Biopharmaceutical Era October 21, 2024 10:04 Zhejiang Disclaimer: Due to limited proficiency, errors are inevitable, or some information may not be timely. Please feel free to leave a message to indicate. This article only provides an introduction to medical and health-related drugs, and does not recommend treatment plans (if applicable); This article does not constitute any investment advice. On October 21, 2024, Xinda Biotechnology announced the Phase II clinical data of its recombinant human vascular endothelial growth factor receptor (VEGFR) – antibody human complement receptor 1 (CR1) fusion protein Efdamrofusp alfa injection (R&D code: IBI302) in neovascular age-related macular degeneration (nAMD) at the 2024 American Academy of Ophthalmology (AAO) Annual Meeting. This presentation attracted the attention of many attending experts and scholars. Phase II clinical study of IBI302 (anti VEGF and anti complement dual target drug) administered at long intervals in subjects with neovascular age-related macular degeneration The data released ...
On October 12, according to the official website of CDE, Johnson & Johnson’s Class 1 new drug JNJ-78278343 injection obtained implicit approval for clinical trials and is suitable for the treatment of adult male patients with advanced prostate cancer. According to public information, JNJ-78278343 is a KLK2-CD3 bispecific antibody and T cell redirection product, which is designed to target KLK2 and induce T cell activation by binding to CD3 on T cells. This product has potential immunomodulatory and anti-tumor activity. After administration, it can bind to CD3 on T cells and KLK2 on tumor cells expressing KLK2, thereby redirecting T cells to tumor cells expressing KLK2, resulting in T cell-mediated lysis of KLK2-expressing tumor cells. At present, Johnson & Johnson has conducted a number of studies on JNJ-78278343 for prostate cancer internationally. Among them, the Phase 1 study of JNJ-78278343 monotherapy for advanced prostate cancer is expected to be initially ...
On October 15, Hengrui Medicine issued an announcement announcing that it had received a “confirmation letter” from the FDA, and the resubmitted PD-1 monoclonal antibody carrelizumab injection combined with apatinib mesylate tablets for the first-line treatment of patients with unresectable or metastatic hepatocellular carcinoma The biologics license application (hereinafter referred to as “BLA”) was accepted by the FDA. According to the Prescription Drug User Fee Act (PDUFA), the FDA’s target review date for carrelizumab injection is March 23, 2025. In October 2023, Hengrui Medicine reached a licensing agreement with Elevar Therapeutics, granting the latter exclusive rights to develop and commercialize carrelizumab liver cancer combination therapy worldwide, excluding Greater China and South Korea. In May this year, HLB-LS, the parent company of Elevar Therapeutics, announced that it had received a complete response letter (CRL) from the FDA regarding the new drug application (NDA) for carrelizumab combined with apatinib for the first-line ...
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 ...
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 ...
ARCH Venture Partners, an American biotech investment institution, announced the completion of over $3 billion in ARCH Venture Fund XIII fundraising, aimed at supporting the establishment and development of early-stage biotech companies. The 13th fund was established following the 12th fund of $2.975 billion announced in June 2022. “After 38 years, ARCH’s investment philosophy remains the same: we bet on great science and great teams to build breakthrough companies,” said Robert Nelsen, co-founder and managing director of ARCH. “We believe that artificial intelligence and new data-driven insights into biology will help build a more preventive, curative and equitable healthcare system.” “ARCH has a long history of identifying the top forward-looking trends in life science R&D and individuals who drive truly groundbreaking scientific hypotheses,” said Keith Crandell, co-founder and managing director of ARCH. “We are very excited about the pace of innovation and efforts to understand diseases at a deeper level.” ...
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 ...
As one of the hottest terms in 2024, “new quality productivity” is not only an upgrade of economic terms, but also a reflection of the process of era change, hiding the pulse of future industrial development. In many reports and documents issued by the state this year, the field of life sciences is closely linked to new quality productivity. At present, Beijing, Shanghai, Guangdong, Chongqing, Zhejiang, Jiangsu and other provinces and cities have successively issued documents to promote the development of new quality productivity and detailed implementation. At present, the field of life sciences is in a period of rapid change, showing unprecedented vitality. After returning to China after studying abroad, many outstanding scholars have greatly promoted the development of this field, especially the development of basic medical research, biotechnology innovation, biopharmaceuticals, clinical diagnosis and treatment. The development is particularly prosperous. Although the medical industry is treacherous, the rules are ...
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