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UK pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) has announced a strategic partnership with Cellectis (EPA: ALCLS; NASDAQ: CLLS) to develop next-generation therapeutics, focusing on areas of high unmet need such as oncology, immunology, and rare diseases. This collaboration aims to leverage Cellectis’s gene editing technologies and manufacturing capabilities to advance…
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Japan’s Daiichi Sankyo (TYO: 4568) reported a robust 19.5% year-on-year (YOY) increase in revenue for the six months ended September 30, 2023, reaching JPY 726.3 billion (USD 4.8 billion), according to the company’s financial report published this week. This growth was driven by a combination of factors, including the depreciation…
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The China’s Center for Drug Evaluation (CDE) website has indicated that Chongqing Precision Biotechnology Co., Ltd’s PCAR-19B cell autologous reinfusion preparation is on track to receive breakthrough therapy designation (BTD). This designation recognizes the potential of PCAR-19B as a treatment for patients aged 3 to 21 years old with CD19-positive…
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The China’s Center for Drug Evaluation (CDE) website has indicated that Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd’s (HKG: 6990) drug candidate, SKB264, is on track to obtain priority review status for the treatment of unresectable, locally advanced, or metastatic triple negative breast cancer (TNBC) in China. This development is particularly significant…
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China-based biopharmaceutical company Hinova Pharmaceuticals (SHA: 688302) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) in China for its drug candidate HP518, which is being developed to treat metastatic castration-resistant prostate cancer (mCRPC). The androgen receptor (AR)-targeted PROteolysis TArgeting Chimera (PROTAC) drug…
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China-based 3SBio Inc., (HKG: 1530) has announced a strategic partnership and exclusive licensing agreement with compatriot firm CStone Pharmaceuticals (HKG: 2616), focusing on CStone’s anti-programmed death-1 (PD-1) antibody, nofazinlimab. This partnership signifies a significant expansion in the immuno-oncology space for both companies. Financial Terms and Agreement DetailsUnder the terms of…
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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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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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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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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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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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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 (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 (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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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 (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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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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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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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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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.…