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Sino Biopharmaceutical Submits NDA for Anlotinib and Penpulimab Combo in HCC to NMPA
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China-based Sino Biopharmaceutical Ltd (HKG: 1177) has announced the submission of a New Drug Application (NDA) to the National Medical Products Administration (NMPA) for its combination therapy of anlotinib and penpulimab in first-line advanced hepatocellular carcinoma (HCC). Phase III Study Data Supports NDA FilingThe filing is supported by data from…
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NMPA Approves Alpha Biopharma’s Zorifertinib for First-Line NSCLC Treatment with CNS Metastases
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The National Medical Products Administration (NMPA) has granted approval to China-based Alpha Biopharma’s zorifertinib, commercially known as Zorifer, for the treatment of first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) substitution mutation and central nervous…
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AstraZeneca’s Tagrisso Receives Positive CHMP Opinion for EGFR-Mutated NSCLC
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AstraZeneca (AZ, NASDAQ: AZN), a leading UK pharmaceutical company, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued positive opinions for its drug Tagrisso (osimertinib). The EGFR-tyrosine kinase inhibitor (EGFR-TKI) is now recommended for approval to treat adult patients…
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Janssen-Cilag’s Lazcluze-Rybrevant Combo Receives Positive EMA Opinion for NSCLC Treatment
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Janssen-Cilag International NV, a subsidiary of the US pharmaceutical giant Johnson & Johnson (J&J; NYSE: JNJ), has announced that it has received positive opinions from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) regarding the combination of Lazcluze (lazertinib) and Rybrevant (amivantamab-vmjw). This combination therapy…
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Dizal Pharmaceutical Submits NDA to FDA for Sunvozertinib as NSCLC Therapy
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Dizal Pharmaceutical Co., Ltd (SHA: 688192), a Chinese pharmaceutical company, has announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for sunvozertinib, a targeted therapy for lung cancer. The company is seeking approval for the treatment of locally advanced or metastatic non-small…
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HutchMed to Receive $20 Million Milestone Payment from Takeda for Fruzaqla Sales
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China-based HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) is poised to receive a USD 20 million milestone payment from its Japanese partner Takeda (TYO: 4502; NYSE: TAK), following the achievement of over USD 200 million in sales of Fruzaqla (fruquintinib) for metastatic colorectal cancer (CRC). Fruquintinib, a selective oral inhibitor…
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LaNova Medicines Regains Rights to Claudin 18.2 Targeting ADC LM-302 from BMS
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LaNova Medicines Ltd, a Shanghai-based developer of cancer therapies, has announced the reclamation of control over LM-302, an antibody drug conjugate (ADC) targeting Claudin 18.2, from US pharmaceutical giant Bristol-Myers Squibb (BMS; NYSE: BMY). LaNova had previously signed an agreement with Turning Point Therapeutics, Inc. (TPTX.US) in May 2022 to…
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Sino Biopharmaceutical’s Anlotinib Receives Ninth Indication Approval from China’s CDE for Soft-Tissue Sarcoma
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Sino Biopharmaceutical Ltd (HKG: 1177), a leading pharmaceutical company in China, has announced that it has received another indication approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for its oral multi-target kinase inhibitor, anlotinib. The request is for anlotinib to be used in…
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Jiangsu Hengrui Resubmits Application for Camrelizumab Combo in HCC to FDA
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a prominent pharmaceutical company based in China, has announced a new attempt at a market filing with the US Food and Drug Administration (FDA) for its programmed death-1 (PD-1) monoclonal antibody (mAb) camrelizumab, in combination with the small-molecule targeted cancer therapy apatinib, as…
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Dizal Pharmaceutical’s Sunvozertinib Earns Breakthrough Designation for NSCLC from China’s NMPA
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Dizal Pharmaceutical Co., Ltd (SHA: 688192), a biopharmaceutical company based in China, has announced that it has received Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) for its next-generation epidermal growth factor receptor (EGFR) inhibitor, sunvozertinib. This designation is in relation to the drug’s potential use as…
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Ascentage Pharma Receives Approval for Two Phase III Trials of APG-2449 in NSCLC
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China-based biopharmaceutical company Ascentage Pharma (HKG: 6855) has announced that it has received approval from the Center for Drug Evaluation of the National Medical Products Administration (NMPA) to conduct two separate Phase III clinical studies assessing its investigational drug APG-2449. The trials will evaluate the FAK/ALK/ROS1 tyrosine kinase inhibitor (TKI)…
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Innovent Biologics and ASK Pharma Forge Strategic Partnership for Limertinib in Lung Cancer Treatment
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China-based Innovent Biologics Inc. (HKG: 1801) and Jiangsu Aosaikang Pharmaceutical Co., Ltd (ASK Pharma, SHE: 002755) have announced a strategic collaboration and licensing agreement focused on ASK’s limertinib, a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) designed for lung cancer treatment. Under the terms of the deal,…
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InnoCare Pharma’s Orelabrutinib Achieves Milestone in SLE Clinical Trial Enrollment
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InnoCare Pharma announced on October 4, 2024, that it has completed patient enrollment in a Phase II clinical trial for its novel BTK inhibitor, Orelabrutinib, for the treatment of Systemic Lupus Erythematosus (SLE). This randomized, double-blind, placebo-controlled, multicenter Phase IIb clinical study is designed to evaluate the efficacy and safety…
