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 ...
March 4), according to the CDE official website, Lundbeck’s clinical trial application for Class 1 chemical drug Lu AF28996 capsules has been accepted. Currently, the drug is undergoing Phase I clinical trials overseas. Parkinson’s disease is a neurological dysfunction disease with complex symptoms and difficult early diagnosis. It is common in middle-aged and elderly people. At present, the main treatment for Parkinson’s disease is drug therapy, with the purpose of reducing symptoms, delaying the progression, and improving the patient’s quality of life. Lu AF28996 is a dopamine D1/D2 receptor agonist developed by Lundbeck Pharmaceuticals. It is a relatively new anti-Parkinson therapy and is currently undergoing Phase I clinical trials overseas. Among them, a study to evaluate the safety, tolerability, etc. of Lu AF28996 in Parkinson’s patients is expected to be completed in 2025. This time, the approval of Lu AF28996’s clinical trial application in China is expected to bring a ...
Davy James Trogarzo (ibalizumab-uiyk) is currently approved in combination with other antiretroviral therapy for heavily treatment-experienced adults with multidrug resistant HIV-1 infection who are failing their current antiretroviral regimen. The FDA has issued a refusal to file letter (RTF) to a supplemental Biologics License Application (sBLA) filed by Theratechnologies Inc. for an intramuscular (IM) method of administration for maintenance dosing of Trogarzo (ibalizumab-uiyk).1 The CD4-directed post-attachment HIV-1 inhibitor is approved in combination with other antiretroviral therapy (ART) for heavily treatment-experienced adults with multidrug resistant HIV-1 infection who are failing their current ART regimen.2 The RTF followed a preliminary review of the sBLA by the FDA, which found that the application did not include data the agency required to establish a pharmacokinetic bridge between IM administration and intravenous (IV) administration of Trogarzo. “While we are disappointed to receive this letter from the FDA, we were aware that the approval of this ...
According to the CDE official website, AstraZeneca’s Class 1 therapeutic biological product AZD0486 has obtained implicit approval for clinical trials and is intended to be used to treat relapsed or refractory B-cell acute lymphoblastic leukemia. AZD0486 (TNB-486) is a new, fully human CD19xCD3 IgG4 bispecific antibody, originally developed by TeneoTwo. In 2022, AstraZeneca acquired TeneoTwo for US$1.265 billion and also obtained its clinical-stage drug TNB-486. According to public information, AZD0486 can bind to CD19 on the surface of B lymphocytes and CD3 receptors on the surface of T lymphocytes, thereby initiating the immune response of T lymphocytes. A Phase I clinical study (NCT04594642) published in the journal “OncLive” in August 2023 showed that AZD0486 has a durable tumor inhibitory effect on relapsed/refractory follicular lymphoma, regardless of the expression level of CD20, and it is also independent of the type and dosage of existing drugs. Currently, AZD0486 has entered the Phase ...
On February 26, the Center of Drug Evaluation of the NMPA issued the “Notice on Setting up a Legal Document Submission Module on the Patent Information Registration Platform for Marketed Drugs in China” (hereinafter referred to as the “Notice”). The following is the original content of the Notice: Since the implementation of the “Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (Trial)”, patent disputes have been resolved simultaneously during the review of generic drug marketing applications. In order to further improve work efficiency and facilitate patent holders, interested parties and generic drug applicants to submit relevant legal documents, a legal document submission module has been set up on the Chinese marketed drug patent information registration platform. From the date of issuance of this notice, patentees, interested parties or generic drug applicants can directly submit an “application for setting a waiting period”, acceptance notice, judgment, decision or settlement ...
According to the Hong Kong Stock Exchange, on February 26, Jiangsu Qyuns Therapeutics-B passed the IPO hearing on the main board of the Hong Kong Stock Exchange and will be listed soon. It is reported that Qyuns Therapeutics was established in 2015. It is a clinical-stage biotechnology company completely focused on biotherapeutics of autoimmune and allergic diseases, covering four major disease areas: skin, rheumatism, respiratory and digestive tract diseases. According to its official website, based on its complete independent innovation capabilities, Qyuns Therapeutics has formed two core products, QX002N and QX005N, as well as a product pipeline of seven other drug candidates. One variety has been accepted by BLA, one is in clinical phase 3, and four varieties are in clinical phase 2 and 1 respectively. The indications cover silver eyebrow disease, atopic dermatitis, ankylosing spondylitis, systemic lupus erythematosus, It covers four major disease areas including asthma, inflammatory bowel disease, ...
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