At the high-profile European Lung Cancer Conference (ELCC) 2024, Akesobio and its partner Summit Therapeutics (Summit) jointly released the PD-1/VEGF dual antibody Ivonescimab(AK112/SMT112) combined with chemotherapy for the first-line treatment of advanced non-cancer lung cancer. Updated data from Cohort 1 (EGFR/ALK wild type) of the Phase II small cell lung cancer (NSCLC) clinical study (AK112-201). Previous research results have been published at the 2023 ASCO Annual Meeting and eClinical Medicine, a subsidiary of the top international medical journal “The Lancet”. Cohort 1 included a total of 135 patients with EGFR/ALK wild-type NSCLC who received Ivonescimab combined with chemotherapy, including 63 patients with squamous cell carcinoma and 72 patients with non-squamous cell carcinoma. As of October 2023, the median follow-up time has been further extended to 21.3 months. As the follow-up time is extended, the clinical advantages of Ivosib in the first-line treatment of advanced or metastatic NSCLC become more obvious. ...
Mabwell announced a supply and commercialization agreement with an Indian pharmaceutical company for 9MW0813 (aflibercept intraocular injection, Eylea® biosimilar). According to the agreement, the cooperative company has obtained the exclusive rights to import, produce, register, market and sell 9MW0813 in India, and has the right to obtain non-exclusive rights in 10 countries, including some countries in South Asia and Africa. 9MW0813 is a biosimilar of Eylea® and has completed phase III enrollment in clinical studies in China. Based on the principles of comparative and incremental development and comprehensive evaluation of drugs, pharmaceutical, non-clinical and clinical comparison results indicate that 9MW0813 is highly similar to the originator product in terms of quality, safety and effectiveness. About 9MW0813 9MW0813 is a recombinant human vascular endothelial growth factor receptor-antibody fusion protein, indicated for diabetic macular edema and neovascular (wet) age-related macular degeneration. 9MW0813 is a biosimilar of aflibercept (Eylea®). It is a fusion ...
PhaSER will provide 8HUM mouse models for the TDI to accelerate a pipeline of novel therapeutic targets PhaSER Biomedical has announced its long-term partnership with the Sanders Tri-Institutional Therapeutic Discovery Institute (TDI) to advance the institute’s pre-clinical drug discovery research. Based in the US, the TDI comprises the Memorial Sloan Kettering Cancer Center, Rockefeller University and Weill Cornell Medicine. The TDI, first formed in 2013, aims to provide academic investigators with access to industrial-scale tools and techniques, to more effectively accelerate drug discovery and bring new cures to patients with the greatest medical need. As part of the ten-year agreement, PhaSER will provide 8HUM mouse models for TDI to use to accelerate and improve drug discovery on a pipeline of novel targets in a variety of therapeutic areas. PhaSER’s 8HUM unique mouse models aim to transform the ways drugs are metabolised in humans and use multiple applications in drug discovery ...
It’s reported according to businesswire, AriBio recently announced that it has signed a licensing agreement for the exclusive marketing rights of AR1001, an investigational drug for the treatment of early Alzheimer’s disease, in China at a price of up to US$770 million. Considering the market competition and sales strategy of Alzheimer’s disease drugs in China, the licensee requested that no disclosure be made until the agreed time. The agreement includes an upfront non-refundable payment of 120 billion won (approximately US$90 million), with a total transaction value of up to 5.59 billion yuan (approximately US$770 million), including milestone payments and additional royalties. Upfront payments will begin in mid-2024. AR1001 is a phosphodiesterase type 5 (PDE5) inhibitor in development and an investigational oral drug for the treatment of Alzheimer’s disease. Pre-clinical studies have confirmed that AR1001 can inhibit neuronal apoptosis and restore synaptic plasticity, thus having neuroprotective effects. AR1001 also demonstrated a ...
According to the World Health Organization, TB is responsible for over one million annual deaths Researchers from the National Institute for Health and Care Research’s (NIHR) Southampton Biomedical Research Centre have identified a group of biological markers of tuberculosis (TB) found in high levels among infected patients. Published in the Journal of Clinical Investigation Insight for World TB Day (24 March 2024), findings from the study could advance a simple blood test to speed up the diagnosis of the infection. According to the World Health Organization, TB is the world’s deadliest infectious disease, caused by a bacterium known as Mycobacterium tuberculosis, which is responsible for more than one million deaths each year. Estimated to affect ten million people globally every year, the highly contagious and easily transmitted TB spreads through the air when infected people cough, sneeze or spit, often affecting the lungs. Supported by the NIHR and the UK ...
