PharmaFocus Today – Page 13 – media

A blockbuster drug with a market value of 5 billion yuan has been approved for a new indication

Recently, Shenyang Sansheng Pharmaceutical announced that its core product, recombinant human thrombopoietin injection (Tebio), has been officially approved by the National Medical Products Administration for a new indication: for adult patients with chronic liver disease-related thrombocytopenia (CLDT) who are scheduled to undergo surgery (including diagnostic procedures) . It is worth mentioning that, according to data from PharmNet, TEBIA’s sales in domestic public medical institutions exceeded 5 billion yuan in 2024. This new indication is its fourth approved indication, which will further consolidate its leading position in the thrombocytopenia treatment market. 01 The Road to Glory The story of TBIA began in the early days of China’s biopharmaceutical industry. In 2005, when imported biopharmaceuticals dominated the Chinese market, 3SBio’s independently developed recombinant human thrombopoietin injection was approved for marketing, becoming the world’s only commercially available recombinant human thrombopoietin product and China’s first Class 1 new drug biological product approved in China. ...
- Source: drugdu
- 73
- December 29, 2025
2025 Biopharmaceutical CEO Star

In the biopharmaceutical industry in 2025, the names of several key figures were frequently mentioned. The choices they made during merger and acquisition negotiations, pipeline advancement, commercialization, or company turning points directly influenced the company’s trajectory that year. 01 CEOs who drive up the value of M&A deals In the unpredictable biopharmaceutical M&A landscape of 2025, one of the most memorable cases is the “value maximization” case involving Metsera . The obesity market was already hot due to GLP-1 competition, but Metera wasn’t a giant company. Its value stemmed more from the potential assessment of its early assets and its judgment of the future market landscape. The co-founders, Whit Bernard and Clive Meanwell , seized the opportunities presented by the times. Amidst a dazzling array of offers, they skillfully used their business negotiation techniques, controlling the pace, information disclosure, and bidding mechanisms to ultimately push Pfizer’s seemingly settled $7 billion ...
- Source: drugdu
- 54
- December 29, 2025
Hybio Pharmaceutical and Dr. Reddy’s Forge Strategic Cooperation on Peptide APIs to Advance Global Peptide Layout

Journalists have learned from Hybio Pharmaceutical (300199) that on December 25, a signing ceremony was held in Beijing between Hybio Pharmaceutical and the world-renowned pharmaceutical company Dr. Reddy’s Laboratories. The two parties formally signed a non-binding term sheet for strategic cooperation in the field of peptide Active Pharmaceutical Ingredients (APIs) and related formulations, marking a successful start to their strategic partnership. It is reported that this cooperation resulted from in-depth prior consultations and strategic alignment. In September 2025, the global CEO of Dr. Reddy’s led a team to visit Hybio’s headquarters and production bases. The two sides held deep discussions on key issues such as peptide drug R&D innovation, global commercialization strategies, and potential strategic directions, followed by multiple rounds of face-to-face exchanges during international conferences such as CPHI. According to the cooperation framework, the two parties have reached a preliminary consensus on the scope of cooperation and overall strategy ...
- Source: drugdu
- 58
- December 29, 2025
Phase II Clinical Trial Application for New Lung Cancer Intraoperative Visualization Drug FZ-P001 Sodium for Injection Has Been Accepted

China Securities Intelligent Finance News — On the evening of December 28, Shanghai Fudan-Zhangjiang Bio-Pharmaceutical (01349) announced that it has received an “Acceptance Notice” from the National Medical Products Administration (NMPA). The Phase II clinical trial application for its self-developed Class 1 innovative drug, FZ-P001 Sodium for Injection, has been accepted. The drug is intended for the intraoperative visualization of malignant lesions in patients with known or suspected lung cancer. According to the announcement, the drug is an innovative photosensitizer targeting folate receptor alpha (FRα). It utilizes near-infrared (NIR) fluorescence imaging technology to indicate residual tumor tissue and surgical margins during procedures, aiming to improve the surgical resection outcomes for solid tumors such as lung cancer. Citing relevant data, the announcement noted that in 2022, China saw 1.061 million new lung cancer cases and 733,000 deaths, with lung cancer ranking first in both incidence and mortality among malignant tumors. The ...
- Source: drugdu
- 50
- December 29, 2025
Innovative Drug KarXT® (Karigel®) Approved in China

On December 23, Zai Lab officially announced that the National Medical Products Administration (NMPA) of China has approved the New Drug Application (NDA) for Xanomeline-Trospium Chloride Capsules (Brand name: KarXT®/Kaigele®), indicated for the treatment of adult patients with schizophrenia. The press release noted that this marks the first approved schizophrenia therapy with a novel mechanism of action in more than 70 years. Unlike traditional antipsychotics that target dopamine receptors, KarXT® exerts its effects on core disease pathways by selectively acting on muscarinic acetylcholine M1 and M4 receptors in the brain. Schizophrenia affects over 8 million adults in China, yet fewer than half of them receive formal treatment. The disease severely impairs patients’ abilities to think, feel, and behave, characterized by positive symptoms, negative symptoms, and cognitive impairments. Unfortunately, many patients continue to face inadequate symptom relief or adverse effects during treatment with existing antipsychotic medications. Statistics show that approximately 75% ...
- Source: drugdu
- 104
- December 26, 2025
Xueji Biotech Completes Over RMB 100 Million Initial Close of Series B1 Equity Funding and Over RMB 100 Million in Debt Funding