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Dizal Pharmaceutical’s Surufatinib Earns CDE Consideration for Breakthrough Therapy in EGFR exon20ins NSCLC
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Dizal Pharmaceutical, a biopharmaceutical company based in China, has announced that the Center for Drug Evaluation (CDE) in China is considering its drug candidate DZD9008 for breakthrough therapy status. The drug is designed to treat patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not received…
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AstraZeneca’s Tagrisso Secures FDA Approval for Unresectable Stage III EGFRm NSCLC
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AstraZeneca (NASDAQ: AZN, LON: AZN), a UK-based pharmaceutical giant, has announced that it has received a new indication approval from the US Food and Drug Administration (FDA) for its non-small cell lung cancer (NSCLC) drug Tagrisso (osimertinib). The FDA has approved Tagrisso for the treatment of adult patients with unresectable,…
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Janssen and Yuhan Halt Development of Next-Gen EGFR Inhibitor for NSCLC
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Yuhan, a South Korean pharmaceutical company, and its partner Janssen Biotech, a subsidiary of US healthcare giant Johnson & Johnson (J&J; NYSE: JNJ), have reportedly decided to halt the development of a next-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) for non-small cell lung cancer (NSCLC). This strategic…
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Dizal Pharmaceutical’s Sunvozertinib Shows Promising Results in WU-KONG Series Study at ESMO 2024
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Dizal Pharmaceutical Co., Ltd (SHA: 688192), a biopharmaceutical company based in China, has presented updates on the WU-KONG series study for its next-generation epidermal growth factor receptor (EGFR) inhibitor, sunvozertinib (DZD9008), at the 2024 European Society of Medical Oncology (ESMO) Congress. Sunvozertinib received approval in China in August of the…
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Ascentage Pharma’s Olverembatinib Shows Promise in SDH-Deficient GIST at ESMO Congress
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Ascentage Pharma (HKG: 6855), a biopharmaceutical company based in China, has announced the presentation of clinical study results for its drug olverembatinib (HQP1351) at the 2024 European Society of Medical Oncology (ESMO) Congress. The study focused on patients with succinate dehydrogenase-deficient gastrointestinal stromal tumor (GIST), a rare and aggressive form…
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Sanofi’s Tolebrutinib Shows Mixed Results in Phase III Multiple Sclerosis Trials
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PARIS—French pharmaceutical giant Sanofi (Nasdaq: SNY; EURONEXT: SAN) has reported mixed outcomes from three Phase III trials for its Bruton’s tyrosine kinase (BTK) inhibitor, tolebrutinib, as a treatment for multiple sclerosis (MS). The drug candidate achieved success in the HERCULES study, where it met the primary endpoint of delaying the…
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Jiangsu Simcere Acquires Exclusive Rights to TargetRx’s TGRX-326 in Licensing Deal
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SHENZHEN—Shenzhen TargetRx, Inc., a leading developer of small-molecule kinase inhibitors, has entered into a licensing agreement with Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096), a fellow Chinese pharmaceutical company. The deal concerns TargetRx’s TGRX-326, an ALK/ROS1 dual receptor tyrosine kinase inhibitor currently at the clinical stage. According to the agreement,…
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HutchMed Halts China Filing for Gastric Cancer Drug Fruquintinib Following Regulatory Feedback
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HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013), a China-based biopharmaceutical company, has announced the withdrawal of its New Drug Application (NDA) for fruquintinib, a VEGFR inhibitor, in combination with paclitaxel for the second-line treatment of advanced gastric or gastroesophageal junction adenocarcinoma (GC/GEJ) in China. The decision to withdraw was made…
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Sino Biopharmaceutical’s Anlotinib-Penpulimab Combo Meets Milestone in Phase III HCC Study
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HONG KONG—Sino Biopharmaceutical Ltd (HKG: 1177), a leading biopharmaceutical company based in China, has announced the successful completion of a pre-set interim analysis in its Phase III clinical study. The study combines anlotinib with penpulimab as a first-line treatment for advanced hepatocellular carcinoma (HCC), achieving the optimal efficacy thresholds for…
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Hangzhou Biosunpharma’s OB756 New Drug Application Accepted for Myelofibrosis Treatment by China’s NMPA
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Hangzhou Biosunpharma Co., Ltd. has announced that the National Medical Products Administration (NMPA) has accepted for review the New Drug Application (NDA) for its investigational compound OB756. The company is seeking regulatory approval for the treatment of patients with medium to high-risk myelofibrosis (MF). OB756 is a novel JAK2 inhibitor…
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Henlius Biotech Secures Exclusive Rights to Commercialize Convalife’s Generic Neratinib in China and Abroad
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Shanghai Henlius Biotech Inc., (HKG: 2696), a leading biopharmaceutical company based in China, has entered into a licensing agreement with fellow Chinese firm Convalife Pharmaceuticals. Henlius has secured the exclusive commercialization rights for Convalife’s generic version of Puma Biotechnology Inc’s neratinib in China, along with exclusive negotiation and conditional licensing…
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Shanghai Henlius Biotech Secures Exclusive Rights to Convalife Pharmaceuticals’ Generic Neratinib in China
