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Boan Biopharma’s BA1302 receives FDA approval for clinical trials

On June 17, Boan Bio (06955) issued an announcement, announcing that its independently developed innovative antibody-drug conjugate BA1302 targeting CD228 has been approved by the U.S. Food and Drug Administration (FDA) to conduct clinical trials. 　　The drug is intended for the treatment of a variety of solid tumors and has been granted orphan drug designation by the FDA for squamous non-small cell lung cancer and pancreatic cancer. Currently, BA1302 is undergoing Phase 1 clinical trials in China, and its global progress is ahead of other similar research and development efforts. 　　BA1302 has shown excellent internalization activity and bystander effects in preclinical studies, and can effectively inhibit the growth of tumor models derived from various cancer patients, showing good therapeutic potential. In addition, compared with the marketed ADCs with MMAE as toxin, BA1302 has shown a longer half-life and better safety in crab-eating monkeys. The company will ...
- Source: drugdu
- 85
- June 18, 2025
First patients enrolled in Phase I clinical trial of Clover Biopharmaceuticals combination vaccine

On June 17, Clover Biopharmaceuticals (02197) issued an announcement announcing that its respiratory syncytial virus (RSV) + human metapneumovirus (hMPV) ± parainfluenzaThe Phase I clinical trial of the PIV3 combined vaccine candidate product has completed the enrollment of the first batch of subjects. 　　The vaccine candidates involved in this trial include SCB-1022 (RSV+hMPV) and SCB-1033 (RSV+hMPV+PIV3), which are developed based on the company’s protein trimerization vaccine technology platform. 　　According to the announcement, the Phase I clinical trial results of Clover Biopharmaceuticals’ RSVPreF vaccine candidate product (SCB-1019) announced in October 2024 showed that the vaccine had potentially best-in-class immunogenicity and tolerability characteristics in 70 elderly subjects. 　　This clinical result provides support for the company’s subsequent joint development of hMPV and PIV3 vaccines. The current Phase I clinical trial of the combined vaccine candidate product will enroll up to 192 elderly subjects to evaluate its safety, reactogenicity and ...
- Source: drugdu
- 82
- June 18, 2025
When China’s innovative drugs enter a golden age

Amid the wave of changes in the global pharmaceutical industry, BD transactions are becoming a key engine for Chinese innovative pharmaceutical companies to break through. In 2025, BD transactions in the field of innovative drugs will show explosive growth. A deep game about technology, capital and market is unfolding, and Chinese innovative pharmaceutical companies are standing at the forefront of this change with their outstanding performance. The heat storm behind the data According to incomplete statistics, in May 2025 alone, at least six domestic innovative pharmaceutical companies officially announced BD transaction orders, and most of them were cross-border cooperation between Chinese and foreign pharmaceutical companies. This high frequency of transactions is not accidental, but a microcosm of the hot trend of innovative drug BD transactions in 2025. Data shows that from the beginning of 2025 to date, the total transaction amount of innovative drugs going overseas has reached US$45.5 billion, ...
- Source: drugdu
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- June 18, 2025
The value of this CAR-T therapy is still increasing

In February 2024, AstraZeneca officially incorporated Gracell into the group, setting a precedent for MNCs to acquire Chinese biotechs on a large scale. Gracell is AstraZeneca’s first acquisition in the CAR-T track, with its outstanding technology and pipeline – FasTCAR and AZD0120 at its core. AZD0120 is a BCMA/CD19 dual-targeted CAR-T cell therapy developed based on the FasTCAR rapid production platform, which has the potential to become a new generation of treatment options for malignant blood tumors and autoimmune diseases. As one of the core pipelines in AstraZeneca’s cell therapy matrix, the development strategy and clinical progress of AZD0120 have attracted much attention. The field of autoimmunity has been “tempered and upgraded”, and its value continues to increase At the EULAR 2025 Annual Meeting, Gracell Biopharma announced for the first time the safety and preliminary efficacy data of the IIT study of AZD0120 for the treatment of refractory systemic lupus ...
- Source: drugdu
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- June 18, 2025
【EXPERT Q&A】How to register a drug with the DMF in the United States?

Drugdu.com expert’s response: The registration of a Drug Master File (DMF) for pharmaceuticals in the United States is a complex process involving multiple steps and requirements. Below are the main procedures and key points for registration: I. Determine the DMF Type Select the appropriate DMF type based on the product characteristics. Common types include: Type II: Manufacturing and control information for Active Pharmaceutical Ingredients (APIs) and intermediates, which is the most common type. Type III: Packaging materials. Type IV: Excipients. Type V: Information specifically requested by the FDA. II. Prepare Required Documents Cover Letter: Introduce the content and purpose of the DMF, including the DMF type. DMF Holder Information: Company name, address, contact person, etc. Letter of Authorization (LOA): If another company will reference this DMF, provide an LOA. Manufacturing Process Description: Detailed description of the production process and key process parameters. Quality Standards: Include specifications, impurities, and physicochemical properties, ...
- Source: drugdu
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- June 18, 2025
New insights into gout management strategies and cardiovascular outcomes

