NEWS

GSK’s Nucala (Mepolizumab) Secures the NMPA’s Approval for Treating Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

Shots: The NMPA has approved Nucala as an add-on therapy with intranasal corticosteroids in CRSwNP adults with inadequately controlled disease. It is approved for patients (≥12yrs.) as an add-on treatment of severe eosinophilic asthma & for adults having eosinophilic granulomatosis with polyangiitis Approval was based on 2 P-III studies: MERIT assessing Nucala vs PBO…

January 3, 2025

The China’s NMPA Grants Approval to Genesis Medtech’s Articulation Powered Stapler, iReach Omnia, for Complex Surgeries

Shots: The NMPA has approved iReach Omnia for market release, enhancing precision and access in complex laparoscopic surgeries The iReach Omnia transforms surgical stapling with 90° articulation, offering precision and maneuverability in confined spaces. It minimizes staple line weak points, reduces anastomotic leakage risks & enhances outcomes in complex procedures like colorectal and thoracic…

January 3, 2025

Hanx Biopharmaceuticals Reports the First Patient Dosing with HX044 in P-I Clinical Evaluation

Shots: Hanx Biopharmaceuticals has dosed the first patient with HX044 under its P-I clinical evaluation for treating solid tumors The dose escalation & expansion P-I/IIa (HX044-I-01) trial will assess safety, tolerability, PK profile & initial efficacy of HX044 for the treatment of advanced solid tumor malignancies HX044 is a first-in-class bispecific antibody and…

January 3, 2025

Innovent Reports the NMPA’s Approval of Dovbleron (Taletrectinib Adipate Capsule) for Treating ROS1-Positive NSCLC

Shots: The NMPA has approved another NDA of Dovbleron (ROS1 tyrosine kinase inhibitor) for treating locally advanced or metastatic ROS1+ NSCLC. It was approved for those with ROS1+ NSCLC previously treated with ROS1 TKIs in Dec 2024 The approval was supported by pivotal P-II (TRUST-I) study assessing safety, tolerability and efficacy of Dovbleron to…

January 3, 2025

PettureX Reports the Launch of AI Pet Health Scanner App, Addressing Pet Health

Shots: PettureX has reported the launch of its AI-based health scanning app, PettureX App, available through app stores in Jan 20, 2025, to enhance pet health monitoring The app enables pet owners detect health issues early through guided smartphone image scans of eyes, skin, or teeth. The AI provides real-time assessments and care recommendations,…

January 2, 2025

Chimerix Reports the Dordaviprone’s NDA Submission to the US FDA for Recurrent H3 K27M-Mutant Diffuse Glioma

Shots: Chimerix has submitted the NDA of dordaviprone (small molecule imipridone targeting the mitochondrial protease ClpP & dopamine receptor D2) to the US FDA, seeking accelerated approval for treating recurrent H3 K27M-mutant diffuse glioma Chimerix has also requested priority review along with a Rare Paediatric Disease PRV as a part of submission, as the…

January 2, 2025

Xgene Pharmaceutical Reports Results from P-IIb Trial of XG005 for Post-Surgical Pain

Shots: The P-IIb trial is evaluating XG005 (1250mg or 750mg, BID, oral) vs PBO in patients (n=450) for managing acute pain after bunionectomy Results showed reduced pain intensity over 72hrs. post-surgery, with mild pain (<4 NRS) in high dose group vs severe pain (>7 NRS) in PBO; delayed rescue medication use of up to…

January 2, 2025

MicuRx Pharmaceutical’s MRX-5 Secures the US FDA’s Orphan Drug Designation for Treating NTM Infections

Shots: The US FDA has granted orphan drug designation (ODD) to MRX-5 for treating non-tuberculous mycobacteria (NTM) infections MRX-5 is a new drug for drug-resistant NTM infections, showing strong antibacterial activity, favorable safety & PK profile in both animal studies & human trial. With minimal interactions, low resistance potential & high oral bioavailability, it…

January 2, 2025

Innovent Biologics Collaborates with Roche to Develop IBI3009 for SCLC

Shots: Innovent & Roche have entered into a collaboration & exclusive license agreement for developing IBI3009 to treat advanced SCLC As per the terms, Roche secures exclusive worldwide rights to develop, manufacture & commercialize IBI3009 plus will lead full development after early-stage studies, conducted jointly. Innovent will get $80M upfront, up to $1B development…

January 2, 2025

HUTCHMED Reports the NMPA’s NDA Acceptance of Orpathys Plus Tagrisso with Priority Review for EGFR-Mutated NSCLC with MET Amplification

Shots: The NMPA has accepted and granted priority review to NDA of Orpathys (savolitinib) + Tagrisso (osimertinib) for treating locally advanced or metastatic EGFR-mutated NSCLC with MET amplification in patients progressed on 1L EGFR inhibitor therapy. HUTCHMED will receive milestone from AstraZeneca Submission was based on P-III (SACHI) study assessing the safety & efficacy…

January 2, 2025

NEWS

GSK’s Nucala (Mepolizumab) Secures the NMPA’s Approval for Treating Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

The China’s NMPA Grants Approval to Genesis Medtech’s Articulation Powered Stapler, iReach Omnia, for Complex Surgeries

Hanx Biopharmaceuticals Reports the First Patient Dosing with HX044 in P-I Clinical Evaluation

Innovent Reports the NMPA’s Approval of Dovbleron (Taletrectinib Adipate Capsule) for Treating ROS1-Positive NSCLC

PettureX Reports the Launch of AI Pet Health Scanner App, Addressing Pet Health

Chimerix Reports the Dordaviprone’s NDA Submission to the US FDA for Recurrent H3 K27M-Mutant Diffuse Glioma

Xgene Pharmaceutical Reports Results from P-IIb Trial of XG005 for Post-Surgical Pain

MicuRx Pharmaceutical’s MRX-5 Secures the US FDA’s Orphan Drug Designation for Treating NTM Infections

Innovent Biologics Collaborates with Roche to Develop IBI3009 for SCLC

HUTCHMED Reports the NMPA’s NDA Acceptance of Orpathys Plus Tagrisso with Priority Review for EGFR-Mutated NSCLC with MET Amplification

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