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 ...
On September 29, Shi Pharma Group signed an exclusive licensing agreement with Jiangsu Conri Pharma on the development and commercialization of JSKN003 in mainland China. JSKN003 is a HER2-targeting bispecific antibody-drug conjugate (ADC) with dual HER2 targeting, giving it stronger internalization induction and bystander killing effects, making it highly active against HER2-expressing tumors. Currently, JSKN003 is undergoing Phase I clinical trials in Australia and Phase I/II and Phase III clinical trials in China. Next, Jinmant Bio (a wholly-owned subsidiary of Chiatai Tianqing Pharmaceutical Group) will be granted exclusive license and sublicensing rights for the development, sales, promised sales, and commercialization of the product. They will bear all clinical development costs and become the sole marketing authorization holder for JSKN003 in Mainland China for that field. According to the agreement, Corning Jerry has the right to receive a total of up to 3.08 billion RMB in upfront and milestone payments, including ...
Cancer is one of the major public health problems facing China and the world. With the aging of China’s population and changes in lifestyle, the incidence of malignant tumors continues to increase. According to the latest data from the National Cancer Center based on tumor registration and follow-up monitoring, there will be 4.8247 million new cases of malignant tumors in China in 2022, and the total number of deaths will reach 2.5742 million1. Malignant tumors are one of the major diseases that threaten the health of Chinese residents. The lifetime risk of cancer among Chinese people is 28.9%2. China has been on the road to fighting cancer. The “Healthy China 2030” Planning Outline clearly states that by 2030, chronic disease health management will be achieved for the entire population and throughout the life cycle, and the overall 5-year cancer survival rate will increase by 15%3; the Cancer Prevention and ...
Drugdu.com expert’s response: FIC (First-in-class) drugs, as their name implies, are the first medications of their kind with entirely novel and unique mechanisms of action, pioneering the treatment of specific diseases. Their latest advancements can be outlined from several perspectives: Ⅰ. Overview of FIC Drugs Globally and in China Global Scope: According to publicly available information, the FDA approved a total of 55 new drugs in 2023, among which 20 were FIC drugs, accounting for 36% of the total. This underscores the pivotal role of FIC drugs in the global drug discovery and development landscape. Chinese Scope: Chinese enterprises are increasingly focusing on innovative drugs. In 2023, 30 of the newly approved drugs in China were developed domestically, constituting 37% of the overall approvals. Furthermore, Chinese scholars’ publications in authoritative journals indicate a significant increase in the total number of innovative products in China’s pipeline, with FIC products growing from ...
Recently, according to publicly available information from the Center for Drug Evaluation (CDE) of the National Medical Products Administration, the technetium-99m ([99mTc]) hydrazinonicotinamide polyethylene glycol RGD peptide injection (referred to as “99mTc-3PRGD2”) developed by Ruidiao Pharmaceuticals has been included in the priority review list. This also applies to the injection of toluenesulfonate hydrazone nicotinamide polyethylene glycol RGD peptide. 99mTc-3PRGD2 is a radiolabeled drug conjugate (RDC) independently developed by Ruidiao Pharmaceuticals. It is the first class I new drug for radiologic diagnosis in nuclear medicine in China and the world’s first broad-spectrum tumor imaging agent for SPECT imaging. Notably, the success of this drug’s development will change the current technical status and conventional understanding that SPECT/CT imaging technology in nuclear medicine cannot be used for tumor diagnosis, staging, and efficacy evaluation. According to Ruidiao Pharmaceuticals, 99mTc-3PRGD2 targets integrin and specifically binds to the integrin αvβ3 receptor on tumor neovascularization, demonstrating high ...
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 ...
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 ...
On September 25, according to foreign media Endpoints, Johnson & Johnson is closing the cardiovascular and metabolic drug unit of its pharmaceutical division. This is the second large-scale reorganization since Johnson & Johnson closed its infectious disease and vaccine units. Johnson & Johnson has gradually downplayed cardiopulmonary and metabolic work since last year. Under the change, Johnson & Johnson has narrowed its research and development focus to three therapeutic areas: oncology, immunology and neuroscience. This reorganization mainly affects the commercialization work of the cardiovascular department (sales, marketing and medical affairs teams), not research and development. At present, the cardiovascular department of Johnson & Johnson’s medical device department has not been affected, and its acquisitions are still ongoing. The core product of Johnson & Johnson’s cardiovascular and metabolic drug department is Xarelto (rivaroxaban), which was once one of the world’s best-selling anticoagulants and was jointly developed by Johnson & Johnson and ...
Juventas Biotech On September 26, 2024, the website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration announced that Heyuan Biotechnology (Tianjin) Co., Ltd. (referred to as “Heyuan Biotechnology”) had launched its first CAR-T cell therapy product, Yuanruida ® The application for marketing authorization for the new indication of (Nakiolenza Injection) has been officially accepted, with acceptance number CXSS2400104, for the treatment of relapsed or refractory large B-cell lymphoma (r/r LBCL) after second-line or above systemic therapy. This is after the recurrence or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) in adults ® The second indication for submitting a new drug listing application domestically. This new drug listing application is based on a single arm, open label, multicenter critical clinical study (NCT04586478) jointly led by the Hematology Hospital of the Chinese Academy of Medical Sciences (Institute of Hematology, Chinese Academy of Medical Sciences) and Ruijin Hospital ...
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