Original Time Biopharmaceutical Editor October 14, 2024 09:20 Shanghai The weight loss drug concept stock Zealand has suffered another setback, as its new drug Dasiglucagon, which was launched to treat congenital hyperinsulinemia (CHI) in children, has once again been rejected by the FDA. Last December, Dasiglucagon was rejected by the FDA for the first time due to the discovery of defects in a third-party contract manufacturing factory. Zealand pointed out that the main reason for Dasiglucagon’s second rejection was that the FDA failed to complete the re inspection of third-party production factories, resulting in the approval process being put on hold. The FDA did not raise any concerns about the effectiveness or safety of Dasiglucagon. Dasiglucagon is a glucagon receptor (GCGR) agonist that acts to release stored glycogen from the liver into the bloodstream. Hypoglycemia is one of the most common acute complications of diabetes, and patients who have the ...
The 2024 Nobel Prize in Physiology or Medicine has finally been announced, and surprisingly, the previously highly requested GLP-1 target and alphafold system have not been awarded, and the award-winning fields are similar to last year, which are pioneers in the field of RNA. Last year it was mRNA, this year it is microRNA. On October 7 at 5:30 p.m., the Sweden Carolinska Institutet announced that the 2024 Nobel Prize in Physiology or Medicine was awarded to Victor Ambros and Gary Ruvkun · · for their “discovery of microRNAs and their role in post-transcriptional gene regulation.” It is reported that the two are professors at the University of Massachusetts Medical School and Harvard Medical School, respectively. As we all know, the winner of the Nobel Prize needs to go through a long time from making relevant achievements to winning the Nobel Prize: the Nobel Prize needs time to test its ...
Source: 21st Century Business Herald Has the cow arrived? The A-share market is booming, don’t miss the opportunity, open an account and layout now>> Recently, there has been a frequent wave of business development (BD) cooperation transactions between Chinese and foreign pharmaceutical companies. On October 9th, Baiaotai announced that it has reached an authorization license, production, supply, and commercialization agreement with Gedeon Richter Plc. for BAT2206 (ustekinumab) injection solution. According to the agreement, Baiaotai will license the exclusive commercial rights of the injection in the EU, UK, Switzerland, Australia, and other European markets to Gedeon Richter Plc for a fee. The amount involved in this transaction includes a down payment of $8.5 million, milestone payments up to a cumulative total of $101.5 million, and revenue sharing based on a double-digit percentage of net sales. In addition to Baiaotai, several Chinese pharmaceutical companies have also recently received positive news regarding BD ...
On October 9th, Johnson&Johnson announced plans to invest over $2 billion (approximately RMB 14.1 billion) in Wilson, North Carolina to build an advanced biopharmaceutical manufacturing facility to support its growing portfolio of biologic therapy products in oncology, immunology, and neuroscience. It is reported that this measure is in line with Johnson&Johnson’s broader strategy of submitting or launching over 70 new therapies and product expansions by the end of the next decade. The new facility will be equipped with cutting-edge technology, which will not only enhance global production capacity, but also provide approximately 420 high skilled full-time positions for the local area. The project will begin construction in the first half of 2025. In August of this year, in order to strengthen its position in the cardiovascular field, Johnson&Johnson announced the acquisition of V-Wave, a company specializing in heart failure treatment technology. Prior to this, Johnson&Johnson acquired for approximately $13.1 billion ...
Asthma/COPD is a common respiratory disease in my country, with more than 53 million asthma patients. The prevalence rate in adults is 4.2%, and the prevalence rate in children is 3.07%, with about 7.6 million children. According to statistics, about 30% of urban children with asthma are not diagnosed in time, and more than 20% of children with asthma are not well controlled. There is a huge unmet clinical demand. According to the guideline data, the prevalence of COPD in adults aged 20 and above in my country is 8.6%, and that in adults aged 40 and above is as high as 13.7%. It is estimated that the number of COPD patients in my country is nearly 100 million. According to the full-terminal data of the hospital market of Yaorongyun, although the asthma/COPD drug market has fluctuated due to external factors such as the epidemic and centralized procurement, it has ...
