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Hainan Poly Pharm’s Novel Nanomedicine PLAT001 Cleared for Clinical Trial by NMPA
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Hainan Poly Pharm Co., Ltd (SHE: 300630), a Chinese pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its innovative drug candidate, PLAT001. This novel injectable drug is under evaluation for the treatment of general advanced or metastatic solid tumors.…
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Hainan Poly Pharm’s Manufacturing Units Get GMP Nod From Saudi Food and Drug Authority
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Hainan Poly Pharm Co., Ltd (SHE: 300630), a Chinese pharmaceutical company, announced that it has received a GMP certificate from the Saudi Food and Drug Authority (SFDA). The GMP certification covers seven pharmaceutical varieties registered in Saudi Arabia, including eptifibatide, nitroprusside, folinic acid, ganciclovir, azithromycin, cyclophosphamide, and levetiracetam. A total…
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Hainan Poly Pharm Secures Tentative FDA Approval for Generic Version of UCB’s Briviact
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Hainan Poly Pharm Co., Ltd (SHE: 300630), a Chinese pharmaceutical company, has announced that it has received tentative marketing approval from the US Food and Drug Administration (FDA) for its generic version of Belgium-based UCB’s Briviact (brivaracetam). Briviact is recognized as a selective high-affinity synaptic vesicle protein 2A (SV2A) ligand,…
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Hainan Poly Pharm Wins FDA Nod for Generic Version of UCB’s Vimpat
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Hainan Poly Pharm Co., Ltd (SHE: 300630), a Chinese pharmaceutical company, has announced that it has received marketing approval from the US Food and Drug Administration for its generic version of UCB’s Vimpat (lacosamide), originally developed by the Belgium-headquartered UCB. The approved generic will be used for the treatment of…
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Hainan Poly Pharm’s Novel Nanomedicine PLAT001 Gets US FDA Approval for Clinical Trials
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Hainan Poly Pharm Co., Ltd (SHE: 300630), a Chinese pharmaceutical company, has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its novel injectable PLAT001, intended for the treatment of advanced or metastatic solid tumors, including pancreatic cancer. PLAT001, a groundbreaking nanomedicine,…
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Hainan Poly Pharm Receives FDA Approval for PL002 in Primary Liver Cancer Surgery
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China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) has announced that it has received clinical trial approval from the US FDA for its novel injection candidate PL002. This innovative product is indicated for preoperative diagnosis and intraoperative navigation in patients with primary liver cancer. PL002 is an in-house developed bimodal…
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Hainan Poly Pharm’s PL002 Accepted for FDA Review for Liver Cancer Surgery
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China-based pharmaceutical company Hainan Poly Pharm Co., Ltd (SHE: 300630) has announced that the Investigational New Drug (IND) filing for its novel injectable PL002 has been accepted for review by the US Food and Drug Administration (FDA). The drug is indicated for preoperative diagnosis and intraoperative navigation in patients with…
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Hainan Poly Pharm Submits DMF for Tecovirimat API to US FDA
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China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) has announced the filing of a Drug Master File (DMF) with the US Food and Drug Administration (FDA) for its tecovirimat active pharmaceutical ingredients (APIs). This move signifies the company’s initiative to bring a potential treatment for poxvirus infections, including smallpox and…