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SHANGHAI—Shanghai Henlius Biotech Inc., (HKG: 2696), a leading biopharmaceutical company based in China, has entered into a licensing agreement with fellow Chinese firm Convalife Pharmaceuticals. The deal grants Henlius the exclusive commercialization rights to Convalife’s generic version of Puma Biotechnology Inc’s neratinib in China, along with exclusive negotiation and conditional…
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Qilu Pharmaceutical Gains Approval for Generic Dasatinib, Expanding CML Treatment Options in China
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Qilu Pharmaceutical, based in China, has received marketing approval for its generic version of Bristol-Myers Squibb’s (BMS) Sprycel (dasatinib) in China. This second-generation BCR-ABL tyrosine kinase inhibitor (TKI) is now available for the treatment of patients with Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) who are resistant to or intolerant…
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Nanjing Sanhome’s Oritinib Ships Widely for EGFR-mutated NSCLC Treatment in China
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Nanjing Sanhome Pharmaceutical Co., Ltd, a notable player in the pharmaceutical sector, has announced the widespread distribution of its Category 1 chemical drug, oritinib, across key regions in China, including Jiangsu, Shanghai, Beijing, Henan, and Inner Mongolia. The drug has been made available to lung cancer specialists who are now…
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Boehringer Ingelheim’s Zongertinib Earns Breakthrough Designation in China for HER2-Mutated NSCLC
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Boehringer Ingelheim, a leading German pharmaceutical company, has received a significant endorsement from China’s Center for Drug Evaluation (CDE) with the breakthrough therapy designation (BTD) for its investigational HER2-targeted tyrosine kinase inhibitor (TKI), zongertinib (BI 1810631). This designation underscores the potential of zongertinib in treating adult patients with HER2-mutated advanced,…
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Hansoh Pharmaceutical Secures Rights to Lupeng’s BTK Inhibitor LP-168 in Licensing Deal
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Jiangsu Hansoh Pharmaceutical Co., Ltd (HKG: 3692), a leading pharmaceutical company based in China, has entered into a licensing agreement with fellow Chinese firm Lupeng Pharmaceutical Ltd for the next-generation Bruton’s tyrosine kinase (BTK) inhibitor, LP-168. According to the terms of the agreement, Hansoh will assume responsibility for research and…
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Sino Biopharmaceutical’s Benmelstobart Files for New Indication in China for Advanced RCC Treatment
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Sino Biopharmaceutical Ltd (HKG: 1177), a leading biopharmaceutical company based in China, has announced that the Center for Drug Evaluation (CDE) in China has accepted for review a new indication filing for its anti-programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb), benmelstobart (TQB2450). The filing seeks regulatory approval for the use…
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Amoy Diagnostics’ APACE Receives Japanese Approval as Companion Diagnostic for MET-Inhibiting Therapies
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Amoy Diagnostics Co., Ltd (AmoyDx, SHE: 300685), a Chinese diagnostics company, has announced that it has received two new indication approvals in Japan for its APACE (also known as PCR-11 gene product), a multi-target rapid screening product designed for lung cancer detection. The product is now approved as a companion…
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Hansoh Pharmaceutical’s EGFR Inhibitor Ameile Files for Adjuvant Therapy Approval with NMPA
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Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692), a leading biopharmaceutical company based in China, has announced the submission of a market filing application for its epidermal growth factor receptor (EGFR) inhibitor, Ameile (almonertinib), to the National Medical Products Administration (NMPA). The application seeks approval for Ameile as an adjuvant therapy…
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Sino Biopharmaceutical’s Anlotinib Achieves Milestones in Phase III Trial for Soft-Tissue Sarcoma
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Sino Biopharmaceutical Ltd (HKG: 1177), a leading pharmaceutical company based in China, has announced positive interim data from a Phase III clinical study for its drug anlotinib. The study combines anlotinib with chemotherapy as a first-line treatment for advanced unresectable or metastatic soft-tissue sarcoma. The Independent Data Monitoring Committee (IDMC)…
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KeChow Pharma’s Keluping, First NRAS Mutant Melanoma Therapy, Hits the Market
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Shanghai-based KeChow Pharma has announced the official market launch of its groundbreaking drug, Keluping (tunlametinib), the world’s first targeted therapy designed specifically for NRAS mutant melanoma. Tunlametinib, a novel ATP noncompetitive MEK inhibitor that targets NRAS mutations, received marketing approval in China in March this year. The drug was granted…
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Allist Pharmaceuticals Faces Arbitration Over Promotion Agreement for Furmonertinib
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Allist Pharmaceuticals Co., Ltd, a Shanghai-based biopharmaceutical company, has announced that it has received a notice of the initiation of arbitration from the Shanghai International Economic and Trade Arbitration Commission. The applicant in this matter is Shanghai Fosun Pharmaceutical Group Co., Ltd (SHA.600196; HKEX.02196), which is seeking the cancellation of…
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Ascentage Pharma Receives USD 100 Million Option Rights Payment from Takeda
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Ascentage Pharma (HKG: 6855), a biopharmaceutical company based in China, has announced that it has received a USD 100 million option rights payment from its Japanese partner Takeda (TYO: 4502), in accordance with an exclusive option agreement signed earlier last month. In June 2024, Takeda and Ascentage entered into an…
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Dizal Pharmaceutical’s Golidocitinib Breaks Record with Rapid Market Launch in China
