Dandelion Bio·News | Biopharma Weekly Highlights (April 17–23, 2025)
Johnson & Johnson
Medical Device R&D and Manufacturer
Akeso
Innovative Antibody Drug Developer
Innovent
High-end Biologics Developer
'%20fill='%23FFFFFF'%3E%3Crect%20x='249'%20y='126'%20width='1'%20height='1'%3E%3C/rect%3E%3C/g%3E%3C/g%3E%3C/svg%3E)
Bio·News
Medicine
Supervision
Resources
News
1. ICH | Release of the "ICH Q1 Stability Guidelines"
22025On April 17, ICH released a fully revised draft of the Q1 Stability Guidelines for public consultation, marking an important step forward in the pharmaceutical industry's drug stability testing field. This draft consolidates the existing Q1A-F and Q5C guidelines, introducing new testing methods and topics aimed at enhancing the efficiency and flexibility of drug quality management through science and risk-based strategies.
(Source: ICH Official Website）
Affected
Principle
Situation
Condition
CDE Acceptance Status
April 17, 2025During the period from January to April 23, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of ChinaA total of 291 drug applications were acceptedIndividual, among which36 Biological Products（20 New Drugs andInOral 6）。
Enterprise
Industry
Move
State
1、Johnson & Johnson | FcRn Antibody New Drug Class 1 Submission for Market Approval in China
2025April 2Day 3,CDE official website announcement,Johnson & Johnson's New Drug Application for Nicallimab Injection, a Class 1 new drug, has been accepted. Public information indicates that Nicallimab (nipocalimab) is an antibody therapy targeting the neonatal Fc receptor (FcRn). The product has also been submitted to the U.S. FDA for marketing approval for the treatment of generalized myasthenia gravis (gMG), with a PDUFA date of April 29.
(Source: CDE Official WeChat, Pharmaceutical Observer)）
2、Belief BioMed | DMD Gene Therapy Approved for Clinical Trials in China
2025April 18，CDE Official Website Announcement: Belief BioMed's Investigational New Drug BBM-D101 Injection Approved for Clinical Trials, Intended for Treating Duchenne Muscular Dystrophy (DMD). Public data indicates that this is an Adeno-Associated Virus (AAV) gene therapy drug. This marks the first time the product has received IND approval in China.
(Source：Merck China Official WeChat）
3Akeso | "Dual-Target" New Drug Approved for Marketing
22025On April 18, Akeso announced,The independently developed Erobiximab Injection (brand name: Aidaro) has been approved for marketing by the National Medical Products Administration., indicated for the treatment of adult patients with moderate to severe plaque psoriasis who have had an inadequate response to, have a contraindication to, or are intolerant to other systemic therapies such as cyclosporine and methotrexate (MTX) or PUVA (psoralen and ultraviolet A).
(Source: Akeso Official WeChat)）
2025On April 17, CDE announced that IBI3020, a Class 1 new drug submitted by Innovent Bio, has been approved for clinical trials. It is intended for the treatment of unresectable, locally advanced or metastatic solid tumors. According to publicly available information from Innovent Bio, this is a dual-payload antibody-drug conjugate (ADC) targeting CEACAM5. This marks the product's first IND approval in China.
(Source: CDE official website, Pharmaceutical Observer)）
5. 3SBio | Anti-VEGF/PD-1 Bispecific Antibody 707 Granted Breakthrough Therapy Designation
2025April17Recently, 3SBio's independently developed, differentiated anti-PD-1/VEGF bispecific antibody with a novel molecular structure (R&D code: 707, Class 1 innovative drug) received Breakthrough Therapy Designation from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The indication is for first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with positive PD-L1 expression.
(Source: 3SBio)Official WeChat）
Editor: Sesame Walnut
Statement:This article only represents the author's personal views and does not reflect the position of any organization or this official account. If there are any inaccuracies, please kindly point them out. For reprints, please indicate the author and source:蒲公英Biopharma.
May 8 | Online |Dual-Dimension Unlocking of Contamination Prevention and Control Strategies in Aseptic Pharmaceutical Production
May 8 | Offline | Biomedical Talent Development Salon