PharmaFocus Today – Page 2 – media

Potential BIC! Amoytop Biotech Introduces New Drug for Chronic Hepatitis B

On April 16, Amoytop Bio announced that it had signed a Licensing Agreement with Aligos Therapeutics, Inc. According to the agreement, Amoytop Bio will obtain an exclusive, non-transferable intellectual property license from Aligos to develop, manufacture, and commercialize Pevifoscorvir sodium ( also known as ALG-000184) in the licensed territories (Mainland China, Hong Kong SAR, Macao SAR, and Taiwan) and in the licensed fields (treatment, prevention, or relief of human hepatitis B virus infection or human hepatitis B virus/hepatitis D virus co-infection) , and will have the right to sublicense as stipulated in the agreement. In return, Amoytop Biotech will pay Aligos an upfront payment of US$25 million upon the agreement’s effective date , and will also pay regulatory milestone fees (up to US$85 million ), sales milestone fees (up to US$335 million ), and royalties calculated as a single-digit percentage of net sales, based on the progress of clinical and ...
- Source: drugdu
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- April 17, 2026
Received $650 million RC148 down payment from AbbVie

On April 15th, Nanfang Finance News reported that Rongchang Biotechnology (09995.HK) issued a voluntary announcement stating that the company received a payment from AbbVie on April 15, 2026.The company has made an upfront payment of US$650 million for an exclusive licensing agreement for RC148. This agreement, effective March 10, 2026, grants AbbVie exclusive rights to develop, manufacture, and commercialize RC148 (the company’s proprietary PD-1/VEGF bispecific antibody drug) outside of Greater China. Under the agreement, the company is also entitled to up to US$4.95 billion in subsequent milestone payments, as well as tiered royalties from net sales outside of Greater China. This payment marks a significant step forward in the company’s international collaborations, will substantially enhance its cash reserves and R&D capabilities, and will facilitate faster global clinical development and pipeline value realization. https://finance.eastmoney.com/a/202604153706015296.html
- Source: drugdu
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- April 17, 2026
Maiweijian® (Denosumab Injection) New Indication Supplemental Application Accepted by NMPA

Maiwei Biopharmaceutical (688062.SH), an innovative biopharmaceutical company with a full-industry chain layout, announced that the National Medical Products Administration (NMPA) has accepted the supplemental application for adding indications for Maiweijian® (denosumab injection, R&D code: 9MW0321), independently developed by its wholly-owned subsidiary Taikang Biopharmaceutical , for the treatment of bone metastases of solid tumors and multiple myeloma (for the treatment of patients with bone metastases of solid tumors or multiple myeloma, to delay or reduce the risk of bone-related events (pathological fractures, spinal cord compression, bone radiotherapy or bone surgery)). Maiweijian® is the first denosumab biosimilar (120mg) approved for marketing in China . It was first approved in March 2024 for the treatment of giant cell tumors of bone that are unresectable or whose surgical resection would result in severe functional impairment, including adults and skeletally mature (defined as at least one mature long bone and a weight ≥45kg) adolescents. In ...
- Source: drugdu
- 64
- April 16, 2026
The first subject has been enrolled in the Phase II clinical trial in China for its innovative drug LY03017, which is used to treat Alzheimer’s disease and psychotic disorders.

Luye Pharma (02186.HK) issued a voluntary announcement stating that its independently developed innovative drug…The first subject has been enrolled in the Phase II clinical trial in China of LY03017 for the treatment of psychotic disorders in Alzheimer’s disease. LY03017 is a new-generation 5-HT2AR inverse agonist and 5-HT2CR antagonist, with target indications including psychotic disorders in Alzheimer’s disease, psychotic disorders in Parkinson’s disease, and negative symptoms of schizophrenia. This Phase II clinical trial is a randomized, double-blind, parallel, placebo-controlled study designed to evaluate the preliminary efficacy and safety of LY03017 in treating hallucinations and delusions associated with Alzheimer’s disease; the drug has previously been approved for clinical trials in the United States. Background: Of the approximately 57 million dementia patients worldwide, 60% to 70% have Alzheimer’s disease, of whom 25% to 50% experience psychotic symptoms. Currently, there are no approved drugs worldwide for this indication. The Phase I clinical trial of ...
- Source: drugdu
- 66
- April 16, 2026
The first subject has been enrolled in the Phase II clinical trial in China for its innovative drug LY03017, which is used to treat Alzheimer’s disease and psychotic disorders.

Nanfang Finance News, April 15th – Luye Pharma (02186.HK) issued a voluntary announcement stating that its independently developed innovative drug…The first subject has been enrolled in the Phase II clinical trial in China of LY03017 for the treatment of psychotic disorders in Alzheimer’s disease. LY03017 is a new-generation 5-HT2AR inverse agonist and 5-HT2CR antagonist, with target indications including psychotic disorders in Alzheimer’s disease, psychotic disorders in Parkinson’s disease, and negative symptoms of schizophrenia. This Phase II clinical trial is a randomized, double-blind, parallel, placebo-controlled study designed to evaluate the preliminary efficacy and safety of LY03017 in treating hallucinations and delusions associated with Alzheimer’s disease; the drug has previously been approved for clinical trials in the United States. Background: Of the approximately 57 million dementia patients worldwide, 60% to 70% have Alzheimer’s disease, of whom 25% to 50% experience psychotic symptoms. Currently, there are no approved drugs worldwide for this indication. ...
- Source: drugdu
- 59
- April 16, 2026
Its subsidiary’s Phase III clinical trial of “Vitamettrazil” has completed the enrollment of the first patient.