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Dizal Pharmaceutical Co., Ltd (SHA: 688192), a biopharmaceutical company based in China, has seen its drug golidocitinib go from marketing approval to first prescriptions in a record time of just two days in China. This marks a significant milestone, as golidocitinib is the first and only approved Janus kinase 1…
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Shanghai Haihe Pharmaceutical’s Glumetinib Earns Marketing Approval in Japan for NSCLC Treatment
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Shanghai Haihe Pharmaceutical Co., Ltd, a Chinese pharmaceutical company, has announced that it has received marketing approval in Japan for its MET targeted tyrosine kinase inhibitor (TKI), glumetinib, for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with a MET 14 exon mutation. The approval is…
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Dizal Pharmaceutical’s Golidocitinib Wins NMPA Approval for Relapsed/Refractory PTCL
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Dizal Pharmaceutical Co., Ltd (SHA: 688192), a spin-off from AstraZeneca China established in 2017, has announced that the National Medical Products Administration (NMPA) has granted approval for its drug golidocitinib. The drug is indicated for the treatment of adult patients with relapsed or refractory (r/r) peripheral T-Cell lymphoma (PTCL) who…
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Nanjing Sanhome’s Oritinib Wins NMPA Approval for EGFR T790M Positive NSCLC
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Nanjing Sanhome Pharmaceutical Co., Ltd has received approval from the National Medical Products Administration (NMPA) for its Category 1 chemical drug oritinib, indicated for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) positive for EGFR T790M mutation in patients who have confirmed disease progression during or…
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Shenzhen Chipscreen Biosciences Receives NMPA Approval for Chiauranib Phase II Trial in Pancreatic Cancer
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Shenzhen Chipscreen Biosciences Co., Ltd (SHA: 688321), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study for its Category 1 innovative drug, chiauranib. The drug will be evaluated in combination with chemotherapy…
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FDA Approves Broadened Use of BMS’ Next-Gen TKI Augtyro for Advanced Solid Tumors
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The US Food and Drug Administration (FDA) has granted Bristol Myers Squibb (BMS; NYSE: BMY) an accelerated approval for its next-generation tyrosine kinase inhibitor (TKI), Augtyro (repotrectinib), for the treatment of locally advanced, metastatic, or unresectable NTRK fusion-positive solid tumors. This decision follows the drug’s progression after treatment or in…
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Takeda Secures Global Rights to Ascentage Pharma’s Olverembatinib Outside of China and Select Territories
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Takeda Pharmaceuticals, a leading biopharmaceutical company based in Japan (TYO: 4502), has entered into an option agreement with China-based Ascentage Pharma (HKG: 6855), securing exclusive development and commercialization rights for olverembatinib, a third-generation BCR-ABL tyrosine kinase inhibitor (TKI), in markets outside of China, Hong Kong, Macau, Taiwan, and Russia. The…
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Ascentage Pharma Gets Green Light for Global Phase III Trial of Olverembatinib in SDH-Deficient GIST
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Ascentage Pharma (HKG: 6855), a biopharmaceutical company based in China, has announced that it has received approval from the Center for Drug Evaluation (CDE) in China to initiate a global regulatory Phase III study for its Category 1 drug olverembatinib. The study aims to evaluate the efficacy of olverembatinib in…
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Novartis’s Tabrecta Earns NMPA Nod for MET-Positive Advanced NSCLC in China
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Swiss pharmaceutical titan Novartis has secured marketing approval from China’s National Medical Products Administration (NMPA) for its drug Tabrecta (capmatinib), intended for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring a mesenchymal–epithelial transition (MET) exon 14 skipping mutation, who have not received…
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AstraZeneca’s Tagrisso Achieves Milestone Progression-Free Survival in Late-Stage Lung Cancer Study
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AstraZeneca (AZ; NASDAQ: AZN), a UK-based pharmaceutical and biopharmaceutical company, has announced preliminary results from a late-stage study for its EGFR inhibitor, Tagrisso (osimertinib), in patients with unresectable, stage III EGFR-mutated non-small cell lung cancer (NSCLC) characterized by exon 19 deletions or exon 21 mutations. The trial successfully met its…
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Ascentage Pharma’s APG-2449 Shows Positive Results in ROS1 and ALK Positive NSCLC at ASCO 2024
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Ascentage Pharma (HKG: 6855), a biopharmaceutical company based in Suzhou, has announced a wall poster presentation showcasing the latest data for its FAK/ALK/ROS1 inhibitor APG-2449 at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. The study determined the recommended Phase II dosage (RP2D) of APG-2449 to be 1200…
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Shanghai Fosun Pharma’s FCN-159 File for Dendritic and Histiocytic Tumors Accepted by China’s NMPA
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that the National Medical Products Administration (NMPA) has accepted its market approval filing for the novel small-molecule drug FCN-159 for review. The drug is being considered for the treatment of dendritic and histiocytic tumors, indications that have previously…
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Sino Biopharmaceutical’s Benmelstobart Shows Positive Results in RCC Combination Therapy Study
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Sino Biopharmaceutical Ltd (HKG: 1177), a leading biopharmaceutical company based in China, has announced positive interim analysis results from a Phase III clinical study for its anti-programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb) benmelstobart (TQB2450) in combination with anlotinib for the treatment of advanced unresectable or metastatic renal cell carcinoma…
