Johnson & Johnson's Rykera Gains New Indication in China; Akeso/Tianqing and Huadong/Shinoken Report Clinical Progress

Apr 25, 2025 20:11 CST Updated 20:11

Johnson & Johnson

Medical Device R&D and Manufacturer

Akeso

Innovative Antibody Drug Developer

CHIATAI TIANQING

High-quality pharmaceuticals research, production, and sales provider

Huadong Medicine

Large Comprehensive Pharmaceutical Product Developer

Synerk

Small Nucleic Acid Drug Developer

Johnson & Johnson's Amivantamab Approved for New Indication in China

TodayJohnson & Johnson announced that its innovative therapeutic drug, Synerk®(Evolumab Injection) OfficiallyObtainNMPAApproved, in combination with carboplatin and pemetrexed, for the treatment of patients with epidermal growth factor receptor (EGFR）19Exon deletion or21Extra ExonL858RSubstitution mutation and inEGFRLocally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with disease progression during or after tyrosine kinase inhibitor treatmentNSCLC) Adult patients.

It is reported that this approval marks the second lung cancer indication for Amivantamab in China this year.Previously, Ruike® has been approved in February this year for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer carrying EGFR exon 20 insertion mutations.

[Source: Johnson & Johnson Official WeChat]

Notably, the approval of this new indication is based on the robust efficacy and safety data from the Phase III MARIPOSA-2 study. Based on the results of the MARIPOSA-2 clinical trial, the National Comprehensive Cancer Network's (NCCN) Clinical Practice Guidelines recommend amivantamab in combination with chemotherapy as the sole Category 1 preferred treatment option for patients with advanced NSCLC harboring classic EGFR mutations who have progressed after osimertinib treatment.

Akeso & CHIATAI TIANQING’s Penpulimab Approved by FDA

DayFront`, United States`FDAAnnouncement of Approvalpenpulimab-kcqx(Penpulimab) Two indications, respectively: in combination with cisplatin or carboplatin and gemcitabine for recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC) First-line treatment for adult patients; monotherapy for adult metastatic non-keratinizing nasopharyngeal carcinoma, in patients who have experienced disease progression during or after platinum-based chemotherapy and at least one other prior therapy.

[Source: FDA Official Website]

Public information shows that Penpulimab is a novel differentiated anti-PD-1 monoclonal antibody using the IgG1 subtype with Fc segment modification, which can more effectively enhance the efficacy of immunotherapy and reduce adverse reactions. The product was independently developed by Akeso and subsequent development and commercialization are being handled by Chia Tai Tianqing Kangfang, a joint venture between Akeso and CHIATAI TIANQING.

Previously, Penpulimab has been approved in China for four indications: first-line treatment in combination with chemotherapy for locally advanced or metastatic squamous non-small cell lung cancer, relapsed or refractory classical Hodgkin's lymphoma after at least two lines of systemic chemotherapy, recurrent/metastatic nasopharyngeal carcinoma that has failed second-line or above systemic treatment, and first-line treatment in combination with chemotherapy.Recurrent or Metastatic Non-Keratinizing Nasopharyngeal Carcinoma。

Huadong Medicine & Synerk New Drug Approved for Clinical Trials in China

Recently,CDEOfficial website latest announcement,Synerk Pharmaceutical Technology (Suzhou) Co., Ltd. submitted1New Drug ClassSNK-2726Injection solution approved for clinical trials, intended for hypertension treatment.

It is reported that,This is a targeted angiotensinogen drug jointly developed by Huadong Medicine and Synerk Pharmaceutical Technology.AGT) Small Nucleic Acid (siRNA) Candidate drug.The product has been2Approved in the U.S. in [Month]IND, this is the first approval of the product in China.IND。

【Source: CDE Official Website】

Public information shows that SNK-2726 Injection, developed by Synerk Pharmaceutical Technology (Suzhou) Co., Ltd., is an siRNA drug targeting AGT. Administered via subcutaneous injection, it inhibits the production of AGT at its source, blocking the Renin-Angiotensin-Aldosterone System (RAAS), thereby achieving a systemic blood pressure-lowering effect. Preclinical research results indicate that SNK-2726 can profoundly suppress the synthesis of AGT in the liver, leading to a sustained reduction in AGT protein levels and exerting a long-lasting blood pressure-lowering effect.

Editor: Li Yongshi

Layout Editor: Yu Yuanze

Reviewed by: Ma Fei, Zhang Song

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