Japan-based Nxera Pharma is seeking buyers for its Phase II-ready schizophrenia programme after Boehringer Ingelheim decided not to exercise a licensing option. Boehringer Ingelheim, which held exclusive rights to license the neurological disorder portfolio of GPR52 agonists, did not provide further information to Nxera. Rights to the programme will now revert to the Japanese biotech. Nxera said it is now exploring strategic opportunities for the programme, including a licensing partnership with a major pharmaceutical or specialist neuroscience company in 2026. Despite the hitch, Nxera said there will be no financial impact. https://www.pharmaceutical-technology.com/news/nxera-seeks-schizophrenia-programme-buyer-after-boehringer-snub/
On December 21, Fang Sheng Pharmaceutical…A product launch and investor relations event for “Yangxue Qufeng Zhitong Granules” was held in Changsha. A representative from Fang Sheng Pharmaceutical stated that Yangxue Qufeng Zhitong Granules is China’s first Class 1.1 traditional Chinese medicine specifically formulated for frequent tension-type headaches.Innovative drugsIn June 2025, it obtained the Drug Registration Certificate issued by the National Medical Products Administration. This new drug is derived from the classic formula “Shengxian Decoction” by Zhang Xichun, a famous doctor in modern times. After more than ten years of research and development and clinical trials, it has become the first innovative Chinese medicine in China that is clearly targeted at frequent tension headaches (Qi and Blood Deficiency Syndrome) . The new product has a large potential market demand. According to the “Guidelines for the Diagnosis and Treatment of Tension-Type Headache in China” (2023) compiled and released by the Chinese Society ...
From December 8th to December 14th , a total of 65 varieties passed/were deemed to have passed the consistency evaluation. During the same period, 69 varieties applied for consistency evaluation. 01 Guilin Nanfang Pharmaceutical: Rivaroxaban Dry Suspension On December 9th, the official website of the National Medical Products Administration (NMPA) showed that Guilin Nanfang Pharmaceutical’s rivaroxaban dry suspension was officially approved, becoming the first generic and the first product to pass the consistency evaluation in China for this dosage form. Image source: NMPA official website. Rivaroxaban was jointly developed by Bayer and Johnson & Johnson. Since entering China in 2009, it has become one of the oral anticoagulants for the prevention and treatment of venous thrombosis, stroke, and pulmonary embolism. Global sales in 2024 still exceeded RMB 43.8 billion. Intense competition. Currently, 58 companies in China hold approvals for rivaroxaban, expanding into four dosage forms: tablets, granules, dry suspensions, and ...
Recently, biotechnology company Mythic Therapeutics announced the termination of all its operations due to failed financing, and the clinical trial of its only investigational ADC drug, MYTX-011, was also aborted. The founding of Mythic Therapeutics stemmed from a forward-thinking technological narrative. While traditional ADC technology focused on three key innovation dimensions—connector coupling technology and novel targets—its founder, Brian Fiske, aspired to open a fourth dimension : regulating the fate of ADCs within cells . to broaden the therapeutic window of ADCs without relying on novel payloads or linkers by precisely improving the internalization of ADCs in target tissues while reducing non-specific release in healthy tissues . nine top investment institutions, including Viking Global, Venrock Healthcare Capital Partners, Foresite Capital, and Perceptive Advisors, during the 2021 biotech funding boom, raising over $100 million . The company quickly invested resources in a series of new ADC projects based on the platform, with ...
Grand Pharmaceutical’s Innovative Radiopharmaceutical TLX591-CDx for Prostate Cancer Diagnosis Meets Primary Clinical Endpoints in China Phase III Trial Journalist: Zhang Min | December 21, 2025 December 21, 2025 — Grand Pharmaceutical Group Limited (0512.HK), a Hong Kong-listed company, announced that its innovative Radionuclide Drug Conjugate (RDC) for prostate cancer diagnosis, TLX591-CDx (Illuccix®, gallium Ga68 PSMA-11), has achieved positive top-line results and successfully met its primary clinical endpoints in a Phase III trial conducted in China. According to the announcement, TLX591-CDx is a globally innovative diagnostic radiopharmaceutical based on radionuclide-small molecule conjugate technology targeting Prostate-Specific Membrane Antigen (PSMA). It is indicated for the diagnosis of both newly diagnosed and recurrent prostate cancer. The Phase III study was a single-arm, open-label trial involving over 100 patients with biochemical recurrence (BCR) of prostate cancer. The study utilized PET/CT or PET/MRI imaging following TLX591-CDx administration to evaluate the product’s diagnostic efficacy, safety, and tolerability ...
