PharmaFocus Today – Page 3 – media

Warner Pharmaceuticals obtains drug registration certificate for isoproterenol hydrochloride injection

On December 22, Warner Pharmaceuticals(688799) issued an announcement stating that the company recently received the “Drug Registration Certificate” for isoproterenol hydrochloride injection issued by the National Medical Products Administration. This drug is an injectable preparation, available in 1ml:0.2mg and 5ml:1mg formulations. It is classified as a Class 3 chemical drug, and the approval conclusion indicates that it meets the relevant requirements for drug registration. Isoproterenol hydrochloride injection is primarily used to treat cardiogenic or septic shock, complete atrioventricular block, and cardiac arrest. Obtaining the drug registration certificate will further enrich the company’s formulation product portfolio and optimize its product structure. Although it will not have a significant impact on the company’s performance in the short term, future sales may still be affected by various factors such as policy changes, market demand, and competition from similar drugs, and there is a certain degree of uncertainty. In the first three quarters of ...
- Source: drugdu
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- December 23, 2025
NonaBio and Porton Pharma Solutions have entered into a strategic collaboration to jointly promote the industrialization of innovative complex antibody therapies

On December 22, NonaBio, a company specializing in fully human antibody technology, and Porton Pharma Solutions, a CDMO company, officially entered into a deep strategic cooperation agreement. The two parties will focus on the full lifecycle R&D and production of novel antibody-based therapies, including bispecific and multi-antibody formulations. Through the synergy of “innovative technology platforms + industrialization capabilities,” they aim to address pain points in the industry such as difficult process development, high compliance requirements, significant cost challenges, and long translation cycles, accelerating the transition of innovative therapies from the laboratory to clinical practice and the market. In this collaboration, both parties will leverage their complementary strengths to form a joint development and management team, promoting the integrated development and full-process management of NonaBio’s related projects. They will achieve deep collaboration in key areas such as project management and quality systems, focusing on the entire lifecycle of complex antibody projects ...
- Source: drugdu
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- December 23, 2025
The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation to AMT-253, developed by PuZhong Discovery

On December 17, 2025, according to the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), the key product AMT-253 (a MUC18-targeting ADC) developed by PuZhong Discovery has been included in the Breakthrough Therapy Designation list. The intended indication is for previously treated, unresectable locally advanced, recurrent, or metastatic melanoma. AMT-253 is the world’s first and only MUC18-targeting ADC to have entered clinical development, representing a potential first-in-class ADC therapy for melanoma. It is expected to achieve significant breakthroughs in both treatment mechanisms and paradigms for this indication. In the Australian Phase I and China Phase I/II trials of AMT-253, 36 chemotherapy-naïve melanoma patients were treated with AMT-253. As of September 8, 2025, the objective response rate (ORR) was 41.7%, the disease control rate (DCR) was 80.6%, and the median progression-free survival (mPFS) was 8.5 months. Clinical data suggest that AMT-253 demonstrates clinical ...
- Source: drugdu
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- December 23, 2025
Novel Vaccine Strategy Offers Protection Against Deadly Filovirus Infections

A team from the Scripps Research Institute, a top U.S. biomedical research institution, has transformed nanoparticles into viral “display boxes,” developing a novel vaccine strategy to protect against multiple deadly filovirus infections. In their latest study published in Nature Communications, the team reported that this new vaccine displays filovirus surface proteins on engineered self-assembling protein nanoparticles, enabling the immune system to more effectively recognize and respond to the virus. Experiments showed that it can induce a potent antibody response against multiple viruses, offering a new pathway for developing broader and more effective protective strategies. The filovirus family includes several highly pathogenic viruses, such as Ebola virus, Sudan virus, Bundibugyo virus, and Marburg virus. Although two Ebola vaccines have been approved, there is currently no vaccine capable of providing broad protection against the entire filovirus family. A key reason for their lethality is the structural instability of their surface proteins, which ...
- Source: drugdu
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- December 23, 2025
Nxera seeks schizophrenia programme buyer after Boehringer snub

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/
- Source: drugdu
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- December 22, 2025
First innovative traditional Chinese medicine for frequent tension headaches launched.

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 ...
- Source: drugdu
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- December 22, 2025
The battle for rivaroxaban intensifies! Guilin Pharmaceutical enters the fray with its first generic dry suspension

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 ...
- Source: drugdu
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- December 22, 2025
Another biotech company goes bankrupt

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 ...
- Source: drugdu
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- December 22, 2025
Phase III Clinical Trial of Innovative Prostate Cancer Diagnostic Radiopharmaceutical TLX591-CDx Reaches Primary Endpoint in China

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 ...
- Source: drugdu
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- December 22, 2025
First Subject Dosed in Phase I Multiple Ascending Dose (MAD) Study of LAE102 for the Treatment of Obesity

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
- Source: drugdu
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- December 22, 2025

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