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Zhejiang Huahai Pharmaceutical Gets New Zealand Approval for Asthma Bispecific Antibody Trial
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Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) has announced receiving clinical trial approval in New Zealand for its HB0056, a bispecific antibody (BsAb) targeting thymic stromal lymphopoietin (TSLP) and interleukin-11 (IL-11), clearing the way for the drug to enter Phase I clinical studies for asthma treatment. HB0056 is the world’s…
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Huahai Pharmaceutical Gets FDA Nod for Generic Empagliflozin and Metformin ANDA
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Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521), a prominent Chinese pharmaceutical company, has announced the receipt of Abbreviated New Drug Application (ANDA) approval from the US Food and Drug Administration (FDA) for its generic version of Boehringer Ingelheim’s (BI) empagliflozin and metformin combination therapy. This therapy was originally approved in…
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Zhejiang Huahai Pharmaceutical Co., Ltd Plans Capital Raise for Digital Manufacturing Expansion
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Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521), a leading Chinese pharmaceutical company, has unveiled plans for a private placement of 148,000,000 shares, raising a total of RMB 1.21 billion (approximately USD 170 million). The capital raised from this private placement is earmarked for the construction of digital intelligent manufacturing facilities…
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Zhejiang Huahai Pharmaceutical Wins IND Approval for Antibody-Drug Conjugate from China’s NMPA
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Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521), a China-based pharmaceutical company, has announced that it has received Investigational New Drug (IND) approval from the National Medical Products Administration (NMPA) for its innovative injectable drug candidate, HB0052. The drug is initially intended for evaluation in patients with general advanced solid tumors.…
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AstraZeneca Advances to Phase III with PD-1xTIGIT BsAb for Biliary Tract Cancer
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AstraZeneca (AZ; NASDAQ: AZN), a UK-based pharmaceutical company, is set to initiate a Phase III study for its PD-1xTIGIT bispecific antibody (BsAb) rilvegostomig in combination with chemotherapy for patients with biliary tract cancer (BTC) following surgical resection. The double-blind, placebo-controlled, global trial aims to assess the efficacy and tolerability of…
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Zhejiang Huahai Pharmaceutical’s HB0052 Receives US FDA IND Approval for Solid Tumors
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IntroductionZhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521), a China-based pharmaceutical company, has announced that it has received Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) for its injectable drug candidate, HB0052. The drug will initially be assessed in general advanced solid tumors, marking a significant…
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Zhejiang Huahai Pharmaceutical Secures Orphan Drug Designation for HB0034
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China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) has announced that it has received orphan drug designation (ODD) from the US FDA for its interleukin-36 receptor monoclonal antibody (mAb) HB0034. This designation highlights the drug’s potential as a treatment for generalized pustular psoriasis (GPP). Mechanism of Action and Broader Implications…