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BeiGene’s Brukinsa Secures Conditional Approval in China for R/R Follicular Lymphoma
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BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a leading biopharmaceutical company based in China, has received conditional approval from the National Medical Products Administration (NMPA) for its Bruton’s tyrosine kinase (BTK) inhibitor, Brukinsa (zanubrutinib). The approval is for the use of Brukinsa in combination with the CD20-targeted obinutuzumab for…
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Zai Lab’s ROS1 Inhibitor Augtyro Earns NMPA Nod for Advanced NSCLC Treatment
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Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688), a biopharmaceutical company based in China, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its drug Augtyro (repotrectinib). This treatment is intended for adult patients with locally advanced or metastatic ROS1-positive non-small-cell lung cancer (NSCLC).…
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Chia Tai Tianqing’s PD-L1 Antibody Benmelstobart Wins NMPA Nod for ES-SCLC
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China-based Chia Tai Tianqing has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its anti-programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb) benmelstobart (TQB2450). The drug is approved as a first-line treatment for extensive stage small cell lung cancer (ES-SCLC) in combination with anlotinib…
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Jiangsu Hengrui Medicine Gets NMPA Go-Ahead for Camrelizumab Combination Therapy Study in Pancreatic Cancer
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a multi-center, randomized, controlled Phase II/III clinical study. The study will assess the efficacy and safety of its programmed death-1 (PD-1)…
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Dizal Pharmaceutical’s Sunvozertinib Earns FDA Breakthrough Therapy Designation for NSCLC
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Dizal Pharmaceutical Co., Ltd (SHA: 688192), a leading Chinese pharmaceutical company, has announced that its next-generation epidermal growth factor receptor (EGFR) inhibitor, sunvozertinib, has received breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA). This designation is in recognition of sunvozertinib’s potential as a first-line treatment for…
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Jiangsu Hengrui’s Fluzoparib Receives Breakthrough Therapy Designation for HER2-Negative Breast Cancer
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Jiangsu Hengrui Medicine Co., Ltd. (SHA: 600276), a China-based pharmaceutical company, has announced that its indication approval filing for fluzoparib—a poly (ADP-ribose) polymerase (PARP) inhibitor—has been awarded breakthrough therapy designation (BTD) by China’s Center for Drug Evaluation (CDE). The designation applies to fluzoparib, both as a monotherapy and in combination…
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BeiGene and GenFleet Join Forces for DLBCL Trial Combining Brukinsa and GFH009
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BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a China-based biotechnology company, has entered into a clinical research and drug supply cooperation agreement with fellow Chinese firm GenFleet Therapeutics. The partnership will kick off a Phase Ib/II clinical trial to evaluate the safety and efficacy of a combination regimen featuring…
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HutchMed’s Orpathys Files for Expanded Indication in NSCLC Treatment in China
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HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) has announced that the National Medical Products Administration (NMPA) in China is currently reviewing a new market approval filing for Orpathys (savolitinib), a MET inhibitor co-developed with AstraZeneca. The company is seeking a new indication for the drug as a first-line treatment for…
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Nuvation Bio to Acquire AnHeart Therapeutics in All-Stock Deal Amid Biotech Pressures
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U.S.-based biotech Nuvation Bio Inc. (NYSE: NUVB) has announced a definitive agreement to acquire China-based AnHeart Therapeutics Inc. in an all-stock transaction, which has received approval from the boards of both companies. The deal is contingent upon approval from AnHeart’s shareholders and is anticipated to close in the second quarter…
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FDA Grants Accelerated Approval for Takeda’s Iclusig in Newly Diagnosed Ph+ ALL
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The U.S. Food and Drug Administration (FDA) has granted accelerated indication extension approval to Japan’s Takeda Pharmaceutical Company (TYO: 4502) for its tyrosine kinase inhibitor (TKI) Iclusig (ponatinib) in combination with chemotherapy for the treatment of newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). This follows the drug’s previous…
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KeChow Pharma Secures Conditional Approval for HL-085, a First-of-Its-Kind MEK Inhibitor for Advanced Melanoma
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Shanghai-based KeChow Pharma has received conditional marketing approval from the National Medical Products Administration (NMPA) for its Category 1 drug HL-085, aimed at treating advanced melanoma with NRAS mutations in patients who have experienced failure with anti-PD-1/PD-L1 therapies. HL-085 is a groundbreaking ATP non-competitive MEK inhibitor that specifically targets NRAS…
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Betta Pharmaceuticals’ Ensartinib Accepted for FDA Review for First-Line ALK+ NSCLC Treatment
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Betta Pharmaceuticals (SHE: 300558), a pharmaceutical company based in China, has announced that the market filing for its ensartinib, an anaplastic lymphoma kinase (ALK) inhibitor co-developed with its affiliate Xcovery, has been accepted for review by the US Food and Drug Administration (FDA). The drug is intended for the first-line…
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Innovent Biologics’ Taletrectinib Receives Second NDA Acceptance in China for ROS1 Positive NSCLC
