-
Immunofoco’s IMC008 Earns Orphan Drug Designation for Pancreatic Cancer from FDA
•
Suzhou-based cell therapy developer Immunofoco has announced that it has received orphan drug designation (ODD) from the US Food and Drug Administration for its next-generation autologous CAR-T therapy, IMC008, for the treatment of pancreatic cancer. This follows the company’s first ODD status granted for gastric cancer in the country less…
-
Shanghai Haihe Pharmaceutical’s Glumetinib Filed for Marketing in Japan for NSCLC Treatment
•
Shanghai Haihe Pharmaceutical Co., Ltd has announced the filing for marketing approval in Japan for its Category 1 product, glumetinib, indicated for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET 14 exon mutation. Glumetinib’s Development and EfficacyCo-developed by Haihe Pharma and the Chinese Academy…
-
Luye Pharma’s Botawei Receives NMPA Approval for Breast Cancer Treatment
•
Luye Pharma Group (HKG: 2186) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its injectable goserelin acetate in microsphere form, trade-named Botawei, for the treatment of breast cancer in premenopausal and perimenopausal women eligible for hormone therapy. Botawei: A Pioneering Treatment for…
-
Janssen’s Rybrevant Combo Meets Primary Endpoint in Advanced NSCLC Study
•
Janssen, a subsidiary of Johnson & Johnson (J&J; NYSE: JNJ), has released an update on a late-stage study for its bispecific antibody (BsAb) Rybrevant (amivantamab). The study investigated the combination of Rybrevant with tyrosine kinase inhibitor (TKI) lazertinib and chemotherapy in treating advanced or metastatic non-small cell lung cancer (NSCLC)…
-
Henan Zhongshuai’s Dexmethylphenidate Hydrochloride Capsules Target Priority Review for Pediatric ADHD
•
Henan Zhongshuai Pharmaceutical Co., Ltd., a China-based pharmaceutical company, is poised to secure priority review status for its dexmethylphenidate hydrochloride sustained release capsules, which are being developed for potential pediatric use. The molecule is intended to treat attention deficit hyperactivity disorder (ADHD) in children. Phase III Clinical Study and EfficacyThe…
-
Amneal Pharmaceuticals Receives China Approval for Sevelamer Carbonate
•
US-based Amneal Pharmaceuticals Inc. (NYSE: AMRX) has announced that it has received approval from the Chinese market for its sevelamer carbonate, marking the company’s inaugural product approval in China. The drug is indicated for the treatment of hyperphosphatemia in patients with chronic kidney disease who are undergoing dialysis. Sevelamer represents…
-
CSPC Pharmaceutical’s Narlumosbart Approved by NMPA for Bone Giant Cell Tumors
•
CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that its subsidiary, Shanghai JMT Biotechnology Co., Ltd, has received marketing approval from the National Medical Products Administration (NMPA) for narlumosbart (JMT103), an anti-RANKL monoclonal antibody (mAb), to treat giant cell tumors of bone that are inoperable or may lead to severe…
-
Jiangsu Hengrui’s HER2-Targeted ADC SHR-A1811 Aims for CDE’s BTD Status
•
China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that its HER2 targeted antibody-drug conjugate (ADC), SHR-A1811, is on track to receive breakthrough therapy designation (BTD) status from the Center for Drug Evaluation (CDE) in China. This designation is for the treatment of HER2 positive advanced colorectal cancer, marking…
-
Genentech Files for FDA Approval of Crovalimab for PNH, Challenging Soliris
•
Swiss pharmaceutical giant Roche’s subsidiary, Genentech (SWX: ROG), has submitted its anti-C5 investigational drug, crovalimab, to the US Food and Drug Administration (FDA) for the treatment of the rare disease paroxysmal nocturnal hemoglobinuria (PNH). The filing is bolstered by Phase III clinical data that demonstrates crovalimab’s non-inferiority and a similar…
-
Hainan Haiyao Concludes Phase I Clinical Study for PaiEnJiaBin, a Novel KCNQ Agonist
•