October 11, 2024 09:03 Source: 21st Century Business Herald Has the cow arrived? The A-share market is booming, don’t miss the opportunity, open an account and layout now>> Recently, there has been a frequent wave of business development (BD) cooperation transactions between Chinese and foreign pharmaceutical companies. On October 9th, Baiaotai announced that it has reached an authorization license, production, supply, and commercialization agreement with Gedeon Richter Plc. for BAT2206 (ustekinumab) injection solution. According to the agreement, Baiaotai will license the exclusive commercial rights of the injection in the EU, UK, Switzerland, Australia, and other European markets to Gedeon Richter Plc for a fee. The amount involved in this transaction includes a down payment of $8.5 million, milestone payments up to a cumulative total of $101.5 million, and revenue sharing based on a double-digit percentage of net sales. In addition to Baiaotai, several Chinese pharmaceutical companies have also recently received ...
On October 7, 2024, Shiyao Group and AstraZeneca reached a heavyweight cooperation agreement, which caused quite a stir in the pharmaceutical industry. So, let’s explore together in what aspects the cooperation between Shiyao Group and AstraZeneca can spark. Lung cancer product Axitinib In the field of lung cancer treatment, Shiyao Group has achieved outstanding results in the treatment of non-small cell lung cancer with EGFR exon 20 insertion mutations (EGFR ex20ins) by combining humanized EGFR monoclonal antibodies with AstraZeneca’s heavyweight product, Axitinib. The relevant research data was published in Nature Communication and has been widely recognized by the international academic community. At present, the key phase II single arm study for this indication is also being carried out smoothly, and good clinical research data has been obtained. It will be applied for market as soon as possible. Based on this good cooperation result, representatives from both parties signed a cooperation ...
Lung cancer product Axitinib In the field of lung cancer treatment, CSPC has achieved outstanding results in the treatment of non-small cell lung cancer with EGFR exon 20 insertion mutations (EGFR ex20ins) by combining humanized EGFR monoclonal antibodies with AstraZeneca’s heavyweight product, Axitinib. The relevant research data was published in Nature Communication and has been widely recognized by the international academic community. At present, the key phase II single arm study for this indication is also being carried out smoothly, and good clinical research data has been obtained. It will be applied for market as soon as possible. Based on this good cooperation result, representatives from both parties signed a cooperation agreement in order to continue the collaboration in the Phase III confirmatory study of this indication. Chen Kangwei, General Manager of AstraZeneca China Oncology Division, stated that the strategic cooperation between the two parties is through a strong alliance ...
On October 7, AstraZeneca and CSPC Pharmaceutical Group signed an exclusive licensing agreement, and AstraZeneca will obtain CSPC Pharmaceutical Group’s preclinical candidate small molecule drug YS2302018. The transaction amount hit a new high. According to the agreement, CSPC Pharmaceutical Group will receive an advance payment of US$100 million and is entitled to receive potential development milestone payments of up to US$370 million and potential sales milestone payments of up to US$1.55 billion, as well as tiered sales commissions calculated based on the annual net sales of the product (the total transaction amount exceeds RMB 10 billion at the current exchange rate). YS2302018 is a preclinical innovative small molecule lipoprotein (a) (Lp(a)) inhibitor used to develop new lipid-lowering therapies, as well as monotherapy or combination therapy for a variety of cardiovascular diseases, including in combination with the oral small molecule PCSK9 inhibitor AZD0780. Lpa is an important target in the field ...
Recently, well-known industry media Endpoint News released the “Biopharma’s Most Exciting Startups in 2024” list, which includes 11 biotechnology companies. These emerging research fields include gene editing, immunotherapy, antibody conjugated drugs (ADCs), weight loss therapy, and multiple other directions. This article will introduce these 11 rising stars (listed in no particular order) to readers, based on this ranking and official information from various companies. Lifordi Immunotherapies is a biotechnology company dedicated to developing ADC therapies for the treatment of autoimmune and inflammatory diseases. Lifordi was founded in 2023 and has secured $70 million in Series A funding from ARCH Venture Partners, 5AM Ventures, and Atlas Venture, with the goal of advancing the main candidate drug LFD-200 into clinical trials and obtaining preliminary data by the end of 2025. Lifordi’s main ADC therapy LFD-200 targets myeloid cells and lymphocytes by targeting highly internalized cell surface facial mask proteins. This therapy has ...
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