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Innovent Biologics Inc., (HKG: 1801), a biopharmaceutical company based in China, has announced that the Center for Drug Evaluation (CDE) in China has accepted a second New Drug Application (NDA) for its investigational drug taletrectinib. This next-generation tyrosine kinase inhibitor (TKI) targets ROS1 and NTRK fusion mutations and is currently…
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BeiGene’s Brukinsa Outperforms Acalabrutinib in MAIC for Relapsed/Refractory CLL, Says BeiGene
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BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced the results of a matching-adjusted indirect comparison (MAIC) between its Bruton’s tyrosine kinase (BTK) inhibitor, Brukinsa (zanubrutinib), and acalabrutinib in terms of efficacy. The comparison is based on data from the Phase III ALPINE and Phase III ASCEND studies, which…
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Haihe Pharmaceuticals Licenses Glumetinib to Taiho for Exclusive Development in Japan and Asia
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Shanghai Haihe Pharmaceutical Co., Ltd has entered into a licensing agreement with Taiho Pharmaceutical Co., Ltd, granting the Japanese company exclusive rights to develop, manufacture, and commercialize glumetinib, a MET-targeted tyrosine kinase inhibitor (TKI), in Japan and other Asian countries (excluding China) and Oceania. Haihe has already submitted a market…
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Bayer’s BAY 2927088 Receives FDA Breakthrough Therapy Designation for HER2-Mutated NSCLC
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The US Food and Drug Administration (FDA) has granted Germany-based Bayer AG (ETR: BAYN) breakthrough therapy designation for its tyrosine kinase inhibitor (TKI) BAY 2927088. The drug is under review as a potential treatment for unresectable or metastatic non-small cell lung cancer (NSCLC) with activating HER2 (ERBB2) mutations that have…
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Healthstar Medical Commences Phase III Clinical Trial for KC1036 in Esophageal Cancer
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Healthstar Medical Development Co., Ltd (SHA: 603590), a Beijing-based pharmaceutical company, has announced the first patient dosing in a Phase III clinical study for its drug candidate KC1036, which is aimed at treating patients with advanced recurrent or metastatic esophageal squamous cell carcinoma (ESCC). This marks a significant milestone in…
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Inmagene Biopharmaceuticals Secures Exclusive License for HutchMed’s Drug Candidates IMG-007 and IMG-004
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HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) has announced that Sino-US biotech Inmagene Biopharmaceuticals has exercised its option to license two drug candidates discovered by HutchMed, IMG-007 and IMG-004, under the terms of a strategic partnership signed on January 11, 2021. Upon the exercise of these options and subject to…
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Johnson & Johnson’s Rybrevant and Lazertinib Filings Accepted for Review by CDE
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The Center for Drug Evaluation (CDE) has confirmed that Johnson & Johnson’s (J&J, NYSE: JNJ) market filings for Rybrevant (amivantamab) and lazertinib, designated as JXSS2400004 and JXHS2400009 respectively, have been accepted for review. Amivantamab-vmjw, a bispecific antibody targeting EGFR and MET, received its initial approval in May 2021 for the…
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Roche’s Tecentriq in Combination with Exelixis’s Cabometyx Meets Primary Endpoint in mCRPC Phase III Study
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Roche (SWX: ROG), the Swiss pharmaceutical giant, has announced positive results from a Phase III study showcasing the efficacy of its anti-PD-L1 drug Tecentriq (atezolizumab) in combination with Exelixis’s (NASDAQ: EXEL) tyrosine kinase inhibitor (TKI) Cabometyx (cabozantinib) for the treatment of metastatic castration-resistant prostate cancer (mCRPC). The study focused on…
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Qilu Pharmaceutical’s Iruplinalkib Gains Additional Indication Approval in China for ALK-Positive NSCLC
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The National Medical Products Administration (NMPA) website has indicated that Qilu Pharmaceutical’s Category 1 drug, Iruplinalkib, has received additional indication approval in China. The new indication is for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). Previously approved in China…
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Allist Pharmaceuticals’ Furmonertinib and AstraZeneca’s Enhertu Earn Breakthrough Designations in China for NSCLC Treatments
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The Center for Drug Evaluation (CDE) in China has indicated on its website that Allist Pharmaceuticals Co., Ltd, a Shanghai-based biotech firm, has received breakthrough therapy designations (BTDs) for its epidermal growth factor receptor (EGFR) tyrosine-kinase inhibitor (TKI) furmonertinib and for Enhertu (trastuzumab deruxtecan), a HER2-targeted antibody drug conjugate (ADC)…
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CSBIO’s Multi-Kinase Inhibitor CSCJC3456 Gets Green Light for Clinical Trials in Advanced Solid Tumors
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Hebei Changshan Biochemical Pharmaceutical Co., Ltd (CSBIO; SHE: 300255), a Chinese pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its small-molecule multi-kinase inhibitor, CSCJC3456. This molecule is now set to be evaluated in the context of general advanced malignant…
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Beijing Avistone Pharmaceuticals Raises RMB 1 Billion in Series B Funding to Accelerate Drug Development
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Beijing Avistone Pharmaceuticals Biotechnology Co., Ltd, based in China, has successfully closed its Series B funding round, raising RMB 1 billion (approximately USD 140 million). The round was jointly led by CS Capital and IDG Capital, with additional contributions from YanChuang Group, Cathay Capital, and existing investor Bain Capital. The…
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Healthstar Medical Receives NMPA Go-Ahead for KC1036 Esophageal Cancer Study
