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Zhejiang Huahai’s HB0034 Meets Primary Endpoint in GPP Study
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China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) announced that its multi-center, double-blinded, randomized, placebo-parallel controlled pivotal study for HB0034, a Category 1 biologic product for acute generalized pustular psoriasis (GPP), has achieved the primary efficacy endpoint and all secondary efficacy endpoints. Study ResultsGPP is a rare, life-threatening, systemic neutropenic…
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Zhejiang Huahai Pharma’s HB0056 Receives NMPA Approval for Asthma Trials
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China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) announced that its bispecific antibody HB0056 has received clinical trial approval from China’s National Medical Products Administration (NMPA) for asthma. The approval follows similar clearances in New Zealand (October 2024) and the U.S. (January 2025), positioning the drug for global development. Clinical…
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Huahai Pharma Set to Launch IL-17 Antibody HB0017 Clinical Study for HS
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China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) is poised to initiate a clinical study for its interleukin-17 (IL-17) monoclonal antibody (mAb) HB0017 in hidradenitis suppurativa (HS) after receiving approval from the National Medical Products Administration (NMPA). This marks a significant step forward in the development of novel treatments for…
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Zhejiang Huahai’s HB0056 Approved for US Phase I Asthma Trial
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China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) has announced receiving clinical trial approval from the US Food and Drug Administration (FDA) for its HB0056. This injectable bispecific antibody (BsAb) targets thymic stromal lymphopoietin (TSLP) and interleukin-11 (IL-11) and is now cleared to enter Phase I clinical study in asthma.…
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Huahai Pharmaceutical to Transfer Rights to Innovative Antidepressant HHT001 via Public Listing
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China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) is set to transfer the patent and other rights to its hypidone (HHT001), an innovative antidepressant co-developed by the Academy of Military Medical Sciences’ (AMMS) toxicity and drug institute. The transfer will be conducted through a public listing on the China Technology…
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Huahai Pharmaceutical’s HB0028 and HB002.1T Cleared for Clinical Study by NMPA
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China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) has announced that it has received clearance from the National Medical Products Administration (NMPA) for its investigational drugs HB0028 and HB002.1T. The drugs are set to enter clinical studies, either in combination with or without standard chemotherapy, for the treatment of advanced…
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Zhejiang Huahai Pharmaceutical’s Subsidiary Huaota Bio Secures $27.4 Million Investment
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Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) has announced that its macromolecular drug-focused subsidiary, Shanghai Huaota Biopharmaceutical Co., Ltd., has successfully raised RMB 200 million (USD 27.4 million) through a new issuance of 20 million shares. The shares were exclusively subscribed by Linhai Haijing Venture Capital. This transaction has increased…
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Huahai Pharmaceutical’s Adalimumab Biosimilar Accepted by China’s CDE for Review
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On December 14th, the China National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE) announced that it has accepted the market application for Zhejiang Huahai Pharmaceutical Co., Ltd’s (SHA: 600521) adalimumab biosimilar injection. Adalimumab is a fully human anti-tumor necrosis factor-alpha (TNF-α) monoclonal antibody. The Role of TNF-α in…
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Zhejiang Huahai Pharmaceutical Initiates Clinical Study for HB0056 in New Zealand
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Zhejiang Huahai Pharmaceutical Co., Ltd. (SHA: 600521), through its subsidiary Shanghai Huaota Biopharmaceutical Co., Ltd., has announced the first subject dosing in a clinical study for its potential first-in-class drug, HB0056, in New Zealand. This marks a significant step forward in the development of this innovative therapy. HB0056: A Bispecific…
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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…
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Zhejiang Huahai Pharmaceutical Receives FDA Approval for Generic Vyvanse
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Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521), a China-based pharmaceutical company, has announced the receipt of Abbreviated New Drug Application (ANDA) approval from the US FDA for its generic version of Japan firm Takeda’s (TYO: 4502) Vyvanse (lisdexamfetamine). Vyvanse is a medication used to treat attention-deficit hyperactivity disorder (ADHD). Lisdexamfetamine’s…
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Huahai Pharma’s HB0025 Receives NMPA Approval for Clinical Trials
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China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for HB0025, an in-house developed bispecific antibody (BsAb) targeting programmed-death ligand 1 (PD-L1) and vascular endothelial growth factor (VEGF). The BsAb will be assessed in combination…
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Huahai Pharma Raises Funds for Digital Manufacturing and API Platform
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China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) plans to raise RMB 1.56 billion (USD 226.2 million) through the private placement of 148 million shares on the Shanghai Stock Exchange. The proceeds will be directed towards the preparation of a digital intelligent manufacturing construction project and an anti-viral active pharmaceutical…
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Junshi Biosciences’ COVID-19 Therapy Faces Supply Issues, Partners with Sihuan Pharma
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Junshi Biosciences’ (HKG: 1877, SHA: 688180) COVID-19 therapy JT001 (VV116) appears to be facing supply issues, prompting the company to seek additional production and supply agreements. The latest deal was struck with Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460), following a similar agreement with Zhejiang Huahai Pharmaceutical Co., Ltd (SHA:…