On April 15, China Biopharmaceutical (01177) issued an announcement stating that its wholly-owned subsidiary, Lixin Pharmaceutical Technology (Shanghai) Co., Ltd., has independently developed a Class 1 innovative drug.Vitacoltobayumab (development code: LM-302) is undergoing a Phase III registration clinical trial in combination with a PD-1 monoclonal antibody as first-line treatment for CLDN18.2-positive locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma, and the first patient has been successfully enrolled. LM-302 has been included in the Breakthrough Therapy Program by the China National Medical Products Administration for multiple indications and has received orphan drug designation from the U.S. Food and Drug Administration. https://finance.eastmoney.com/a/202604153705999476.html
- Source: drugdu
- 57
- April 16, 2026
A multi-billion dollar market is fiercely competitive, with Huadong Medicine applying for marketing approval of its megglutinin weight loss product.

On the evening of April 14, Huadong Medicine (000963) issued an announcement stating that its wholly-owned subsidiary, Hangzhou Sino-American Huadong Pharmaceutical Jiangdong Co., Ltd., received an “Acceptance Notice” issued by the National Medical Products Administration (NMPA) for the acceptance of its application for marketing authorization of Smegglutide injection, which is applicable to long-term weight management in adult patients based on diet control and increased physical activity. Previously, Huadong Medicine’s application for marketing authorization of its semaglutide injection for the hypoglycemic indication had been formally accepted by the National Medical Products Administration (NMPA). The acceptance of its application for the weight loss indication signifies that the product is poised to further expand its clinical application scenarios, meeting diverse market demands while gradually unlocking its long-term growth potential in chronic disease management and weight control. Smegglutide injection is a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist with 94% sequence homology to human GLP-1. ...
- Source: drugdu
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- April 16, 2026
Another domestically developed AD drug successfully completed Phase III trials.

Recently, Zaijing Pharmaceuticals announced that its independently developed Class 1 new drug, gecacitinib hydrochloride tablets (formerly known as jactinib hydrochloride tablets), has met its primary efficacy endpoint in a multicenter, randomized, double-blind, placebo-controlled phase 3 clinical trial for the treatment of moderate to severe atopic dermatitis in adult patients , demonstrating statistical significance (p<0.0001). This signifies another major breakthrough for Zaijing Pharmaceuticals in the field of autoimmune diseases. Gecacitinib is a novel dual inhibitor of JAK and ACVR1 independently developed by Zaijing Pharmaceuticals , and is classified as a Class 1 new drug. This drug received NMPA approval in May 2025 for the treatment of intermediate- and high-risk myelofibrosis, making it the first domestically produced innovative JAK inhibitor approved for the treatment of myelofibrosis. In addition, the NMPA has accepted the NMPA application for the indication of severe alopecia areata and is currently under review and approval; the three clinical ...
- Source: drugdu
- 52
- April 16, 2026
Henlius’s cetuximab biosimilar HLX05-N received approval in China for clinical trials.

On April 14, 2026, Henlius Biotech (2696.HK) announced that its Investigational New Drug (IND) application for HLX05-N (recombinant anti-EGFR human-mouse chimeric monoclonal antibody injection), a cetuximab biosimilar developed by the company, was approved by the National Medical Products Administration (NMPA) of China for the treatment of metastatic colorectal cancer. Epidermal growth factor receptor (EGFR) belongs to the ErbB family of cell surface erythroleukemia virus oncogene homologs with tyrosine kinase activity. It is a transmembrane glycoprotein widely expressed in normal epithelial cells and tumor tissues such as colorectal cancer and head and neck cancer. EGFR-mediated signaling pathways regulate tumor growth through multiple pathways and play a key regulatory role in the proliferation, differentiation, survival, and metastasis of tumor cells. Therefore, it is considered an important therapeutic target for related tumors. Cetuximab specifically binds to EGFR on the cell surface. On one hand, it competitively inhibits the binding of ligands such as ...
- Source: drugdu
- 61
- April 15, 2026
Huadong Medicine’s application for marketing authorization of megglutide injection for remanufactured fluids has been accepted by the NMPA.

On April 14, 2026, Hangzhou Sino-American Huadong Pharmaceutical Jiangdong Co., Ltd. (hereinafter referred to as “Jiangdong Company”), a wholly-owned subsidiary of Huadong Medicine Co., Ltd. (hereinafter referred to as “the Company”), received the “Acceptance Notice” issued by the National Medical Products Administration (NMPA), in which the marketing authorization application for Smegglutide injection (research code: HDM1702) submitted by Jiangdong Company was accepted. The indication for this application is: This product is suitable for long-term weight management in adult patients based on diet control and increased physical activity, with an initial body mass index (BMI) meeting the following criteria: ≥30kg/m2 ( obese), or ≥27kg/m2 to <30kg/m2 ( overweight) and having at least one weight-related comorbidity, such as hyperglycemia, hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease. Regarding Smegglutide injection Smegglutide injection is a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist with 94% sequence homology to human GLP-1. Clinically, it is mainly used for ...
- Source: drugdu
- 59
- April 15, 2026

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