China-based Hainan Haiyao Co., Ltd (SHE: 000566) has announced the conclusion of Phase I clinical studies for PaiEnJiaBin, a Category 1 chemical drug co-developed with the Shanghai Institute of Materia Medica. PaiEnJiaBin is a next-generation KCNQ potassium channel agonist, with no similar products approved globally, and is being developed to…
-
MSD’s Gardasil 9 HPV Vaccine Demonstrates 10-Year Efficacy in Adolescents
•
Merck, Sharp & Dohme (MSD; NYSE: MRK) has released long-term effectiveness data for its recombinant human papillomavirus (HPV) 9-valent vaccine, Gardasil 9, in minors aged between 9 and 15 years old. The results indicate that the immunogenicity generated by the vaccine persisted for 10 years after the third and final…
-
Neurophth Biotechnology’s NFS-05 Gene Therapy Gets Australian Clinical Trial Approval for ADOA
•
China-based gene therapy specialist Neurophth Biotechnology Ltd has announced that it has received clinical trial approval from the Therapeutic Goods Administration of Australia for its candidate drug NFS-05. The therapy is set to be assessed as a treatment for autosomal dominant optic atrophy (ADOA), an inherited optic neuropathy. Understanding Autosomal…
-
Harbin Gloria Pharmaceuticals’ Zimberelimab Receives NMPA Approval for Cervical Cancer Treatment
•
China-based Harbin Gloria Pharmaceuticals Co., Ltd (SHE: 002437) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its programmed cell death-1 (PD-1) monoclonal antibody (mAb) zimberelimab. The drug is indicated for the treatment of recurrent or metastatic cervical cancer patients with positive PD-L1…
-
Seagen and Genmab Announce Positive Phase III Results for Tivdak in Cervical Cancer
•
Seagen (NASDAQ: SGEN), currently in the process of being acquired by Pfizer (NYSE: PFE), and its partner Genmab (NASDAQ: GMAB), have announced the achievement of the primary endpoint in a Phase III trial for their antibody-drug conjugate (ADC) Tivdak (tisotumab vedotin). The trial focuses on patients with recurrent or metastatic…
-
SinoMab BioScience’s Suciraslimab Files for Market Approval in China for Rheumatoid Arthritis
•
Hong Kong-based biotech company SinoMab BioScience Ltd (HKG: 3681) has announced that a market approval filing has been submitted for its suciraslimab (SM03) to the National Medical Products Administration (NMPA) in China. The CD22 monoclonal antibody (mAb) is seeking its first indication approval as a treatment for rheumatoid arthritis (RA).…
-
Columbia University Study Weighs Cost-Effectiveness of Weight-Loss Treatments for Adolescents
•
Researchers at US Columbia University have published the results of a study estimating the cost-effectiveness of Novo Nordisk’s (NYSE: NVO) injections Wegovy (semaglutide) and Saxenda (liraglutide), as well as Vivus’s (NASDAQ: VVUS) pill Qsymia (phentermine + topiramate) for weight-loss interventions in adolescents. The study utilized a simulated cohort of 100,000…
-
BDgene Technology Announces Clinical Milestone for CRISPR-Cas9 Gene Therapy in HSK
•
Gene therapy specialist Shanghai BDgene Technology Co., Ltd has announced the conclusion of three clinical research treatments using its HELP technology, based on the CRISPR-Cas9 gene editing tool, for herpes simplex keratitis (HSK). Preliminary positive results have been published in the journal Molecular Therapy, in an article titled “In Vivo…
-
Sihuan Pharmaceutical’s Birociclib NDA Accepted for Review by China’s NMPA
•
China’s Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) has announced that the National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for birociclib, a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, for review. The drug is intended for the treatment of HR+/HER2- advanced breast cancer in patients who have…
-
Jointown Medical’s COVID-19 Drug Candidate SHEN211 Accepted for Review by NMPA
•
China-based Jointown Medical Devices Group Co., Ltd (SHA: 600998) has announced that its clinical trial filing for the Category 1 COVID-19 drug candidate, SHEN211, has been accepted for review by China’s National Medical Products Administration (NMPA). SHEN211 is an oral broad-spectrum anti-novel coronavirus non-peptide 3CL protease inhibitor, co-developed by a…