Recently, Suzhou Xueji Biotechnology Co., Ltd. (hereinafter referred to as “Xueji Biotech”) announced the completion of over RMB 100 million in Series B1 equity financing, and secured over RMB 100 million in credit-based debt financing from multiple banks. The proceeds will be allocated to the company’s core business—the ex vivo regeneration of platelet lineage—to address issues such as blood supply shortage and blood-borne diseases, drastically reduce adverse reactions caused by blood transfusion, as well as develop novel drugs derived from regenerated platelets. The first tranche of this round of Series B1 equity financing, totalling over RMB 100 million, was led by Hainan Grand Health Medical Group, with participation from Yonghui Ventures and other investors. The funds will be mainly used for clinical trials of Xueji Biotech’s first two pipelines and preclinical development of other key pipelines to support the company’s rapid growth. Meanwhile, the second tranche of Series B1 financing ...
- Source: drugdu
- 92
- December 26, 2025
Just 1 minute! Roche’s bispecific antibody subcutaneous injection formulation receives FDA approval for market launch

On February 22, Roche announced that the FDA has approved Lunsumio VELO™ ( motuzumab subcutaneous injection) , a CD20/CD3 bispecific antibody , for the treatment of relapsed or refractory (R/R) follicular lymphoma (FL) in patients who have received at least two lines of systemic therapy . Based on the results of the Phase I/II GO29781 study, motuzumab subcutaneous injection received accelerated approval from the FDA . Full approval may depend on validation and confirmation of efficacy in confirmatory trials. Previously, in November, this indication received conditional approval from the European Union. Source: Roche official website Compared to intravenous infusions that require 2-4 hours, the subcutaneous form of motuzumab can be administered in approximately 1 minute , significantly reducing treatment time. Like the intravenous version , the subcutaneous form can also be administered on an outpatient basis, with a fixed treatment duration, up to six months. The FDA approval was based ...
- Source: drugdu
- 65
- December 26, 2025
Pfizer loses out in hemophilia

For Pfizer, which has suffered a major setback in the field of gene therapy, the year 2025, which is about to end, has indeed been incredibly difficult. Now, the giant faces further troubles in the field of next-generation therapies, which are seen as potential successors. On December 14, a patient who participated in the long-term extended study of Pfizer’s new hemophilia drug Hympavzi died from cerebellar infarction followed by cerebral hemorrhage. This patient, suffering from hemophilia A and on inhibitors, underwent minor surgery and was routinely using the experimental drug Hympavzi for prophylaxis, as well as recombinant coagulation factor VIIa for perioperative hemostasis management. Tragically, the incident occurred a few days later. The exact reasons are still under investigation. Pfizer quickly initiated a review with researchers and an independent data monitoring committee, and notified regulatory agencies. However, the patient’s death is like a boulder thrown into a lake in the ...
- Source: drugdu
- 67
- December 26, 2025
Maiwei Biotech’s new monoclonal antibody drug has received FDA approval to begin Phase 2a clinical trials for COPD

On December 24, Maiwei Bio announced that its independently developed anti-ST2 monoclonal antibody innovative drug (development code: 9MW1911) has officially received approval from the US FDA for clinical trials, which can be used to conduct phase 2a clinical studies for moderate to severe chronic obstructive pulmonary disease (COPD) . 9MW1911 binds to the ST2 receptor with high affinity, thereby blocking the IL33/ST2 signaling pathway. This drug has completed a Phase 2a clinical trial (N=80) in China for patients with moderate to severe COPD, and the results showed: Compared with placebo (N=20), the study was safe and well-tolerated in all dose groups, with an overall adverse event rate similar to that in the placebo group (70% vs 85%). All subjects were immunogenic and no new safety risk signals were identified. Pharmacokinetic results suggest that drug exposure increases with increasing dose, and the exposure-response model can preliminarily establish a dose-response relationship, providing ...
- Source: drugdu
- 79
- December 26, 2025
Gravel Biotech’s next-generation gene knockout TIL product GT307 injection receives FDA IND approval in the United States

On December 23, 2025, GT307 injection , a next-generation gene-knockout tumor-infiltrating lymphocyte (TIL) product independently developed by Sapphire Biotech , received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) . This marks another significant milestone for Sapphire Biotech in the field of high-safety gene-edited TILs, following the completion of clinical trial applications for its GT201 product in China and the United States. It also signifies that multiple cell therapy pipelines of the company have entered the clinical stage in the United States. GT307 is a next-generation dual-gene knockout TIL product based on CRISPR gene editing technology, designed to address key bottlenecks in traditional TILs, such as functional exhaustion and insufficient persistence in the tumor microenvironment. Leveraging the ImmuT Finder® high-throughput immunomodulatory target screening platform independently developed by SandGrey Biotech, the company systematically discovered and identified key immunomodulatory factors that inhibit the anti-tumor function of TILs, ...
- Source: drugdu
- 74
- December 26, 2025

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