Shijiazhuang Pharma Submits HER2 mAb for Approval, China Resources Sanjiu Secures Rare Disease Drug Rights, and Simcere's CAR-T Achieves $860M Global Licensing Deal

Nov 11, 2025 19:05 CST Updated 19:05

CSPC

Innovative Drug Research and Development, Manufacturer

CHIATAI TIANQING

High-quality pharmaceuticals research, production, and sales provider

Qilu Pharmaceutical

Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer

Henlius

Innovative Biopharmaceutical Company

CR SANJIU

Pharmaceutical R&D, Production, Sales, and Related Health Service Provider

Lyell Immunopharma

Cell Therapy New Drug Developer

CSPC's Pertuzumab Marketing Application Accepted

11Month11Day,CDEThe official website shows that the marketing application for Pertuzumab Injection submitted by CSPC has been accepted for the treatment ofHER2Positive Breast Cancer. Notably, this is the first in China.5Pertuzumab biosimilar submitted for marketing approval.

Pertuzumab isOriginally developed by RocheAHER2Monoclonal antibodies, through targetingHER2The extracellular dimerization domain (subdomainⅡ), blockingHER2Compared with othersHER2Family members (includingEGFR、HER3AndHER4) Generate ligand-dependent heterodimers, thereby blocking signaling pathways and inhibiting tumor cell growth.

Pertuzumab2012Year of First ApprovalUnited StatesFDAApproved for marketing,2018First approved for marketing in China in [Year]。Although impacted by biosimilars,Roche'sPertuzumabIn2024YearGlobalSales RevenueStill as high as40.97hundred million US dollars. Currently, CHIATAI TIANQING and Qilu Pharmaceutical in ChinaThePertuzumab Biosimilar Approved for Marketing in China. Additionally, apart from CSPCGroupIn addition, the pertuzumab biosimilar developed by Shanghai Henlius Biotech, Inc. and Zhejiang Borui Biopharmaceutical Co., Ltd. has also been submitted for marketing approval.

CR SANJIU Obtains Exclusive Rights in Mainland China for Innovative Narcolepsy Drug

11Month10CR SANJIU announced recently that it has signed with Langyu Group,BioprojetThe three parties signed an agreement, officially obtaining the exclusive rights to develop, manufacture, and commercialize the innovative drug Tilorone tablets (brand name: Huake's) held by Langyu Group in mainland China.

Narcolepsy is a rare chronic neurological disorder characterized by impaired ability of the brain to maintain wakefulness and sleep. Narcolepsy is generally considered a lifelong condition, with patients often experiencing recurrent and irresistible daytime sleepiness, cataplexy, hypnagogic hallucinations, and sleep paralysis."Symptoms of Tetralogy" not only affect normal life but also pose risks of injury or even death after a fall. It is estimated that globally, there are approximately300More than 100,000 patients with narcolepsy in China, the potential number of narcolepsy patients in our country is approximately...30Ten Thousand~7010,000 people.

Tilolorist TabletsIt is the first innovative drug approved in China for the treatment of narcolepsy and also the first and currently the only non-controlled psychotropic drug for this condition, which has been granted approval for"Quad Symptoms" including excessive daytime sleepiness, cataplexy, hypnagogic hallucinations, and sleep paralysisIGrade Recommendation (Highest Recommendation Level) &ALevel A evidence (the highest level of evidence) and is recommended by guidelines from countries such as the United States and Europe worldwide.

At the same time,Tilolorant TabletsThe indication for obstructive sleep apnea has been approved in Europe, aligning with CR SANJIU's strategic layout in the respiratory field.

Stemirna GCC19 CAR-T Surpasses $860 Million in Overseas Deal

11Month10Day,Lyell ImmunopharmaAnnounced that it has obtained the development of Sidansai Bio.LYL273(Formerly known asGCC19CART) Global rights outside Greater China, further strengthening its position in solid tumorsCAR-TResearch and development layout in the field.

Sidansai Biotech will obtain4000Million USD Prepayment and19010,000 sharesLyellCommon stock, and are eligible to receive additional cash and equity consideration in the future, as well as tiered royalties based on net sales.Among them,Extra Cash Includes Potential3000Million USD Clinical Milestone Payment, up to1.15Hundreds of millions of dollars in late-stage regulatory milestones, as well as the highest6.75Hundreds of millions of dollars in commercial sales milestones; equity consideration includes up to a certain amount upon achieving specific clinical or regulatory milestones.18510,000 sharesLyellCommon Stock.

LYL273It is a product targeting guanylate cyclase.-C（GCC) of a new type of autologousCAR-TCell candidate product, mainly used for the treatment of metastatic colorectal cancer (mCRC) and other expressionsGCCSolid tumors. The product is throughCD19-CARExpression and Controlled Cytokine Release Technology Optimization Design, Aimed at EnhancingCAR-TThe amplification capacity, immune infiltration, and anti-cancer effects of cells in an unfavorable solid tumor microenvironment. Currently，LYL273Has obtained the United StatesFDAGrantedmCRCFast Track Designation.