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Beijing-based Healthstar Medical Development Co., Ltd (SHA: 603590) has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for KC1036 in combination with a programmed-death 1 (PD-1) inhibitor as first-line maintenance therapy for patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC). KC1036,…
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CStone Pharmaceuticals Disbands Sales Team for Gavreto After NRDL Setback
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CStone Pharmaceuticals (HKG: 2616) has confirmed media reports regarding the dismissal of its sales team for Gavreto (pralsetinib), marking a significant shift in the Chinese company’s commercial strategy for its first product to reach the market. Gavreto, which was licensed to Allist Pharmaceuticals Co., Ltd in November 2023, did not…
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Sino Biopharmaceutical Completes Enrollment for Phase III Trial of Anlotinib in Soft Tissue Sarcoma
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Sino Biopharmaceutical Ltd (HKG: 1177), a China-based pharmaceutical giant, has announced the completion of patient enrollment for a Phase III clinical trial of anlotinib, marketed under the trade name FOCUS V, in conjunction with chemotherapy for first-line treatment of advanced soft tissue sarcoma. The trial, conducted by Jiangsu Chia Tai…
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Healthstar Medical Gets NMPA Approval for KC1036 Clinical Study in Juventus sarcoma
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Beijing-based Healthstar Medical Development Co., Ltd (SHA: 603590) has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its drug candidate KC1036 in advanced Juventus sarcoma for adolescents aged 12 and above. KC1036, a tyrosine kinase inhibitor (TKI) that targets AXL, VEGFR2, and FLT3,…
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MSD’s Welireg Gains FDA Approval for Advanced Renal Cell Carcinoma
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The US Food and Drug Administration (FDA) has granted an indication extension approval for Merck, Sharp & Dohme’s (MSD; NYSE: MRK) oral drug Welireg (belzutifan), expanding its use as a therapy for advanced renal cell carcinoma (RCC) in adults who have previously received a PD-1/L1 inhibitor and a VEGF tyrosine…
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Eli Lilly Seeks Approval for Pirtobrutinib in China for Relapsed Mantle Cell Lymphoma
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Eli Lilly (NYSE: LLY) has submitted a marketing approval application for pirtobrutinib, an oral, non-covalent (reversible) Bruton tyrosine kinase (BTK) inhibitor, according to the China Center for Drug Evaluation (CDE) website. The application targets adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have previously undergone BTK inhibitor…
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Healthstar Medical Launches Phase III Study for KC1036 in Advanced Esophageal Cancer
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Healthstar Medical Development Co., Ltd (SHA: 603590), based in Beijing, has received approval from China’s Center for Drug Evaluation (CDE) to commence a Phase III clinical study for its investigational drug candidate, KC1036. This randomized, controlled, open-label, multi-center Phase III trial aims to evaluate the efficacy and safety of KC1036…
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AnHeart Therapeutics and Innovent Biologics File Taletrectinib for Marketing Approval in China
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China’s Center for Drug Evaluation (CDE) has indicated on its website that taletrectinib, an ROS1/NTRK inhibitor co-developed by AnHeart Therapeutics and Innovent Biologics Inc. (HKG: 1801), has been filed for marketing approval. The drug is intended to treat ROS1 fusion positive non-small cell lung cancer (NSCLC) in patients who have…
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BeiGene Ltd Strikes Exclusive Global License Deal with Ensem Therapeutics for CDK2 Inhibitor
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China-based biopharmaceutical company BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced a licensing agreement with Ensem Therapeutics Inc., a biopharma company incubated by CBC Group and operating in Massachusetts, US, and Shanghai, China. According to the agreement, BeiGene will obtain an exclusive global license to Ensem’s oral cyclin-dependent…
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BeiGene’s Brukinsa Secures Additional EU Approval for Follicular Lymphoma Treatment
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BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has achieved its latest global approval for the Bruton’s tyrosine kinase (BTK) inhibitor, Brukinsa (zanubrutinib). The European Commission has approved Brukinsa in combination with obinutuzumab (Roche’s CD20-targeted Gazyva) as a third-line treatment for relapsed or refractory (R/R) follicular lymphoma (FL). This marks…
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Ascentage Pharma Secures Additional Indication Approval for Olverembatinib from NMPA
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China-based Ascentage Pharma (HKG: 6855) has announced receiving another indication approval from the National Medical Products Administration (NMPA) for its Category 1 drug, olverembatinib. This second market-approved indication is for the treatment of adult patients with chronic myeloid leukemia (CML) in the chronic phase (CP) who are resistant and/or intolerant…
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Beijing Aosaikang’s Combo Therapy for NSCLC Accepted for Clinical Trial by NMPA
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Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755), a Chinese pharmaceutical company, has announced that the China National Medical Products Administration (NMPA) has accepted a clinical trial application for the combination of two pipeline candidates, ASKC202 tablets and ASK120067 tablets. The company is seeking to evaluate this combination therapy in adults…
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US FDA Approves HutchMed and Takeda’s Fruzaqla for Metastatic Colorectal Cancer Treatment
