ESMO official website BC3195 uses antibodies with high affinity for CDH3 protein and exhibits good endocytic activity, as well as clinically validated linkers and effective payload vc MMA with bystander effect. The data released this time shows that BC3195 has controllable security and good PK characteristics. BC3195 has shown significant anti-tumor activity in NSCLC patients, with an overall response rate (ORR) of 36.4%, especially for patients carrying EGFR mutations with an ORR of 80%. The data deadline is August 10, 2024. This phase I clinical study enrolled a total of 34 patients, all of whom were late stage ...
- Source: drugdu
- 74
- September 25, 2024
Junshi Biosciences’ PD-1 Approved in the EU, Achieving Market Launch in China, the US, and Europe

As a result, Toripalimab has become the first and only PD-1 approved for the treatment of nasopharyngeal carcinoma in Europe, as well as the only first-line treatment drug for advanced or metastatic esophageal squamous cell carcinoma regardless of PD-L1 expression. Prior to this, Toripalimab had already been approved in China and the US. On July 28, Junshi Biosciences announced that Toripalimab’s marketing authorization application received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), recommending its approval for the aforementioned indications. Toripalimab injection (Chinese trade name: Tuoyi®) is the first domestically approved PD-1 monoclonal antibody in China. In December 2018, the National Medical Products Administration conditionally approved Toripalimab for the treatment of unresectable or metastatic melanoma in patients who had failed prior systemic therapy. As of now, Toripalimab has received approval for seven indications in China, covering the treatment of melanoma, nasopharyngeal carcinoma, ...
- Source: drugdu
- 100
- September 25, 2024
CHMP recommends H drug for EU market launch

Henlius Biopharmaceutical Editor September 23, 2024 09:21 Shanghai H drug Hans form ® It is the world’s first anti-PD-1 monoclonal antibody approved for first-line treatment of ES-SCLC H drug Hans form ® Expected to become the first and only anti-PD-1 monoclonal antibody marketed in Europe for first-line treatment of ES-SCLC H drug Hans form ® Currently approved for market in countries such as China, Indonesia, Cambodia, and Thailand, benefiting approximately 80000 patients On September 20, 2024, Fosun Pharma (2696. HK) announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the company’s independently developed anti-PD-1 monoclonal antibody H drug, Hansid ® (Sullimumab) has received positive approval for marketing authorization, and it is recommended to approve its indication for first-line treatment of extensive stage small cell lung cancer (ES-SCLC). In 2023, Fosun Pharma partnered with Intas to grant exclusive development and commercialization rights for ...
- Source: drugdu
- 76
- September 24, 2024
Lilly expanded its autoimmune disease product layout

As one of the blue oceans in the field of autoimmune diseases , inflammatory bowel disease (IBD) treatment drugs are sought after and deployed by many multinational pharmaceutical companies. Recently, Eli Lilly acquired Morphic for US$3.2 billion and obtained its core pipeline α4β7 integrin inhibitor MORF-057, further expanding its influence in the field of gastrointestinal diseases. In addition to Eli Lilly, pharmaceutical giants including AbbVie, AstraZeneca, and Merck have laid out IBD treatment drugs and carried out related mergers and acquisitions. Behind the frequent actions, why do multinational pharmaceutical companies favor IBD treatment drugs so much? The dilemma of traditional treatment IBD is a chronic inflammatory bowel disease that mainly affects the digestive system. Its symptoms include severe diarrhea, frequent abdominal pain, blood in the stool, weight loss, and severe cancer. IBD mainly includes two types: ulcerative colitis (UC) and Crohn’s disease (CD). The two IBDs have both overlaps and ...
- Source: drugdu
- 80
- September 24, 2024
Yuheng Biotechnology announces the release of APHEXDA (Antifotide) ®, Motixafortide has been approved for marketing by the Macau Drug Administration in China

Motefutide Macau officially approvedOn September 20, 2024, Guangzhou Yuheng Biotechnology Co., Ltd. (referred to as “Yuheng Biotechnology”) announced the world’s first peptide drug, Mortifutide (APHEXDA), targeting the chemokine receptor 4 (CXC chemokine receptor 4, CXCR4) ®， Motixafortide has recently been officially approved for marketing by the Drug Administration of the Macao Special Administrative Region of China. According to the WHO ATC (Anatomical Therapeutic Chemical Classification System) drug classification management system, it has been approved as immune enhancer L03AX23, which is used in combination with granulocyte colony-stimulating factor (G-CSF) to mobilize hematopoietic stem cells for peripheral blood stem cell collection and subsequent autologous transplantation in patients with multiple myeloma (MM). After Boao, Hainan, Macau has become the second region within Yuheng Biotech’s Asia authorized area to receive approval for Motefutide. Motefutide has obtained new drug approval in the United States in September 2023. It is the first approved innovative drug for ...
- Source: drugdu
- 164
- September 23, 2024

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