The European Alliance of Associations for Rheumatology – recommends that serum urate should be maintained at <6 mg/dL (360 µmol/L) and <5 mg/dL (300 µmol/L) in those with severe gout. But despite available treatments, gout is still often underdiagnosed and its management remains suboptimal. At the 2025 annual EULAR congress in Barcelona, new data were presented on a range of topics around gout. Gout flares are associated with cardiovascular events. Treating gout to target serum urate level prevents flares, but whether such treatment can also prevent cardiovascular events is unknown. An abstract from Edoardo Cipolletta and colleagues explored whether achieving serum urate levels of less than 360 μmol/L within 1 year of the first prescription of urate-lowering therapy has an effect on the 5-year risk of major adverse cardiovascular events (MACE). The authors used English and Swedish primary-care data linked to hospitalisation and mortality records for over 116,000 patients. Overall, ...
- Source: drugdu
- 95
- June 17, 2025
How Technology can Ease the Path to New Treatments Without the Pain

|Advances in flow cytometry could enable researchers to uncover valuable insights about food allergies without allergen exposure.Food allergies affect an estimated 220 million people(Opens in a new window) around the world, the World Health Organization reports. In the United States alone, one in 13 children are living with life-threatening food allergies, according to the non-profit organization Food Allergy Research and Education (FARE(Opens in a new window)). A major milestone in this field was reached in 2024 when the U.S. Food and Drug Administration approved the first biologic to treat food allergies after accidental exposures, Xolair (omalizumab). While there are a handful of other food-allergy treatments in the development pipeline, including combinations of monoclonal antibodies and immune-boosting drugs, innovation in this field remains limited. Replacing dated and harmful methods One limitation holding back the development of new therapies for food allergies is that many commonly used research tools are outdated and ...
- Source: drugdu
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- June 17, 2025
Da Canlin’s performance briefing signals that the store network has been basically completed and will focus on the development of regional encryption and refinement

Recently, the leading player in the pharmaceutical retail industry, Dachanlin (603233. SH), held a performance briefing for 2024 and the first quarter of 2025, showcasing the company’s operating results and future development plans in all aspects. Peng Guangzhi, the Chief Financial Officer and Secretary of the Board of Directors of the company, pointed out that Da Canlin has successfully built a store network covering 21 provinces (autonomous regions, municipalities directly under the central government) across the country, and the cross provincial expansion battle has been basically completed. In 2025, the company will focus on accelerating the increase of market share in areas already covered by encryption and further strengthen economies of scale. In 2024, Da Canlin submitted a remarkable report card. In 2024, the company achieved a revenue of approximately 26.497 billion yuan, a net profit attributable to shareholders of the listed company of approximately 915 million yuan, a net ...
- Source: drugdu
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- June 17, 2025
The new drug application for ADHD has been accepted and included in the priority review! Aike Baifa Declaration

Today (June 16th), Shanghai Aike Baifa Biopharmaceutical Technology Co., Ltd. (hereinafter referred to as “Aike Baifa”) announced that its new drug Aizhida (generic name: Sildenafil/Dexmedetomidine Compound Capsules; code: AK0901) has been officially accepted by the Drug Evaluation Center (CDE) of the National Medical Products Administration (NMPA) of China, and has been included in the “priority review and approval” procedure. The proposed indication is the treatment of attention deficit hyperactivity disorder (ADHD) patients aged 6 years and above. Attention Deficit Hyperactivity Disorder (ADHD), commonly known as ADHD, is a chronic brain disease characterized by difficulty concentrating, hyperactivity, and impulsivity. ADHD symptoms may begin to appear in children between the ages of 3-6 and can persist into adolescence and adulthood. ADHD is the most common mental illness in childhood, affecting 8% to 9% of school-age children. Methylpheniramate has been recommended as a first-line treatment option for children and adults with ADHD in ...
- Source: drugdu
- 64
- June 17, 2025
Heyu Pharmaceuticals Completes Dosing of the First Patient in the Registrational Clinical Trial of Ipagotinib for the Treatment of HCC

Heyu announced on the Hong Kong Stock Exchange that its subsidiary Shanghai Heyu Biopharmaceutical Technology Co., Ltd. (“Heyu Pharmaceutical”) has completed the first patient dosing in the registration clinical trial of its independently developed highly selective small molecule FGFR4 inhibitor ipagotinib for the treatment of hepatocellular carcinoma (HCC). Ipagotinib was recognized as a breakthrough therapy by the Drug Evaluation Center of the China National Medical Products Administration in May 2025. Ipagotinib is also the first drug to use targeted molecular biomarkers to precisely treat HCC. https://finance.eastmoney.com/a/202506163430938887.html
- Source: drugdu
- 61
- June 17, 2025

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