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Shanghai Henlius Biotech’s HanSiZhuang Shows Positive Results in Phase III ASTRUM-002 Study
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Shanghai Henlius Biotech Inc., (HKG: 2696), a leading biopharmaceutical company in China, has unveiled positive data from the Phase III ASTRUM-002 study. The study assessed the efficacy of its anti-programmed death-1 (PD-1) drug, HanSiZhuang (serplulimab), in combination with chemotherapy for first-line treatment of non-squamous non-small cell lung cancer (nsqNSCLC). The…
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AnHeart Therapeutics Signs Exclusive License Deal with Nippon Kayaku for Taletrectinib
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China-based AnHeart Therapeutics has announced the signing of an exclusive license deal with Japan-based biopharma Nippon Kayaku Co., Ltd. This strategic partnership grants Nippon Kayaku marketing and distribution rights for AnHeart’s leading pipeline candidate, taletrectinib, a next-generation ROS1 inhibitor. Taletrectinib: A Promising Treatment for ROS1-Positive NSCLCTaletrectinib is an oral, potent,…
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BioLineRx Licenses Multiple Myeloma Drug Motixafortide to Guangzhou Gloria Biosciences
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Israel’s BioLineRx has entered into a licensing agreement with Guangzhou Gloria Biosciences Co., Ltd., based in China, focusing on the development of BioLineRx’s multiple myeloma drug, motixafortide. This strategic partnership grants Gloria exclusive rights to develop motixafortide across all indications throughout Asia. As part of the agreement, Gloria is making…
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Allist Pharmaceuticals’ Furmonertinib Receives FDA Breakthrough Therapy Designation for NSCLC
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Shanghai-based biotech Allist Pharmaceuticals Co., Ltd (SHA: 688578) has announced that it has received breakthrough therapy designation (BTD) from the US FDA for its drug candidate furmonertinib. This designation underscores the drug’s potential as a treatment for previously untreated, locally advanced, or metastatic non-small cell lung cancer (NSCLC) with epidermal…
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CDE Grants Priority Review to LaNova’s LM-302, Roche’s Alectinib, and Alphamab’s KN026
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China’s Center for Drug Evaluation (CDE) has indicated that LaNova Medicines’ LM-302, Roche’s (SWX: ROG) alectinib, and Alphamab Oncology’s HER2-targeted bispecific antibody (BsAb) KN026 (anbenitamab) are set for priority reviews. This designation is a significant step that could expedite the availability of these drugs to patients in need. LM-302: A…
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GenFleet Therapeutics’ SLS009 Receives FDA Fast-Track Status for PTCL Treatment
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Shanghai-based biotech GenFleet Therapeutics has announced that its investigational drug SLS009 (GFH009) has received fast-track status from the US FDA for the treatment of recurrent/refractory adult peripheral T-cell lymphoma (PTCL) patients. This CDK9 inhibitor was previously awarded an orphan drug designation (ODD) by the FDA in mid-October, highlighting its potential…
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CStone Pharmaceuticals Receives NMPA Approval for Sugemalimab in R/R ENKTL
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CStone Pharmaceuticals (HKG: 2616), a China-based biopharmaceutical company, has announced that it has received a new indication approval from the National Medical Products Administration (NMPA) for sugemalimab, a programmed death-ligand 1 (PD-L1) inhibitor. The drug is now approved for the treatment of recurrent or refractory extranodal NK/T cell lymphoma (R/R…
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Simcere Pharmaceutical Group Secures Full Approval for Cosela in China
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Simcere Pharmaceutical Group (HKG: 2096), a leading pharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has converted the first conditional approval in China for Cosela (trilaciclib) to full approval. Originally discovered by US biotech G1 Therapeutics Inc, trilaciclib was in-licensed by Simcere in August…
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BMS and Karyopharm Partner to Evaluate Mezigdomide and Xpovio in Relapsed/Refractory Multiple Myeloma
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Bristol Myers Squibb (BMS; NYSE: BMY) has entered into a collaboration and supply agreement with Karyopharm Therapeutics (NASDAQ: KPTI) to evaluate the combination of BMS’s cereblon E3 ligase modulator (CELMoD) candidate, mezigdomide, with Karyopharm’s first-in-class Exportin 1 (XPO1) inhibitor, Xpovio (selinexor), plus dexamethasone. This combination is targeted at relapsed/refractory multiple…
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AbbVie’s Q3 2023 Report Shows 6.0% YOY Decline in Net Revenues
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AbbVie (NYSE: ABBV) released its Q3 2023 financial report last week, revealing a 6.0% year-on-year (YOY) decline in net revenues for the first nine months of the year, amounting to USD 40.0 billion. The decrease was attributed to underperformance across most business areas, with the exception of neuroscience, which reported…
