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Hainan Poly Pharm Faces Delisting After CSRC Imposes Strict Penalties for Financial Misconduct
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China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) was imposed strict administrative penalties by the China Securities Regulatory Commission (CSRC) last week. This action has triggered a delisting process by the Shenzhen Stock Exchange. The penalties were imposed after significant false records were discovered in Poly Pharm’s 2021 and 2022…
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Hainan Poly Pharm’s US Partner Slate Run Pharmaceuticals Collaborates with Premier on Contrast Agents
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China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) announced a significant partnership between its US partner Slate Run Pharmaceuticals and Premier, Inc. (NASDAQ: PINC), a healthcare-focused group purchasing organization (GPO) in the US. The collaboration centers on contrast agents. Partnership DetailsUnder the agreement, Premier’s members have the freedom to purchase…
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Hainan Poly Pharm’s Generic ProHance Wins FDA Approval in US
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China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) announced that the US Food and Drug Administration (FDA) has approved its generic version of Bracco’s ProHance (gadoteridol), making it the first and currently only ProHance generic available in the US. The approved strengths include 1.3965 g/5 mL, 2.793 g/10 mL, 4.1895…
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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…
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Hainan Poly Pharm Wins Health Canada Approval for Generic Cytovene-IV (Ganciclovir)
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Hainan Poly Pharm Co., Ltd (SHE: 300630), a China-based pharmaceutical company, has announced that it has received marketing approval from Health Canada for its generic version of Roche’s Cytovene-IV (ganciclovir). This development marks a significant step for the company as it expands its international footprint in the generic drugs market.…
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Hainan Poly Pharm’s Generic Gadovist Receives FDA Approval for MRI Use
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China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) has announced that it has received marketing approval from the US FDA for its generic version of German giant Bayer’s (ETR: BAYN) Gadovist (gadobutrol injection). The drug is approved for use in contrast-enhanced magnetic resonance imaging (CE-MRI) examination of lesions in various…
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Hainan Poly Pharm’s Generic Ganciclovir Approved in Denmark
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China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) has announced receiving marketing approval from the health regulatory body in Denmark for its generic version of Roche’s Cytovene-IV (ganciclovir). This approval marks another milestone in the global expansion of Poly Pharm’s product portfolio, targeting the treatment of cytomegalovirus retinitis in immunocompromised…
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Hainan Poly Pharm Receives FDA Approval for Generic Lincomycin
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China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) has announced receiving marketing approval from the US FDA for its generic version of US-based Upjohn’s lincomycin. This approval marks a significant milestone for Poly Pharm in expanding its presence in the US market. Drug Profile and IndicationsLincomycin, first approved in the…
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Hainan Poly Pharm Wins Finland Approval for Generic Cytovene-IV
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China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) has announced receiving marketing approval from the Finland National Agency for Medicines for its generic version of Roche’s Cytovene-IV (ganciclovir). The approval marks a significant expansion of the company’s market presence in Europe. The targeted indications include the treatment of cytomegalovirus retinitis…
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Hainan Poly Pharm’s Generic Ganciclovir Approved in Sweden for CMV Retinitis
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China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) has announced receiving technical review approval from the Medical Products Agency of Sweden for its generic version of Roche’s Cytovene-IV (ganciclovir). The approval is for the treatment of cytomegalovirus (CMV) retinitis in immunocompromised patients, including those with AIDS, and for the prevention…