Recently, the innovative biologic drug Efbemalenograstim alfa Injection (Chinese trade name “Ryzneuta”), independently developed by Evive Biotech and for which Chia Tai Tianqing has exclusive commercialization rights in China, received the “COMMISSION IMPLEMENTING DECISION” issued by the European Commission, approved for sale in the EU. The decision is based on a positive review by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). So far, Efbemalenograstim alfa Injection has become the first domestic innovative biological drug that has been approved for marketing in China, the United States and the European Union. It has also become the first innovative drug approved by the European Union by a Chinese pharmaceutical company in 2024. Previously, Chia Tai Tianqing had signed a commercial cooperation agreement with Evive Biotech and obtained all intellectual property rights and exclusive commercialization rights of Yilisu® in China. Efbemalenograstim alfa Injection is currently the only G-CSF ...
On March 15, 2024, BeiGene announced that the U.S. Food and Drug Administration (FDA) has approved tislelizumab (Chinese trade name: BAIZEAN®; English trade name: TEVIMBRA®) as mono-therapy to treat adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy (without PD-1/L1 inhibitors). Tislelizumab is expected to be available in the United States in the second half of 2024. The approval was based on results from the RATIONALE 302 trial, which met its primary endpoint in the intention-to-treat (ITT) population. Tislelizumab demonstrated a statistically significant and clinically meaningful survival benefit compared with chemotherapy. In the ITT population, median overall survival (OS) was 8.6 months (95% CI: 7.5, 10.4) in the tislelizumab group compared with 6.3 months (95% CI: 5.3, 7.0) in the chemotherapy group (p=0.0001; hazard ratio [HR]=0.70 [95% CI: 0.57, 0.85]). The safety profile of tislelizumab is superior to that of chemotherapy. The most common ...
Recently, Hengrui and its subsidiaries SUZHOU SUNCADIA BIOPHARMACEUTICALS and Chengdu Suncadia Medicine received the “Drug Clinical Trial Approval Notice” approved and issued by the National Medical Products Administration to conduction a Ib/Phase II clinical study for HRS-1167 tablet (Merck code: M9466) combined with SHR-A1921 for injection or combined with bevacizumab or combined with abiraterone acetate tablets (I) and prednisone/prednisolone (AA-P) for the treatment of with advanced solid tumors. In October 2023, Hengrui and Merck reached a strategic cooperation. Merck obtained the exclusive rights to develop, produce and commercialize HRS-1167 (M9466) outside mainland China. This is also the first time for Hengrui to reach a strategic cooperation with large multinational companies. Poly(ADP-ribose) polymerase (PARP) is a multifunctional protein post-translational modification enzyme widely found in eukaryotic cells. It plays a role in maintaining gene stability and maintaining telomere length. Studies have found that PARP inhibitors can hinder DNA damage repair by selectively ...
On March 11, 2024, Sinqi Pharmaceutical Co., Ltd. officially announced that its undependetly developed drug, Xingqi Meioupin® 0.01% Atropine Sulfate Eye Drops indicated for the slowing of the myopia progression in children aged 6 to 12 years from -1.00D to -4.00D (astigmatism ≤1.50D, anisometropia ≤1.50D). Currently, there are no similar products approved for myopia-related indications in China. Xingqi Meioupins® adopts the exclusive MYOSTAFORT® innovative technology, the preparation is more stable, the eye drops are more comfortable, and no preservatives are added, bringing safety, effectiveness, convenience, accessibility and reasonable price to the vast number of myopic children and adolescents in China. In China, there is a high incidence of myopia, low age of onset, and a high proportion of high-grade myopia. Myopia prevention and control has become a national policy. In 2021, the National Health Commission announced: In 2020, our domestic overall myopia rate among children and adolescents was 52.7%, including ...
The challenges and opportunities surrounding Africa becoming a clinical trials global force were discussed on day one of CTS Europe. Révérien Uwacu speaking about the five African countries that have a WHO maturity level of three, signifying high capability of overseeing clinical trials. Image credit: Jenna Philpott/GlobalData. Over 18% of the global population lives in Africa, but less than 3% of clinical trials are conducted there. Is there an opportunity for clinical trials to be conducted in Africa? Experts at the ongoing Clinical Trial Supply (CTS) Europe meeting say the answer is yes, but not without its challenges. Leading the session, “Increasing diversity: supply chain considerations for clinical trials in Africa”, Révérien Uwacu, clinical trial supply management consultant for the pharma company UCB, emphasised the importance of diversity in clinical trials, for scientific, moral, and medical reasons. Révérien cited logistical challenges and regulatory complexities in trial supply management, as some ...
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