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The US Food and Drug Administration (FDA) has granted approval to HutchMed (NASDAQ: HCM) and its partner Takeda (NYSE: TAK, TYO: 4502) for their oral tyrosine kinase inhibitor Fruzaqla (fruquintinib), marking the second approval this year for a China-developed innovative drug. The drug is indicated for adult patients with previously…
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Ascentage Pharma’s Olverembatinib Showcases Promising Results at ASH Annual Meeting
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Suzhou-based Ascentage Pharma (HKG: 6855) has presented the latest results of multiple studies regarding its innovative drug candidate olverembatinib at the 65th American Society of Hematology (ASH) annual meeting. The data highlights the potential of olverembatinib in treating various hematological malignancies, including chronic myeloid leukemia (CML) and Philadelphia-positive acute lymphoblastic…
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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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Zhejiang Jianfeng Receives FDA Approval for JFAN-1001 Clinical Trial in NSCLC
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Zhejiang Jianfeng Group Co., Ltd (SHA: 600668), a leading pharmaceutical company based in China, has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its Category 1 chemical drug, JFAN-1001. The drug is indicated for the treatment of locally advanced or metastatic…
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Dizal’s Sunvozertinib Shows Promising Efficacy in Advanced NSCLC at ESMO 2023
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) presented compelling efficacy and safety data for its next-generation epidermal growth factor receptor (EGFR) inhibitor, sunvozertinib, at the European Society for Medical Oncology (ESMO) Congress 2023. The drug is being evaluated for first-line treatment in advanced non-small cell lung cancer (NSCLC) with EGFR…
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BeiGene’s Brukinsa Gains NICE Recommendation for CLL Treatment in the UK
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China-based biotech BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced that the National Institute for Health and Care Excellence (NICE) in the UK has issued a final draft guidance (FDG) recommending the company’s Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib) for the treatment of eligible adult patients with…
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CDE Grants Priority Review to Pearl Biotech’s Breatinib for Glioblastoma Treatment
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China’s Center for Drug Evaluation (CDE) has indicated that Beijing Pearl Biotechnology Co., Ltd’s breatinib has obtained priority review status for the treatment of WHO grade 4 astrocytoma with isocitrate dehydrogenase (IDH) mutation and PTPRZ1-MET (ZM) fusion gene, or adult glioblastoma (GBM) patients who have relapsed after, or become intolerant…
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Betta Pharmaceuticals Secures NMPA Approval for Befotertinib in NSCLC Treatment
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China-based Betta Pharmaceuticals Co., Ltd. (SHE: 300558) has officially announced its receipt of market approval from the National Medical Products Administration (NMPA) for befotertinib, a third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI). This critical approval allows befotertinib to be used as a first-line treatment for locally advanced or…
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HutchMed and Takeda Submit Fruquintinib NDA for Metastatic CRC in Japan
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China-based HutchMed (HKG: 0013, NASDAQ: HCM) has announced that its partner Takeda (TYO: 4502) has submitted a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare (MHLW) in Japan for the approval of fruquintinib as a treatment for adult patients with previously treated metastatic colorectal cancer (CRC).…
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Jiangsu Hengrui Licenses Pyrotinib to Dr. Reddy’s for Indian Market
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has entered into a licensing agreement with India-headquartered Dr. Reddy’s Laboratories, granting the latter exclusive development and commercialization rights for its HER1/HER2/HER4 inhibitor, pyrotinib, in India. Financial Terms of the Agreement Under the terms of the agreement, Hengrui will receive an upfront…
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Abbisko Therapeutics Gets NMPA Approval for Irpagratinib Combination Study in HCC
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Shanghai-based biotechnology company Abbisko Therapeutics Co., Ltd (HKG: 2256) has received approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study for its pipeline candidate irpagratinib (ABSK121) in combination with lenvatinib for the treatment of advanced or irresectable hepatocellular carcinoma (HCC). This development marks a…
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Dizal Pharmaceutical’s Golidocitinib NDA Accepted for Review by NMPA
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has announced that the National Medical Products Administration (NMPA) has accepted for review its New Drug Application (NDA) for golidocitinib, a first-in-class JAK1 inhibitor. The drug candidate is filed for the initial indication of treating recurrent refractory peripheral T-cell lymphoma (r/r PTCL). Supporting…
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Menarini Group Secures Exclusive License for Astellas’ Smyraf in Taiwan
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A. Menarini Asia-Pacific Holdings Pte. Ltd, a subsidiary of the Italy-based Menarini Group, has entered into a long-term exclusive licensing agreement with Japan-headquartered Astellas Pharma Inc (TYO: 4503). The partnership grants Menarini the rights to develop, manufacture, and commercialize the orally administered Janus kinase (JAK) inhibitor Smyraf (peficitinib hydrobromide) in…
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InnoCare Pharma and ArriVent Biopharma Partner on Clinical Study for Advanced NSCLC Treatment
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China-based InnoCare Pharma (HKG: 9969; SHA: 688428) has announced that it has received the green light to conduct a clinical study in China for its drug candidate ICP-189, in combination with ArriVent Biopharma Inc.’s furmonertinib, for the treatment of advanced non-small cell lung cancer (NSCLC). The collaboration between InnoCare and…