SouthCN, Dec 22 (Report) — Laekna (2105.HK) announced on the HKEX on the morning of December 22 that the Group has launched subject enrollment for its Phase I Multiple Ascending Dose (MAD) study of LAE102 for the treatment of obesity in China, with the first subject already successfully dosed. https://finance.eastmoney.com/a/202512223597697444.html
Shanghai Securities News, China Securities Network (Reporter Zhang Xue) – CanSino announced on December 20 that its Diphtheria, Tetanus, acellular Pertussis (component), Haemophilus influenzae type b (conjugate), and ACYW135 Meningococcal Polysaccharide (conjugate) Combined Vaccine (hereinafter referred to as the “DTcP-Hib-MCV4 Combined Vaccine”) has officially initiated a Phase I clinical trial and has enrolled the first participant. The trial aims to evaluate the safety and immunogenicity of the vaccine in individuals aged 2 months to 6 years. With the increasing variety of vaccines available in China, the use of multiple-dose vaccines has raised challenges such as increased discomfort for children during vaccination, higher costs for healthcare authorities, difficulties and expenses in vaccine management, reduced compliance among young children, and a heightened possibility of suspected adverse reactions. Consequently, the development of combined vaccines that simultaneously prevent multiple diseases has become a key trend in new vaccine R&D. The company stated that initiating ...
“Our laboratory focuses on protein subunit vaccine research, and we have recently achieved a breakthrough. The structure of the COVID-19 RBD subunit vaccine can be extended to an octamer or hexamer, further enhancing its broad-spectrum efficacy,” stated Gao Fu, a pathologist, microbiologist, immunologist, and Academician of the Chinese Academy of Sciences, during the “Good Hope Science Salon” held on December 20. Gao Fu emphasized that the pandemic has accelerated fundamental research and industrialization in immunology and vaccinology, and that a deeper understanding of basic science can shorten the path from research to product development. “Understanding how influenza viruses enter cells via sialic acid receptors helps us develop drugs to block this process,” Gao Fu noted. By studying how viruses activate host immune responses, more effective vaccines can be designed to enhance the immune system’s ability to recognize and eliminate viruses. For a long time, insufficient vaccine efficacy has been one ...
Drugdu.com expert’s response: Respirators and oxygen concentrators exhibit significant differences in functional positioning, working principles, applicable scenarios, and usage methods. Here is a detailed comparative analysis: I. Core Functional Positioning A respirator is a “respiratory support device” whose core function is to replace or assist human breathing. It addresses two types of issues through mechanical ventilation: Insufficient respiratory drive: Such as respiratory failure or neuromuscular diseases (e.g., amyotrophic lateral sclerosis, spinal cord injuries) that render individuals unable to breathe autonomously. Airway obstruction: Such as sleep apnea syndrome (snoring with breathing pauses) or airway spasms during acute asthma attacks. Respirators not only deliver oxygen but also help expel carbon dioxide through positive pressure, maintaining overall gas exchange in the body. An oxygen concentrator is an “oxygen supplementation device” whose core function is to increase the concentration of inhaled oxygen. It extracts oxygen from the air (with oxygen concentrations reaching over 90%) ...
Drugdu.com expert’s response: To swiftly apply for Class II and Class III medical device certificates, it is essential to clarify the classification requirements, prepare complete materials, submit the application according to the process, and actively cooperate with the review. Additionally, leveraging professional agency services can enhance efficiency. Below is a detailed explanation: I. Clarify Classification and Requirements Class II Medical Devices: These pose moderate risks and require either business registration or production licensing. Class III Medical Devices: These carry higher risks and must obtain business licensing or production licensing. II. Prepare Application Materials Class II Medical Device Business Registration Materials Registration Application Form: Requires the signature of the legal representative and the company seal. Corporate Qualification Proof: Includes a copy of the business license, with the business scope including “Class II medical device sales” or similar wording. Personnel Qualification Proof: Identification documents and educational or professional title certificates of the ...
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