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Alphamab Oncology and 3D Medicines Gain FDA Approval for Envafolimab Phase III Trial
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Partners Alphamab Oncology (HKG: 9966) and 3D Medicines (HKG: 1244) have announced that they have received approval from the US Food and Drug Administration (FDA) to conduct a Phase III clinical study for envafolimab (KN035) in proficient mismatch repair (fMMR) advanced or recurrent endometrial cancer combined with lenvatinib. This approval…
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Fosun Pharma Gains NMPA Approval for Clinical Trials of HLX42 and HLX43 ADCs
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196) has announced that it has received approval from the National Medical Products Administration (NMPA) in China to conduct separate clinical studies for HLX42 and HLX43. These two pipeline candidates are antibody drug conjugates (ADCs) co-developed by subsidiary Shanghai Henlius Biotech Inc., (HKG:…
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Junshi Biosciences’ PD-1 Inhibitor Loqtorzi Approved by FDA for Nasopharyngeal Carcinoma
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China-based Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that the US FDA has approved its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab), for the treatment of adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC). The approval marks a significant milestone as Loqtorzi becomes the first…
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TG ImmunoPharma’s Bispecific Antibody TGI-6 Approved for Phase I Clinical Study by NMPA
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China-based TG ImmunoPharma Co., Ltd has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study for its bispecific antibody (BsAb) TGI-6 in China. This approval marks a significant milestone in the development of innovative cancer treatments within the country.…
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Wyze Biotech’s RJMty19 Injection Accepted for CDE Review for r/r B-Cell NHL
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Wyze Biotech Co., Ltd, a Guangdong-based developer of off-the-shelf universal DNT cell therapies, has announced that an investigational new drug (IND) filing for its immune cell product RJMty19 injection has been accepted for review by China’s Center for Drug Evaluation (CDE). The therapy is intended for assessment as a treatment…
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Shanghai Henlius Biotech and Intas Pharmaceuticals Ink New Licensing Deal for PD-1 mAb
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China’s Shanghai Henlius Biotech Inc., (HKG: 2696) has announced a new licensing agreement with India-based Intas Pharmaceuticals Ltd, granting Intas exclusive development and commercialization rights to its anti-programmed death-1 (PD-1) monoclonal antibody (mAb) HanSiZhuang (serplulimab) in Europe and India. This strategic partnership further expands the global reach of Henlius’s innovative…
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Takeda’s Global Revenues Grow: Strong Performance in Plasma Therapies and Gastroenterology
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Japan-based pharmaceutical giant Takeda (TYO: 4502) has released its financial results for the 6-month period ending September 30, 2023, with global revenues hitting JPY 2.1 trillion (USD 14.0 billion). This represents a 6.4% year-on-year (YOY) increase in reported terms, or a more modest 1.4% growth at constant exchange rates (CER).…
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Abbisko Therapeutics Gets NMPA Approval for Phase I Study of ABSK112 in NSCLC
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Shanghai-based biotechnology firm Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval from China’s National Medical Products Administration (NMPA) to initiate a Phase I clinical study for its investigational drug, ABSK112. This next-generation EGFR inhibitor, which targets the Exon20ins mutation, is set to be evaluated as…
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Sinotau Pharmaceutical Group Secures Rights to Blue Earth Diagnostics’ Flotufolastat in China
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Sinotau Pharmaceutical Group, a Beijing-based nuclear medicine enterprise, has entered into a licensing agreement with UK molecular imaging company Blue Earth Diagnostics, an indirect subsidiary of Bracco Imaging S.p.A. Through this deal, Sinotau will gain development, manufacturing, and commercialization rights to Blue Earth’s PSMA targeted PET imaging agent, Flotufolastat (18F).…
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Huadong Medicine’s Elahere Accepted for NMPA Review in China for Ovarian Cancer Treatment
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that the National Medical Products Administration (NMPA) has accepted the market filing for its antibody drug conjugate (ADC) Elahere (mirvetuximab soravtansine), targeting folate receptor α (FRα). This marks a significant step towards making the treatment available for patients in China. Acquisition…
