Shil药 Group June 2026 Pipeline and Commercialization Highlights
CSPC
Innovative Drug Research and Development, Manufacturer
From May 29 to June 2, the American Society of Clinical Oncology (ASCO) Annual Meeting was grandly held in Chicago, USA. During the conference, Professor Zhang Li from the Sun Yat-sen University Cancer Center presented an oral report titled “SYS6043, a Novel B7-H3-Targeting Antibody-Drug Conjugate (ADC): A Phase I/II Clinical Study in Pan-Tumor Indications.” The results of this multicenter, single-arm, open-label Phase I/II study, led by Professor Zhang, were encouraging, suggesting that SYS6043 has the potential to become a therapeutic option for multiple tumor types.
Recently, multicenter teams from Suzhou Hongci Hematology Hospital, Hebei Yanda Lu Daopei Hospital, and other institutions published real-world study results in the international journal Drug Design, Development and Therapy (DOI: 10.2147/DDDT.S605938), systematically evaluating liposomal amphotericin B (L-AmB, brand name: AmBisome)®) Efficacy and Safety of Treating Hematologic Malignancies Complicated by Invasive Fungal Disease (IFD), Providing High-Quality Local Evidence for First-Line Clinical Medication.
On June 2, CSPC Pharmaceutical Group Limited (1093.HK) announced that the Group’s first mRNA-LNP-based dual-target chimeric antigen receptor (CAR)-T cell injection (SYS6063 Injection) has been approved by the National Medical Products Administration of the People’s Republic of China to conduct clinical trials in China.
On June 8, CSPC (1093.HK) announced that the long-acting injectable formulation of semaglutide (SYH9017), a GLP-1 receptor agonist developed by the Group, has been approved by the U.S. Food and Drug Administration (FDA) to conduct clinical trials in the United States.
On June 10, 2026, CSPC (stock code: 1093.HK) announced that its wholly-owned subsidiary, Shanghai Jinmante Biotechnology Co., Ltd., in collaboration with Alphamab Oncology (stock code: 9966.HK), had developed the HER2 bispecific antibody drug anitumab (KN026). The Phase III clinical study (protocol number: KN026-003) evaluating anitumab in combination with CSPC’s independently developed albumin-bound docetaxel (HB1801) as first-line treatment for HER2-positive advanced breast cancer successfully met the primary endpoint of progression-free survival (PFS), as assessed by the Independent Data Monitoring Committee (IDMC).
CSPC's Clevidipine Emulsion for Injection Has Been Approved for Market Launch
Traditional intravenous antihypertensive agents (such as second-generation calcium channel blockers, CCBs) have varying limitations in terms of onset of action, half-life, metabolic pathways, and safety. The formal approval of clevidipine not only fills a domestic gap but also represents the only approved ultra-short-acting CCB*, providing a new therapeutic option for such patients.
On June 15, CSPC (1093.HK) announced thatPaclitaxel for Injection (Albumin-bound) developed by the Group(Ⅱ)（100mg）Approved for marketing by the National Medical Products Administration of the People's Republic of China, it is the world's first instantly soluble albumin-bound paclitaxel formulation.
CSPC Enituo®(KN026) First Batch Shipment Nationwide!
On June 16, Shanghai Jinmante Biotechnology Co., Ltd., a wholly-owned subsidiary of CSPC Pharmaceutical Group Limited (stock code: 1093.HK), and Jiangsu Keymed Biosciences Inc. (stock code: 9966.HK) jointly developed Enitob®(Anitumab Injection, development code: KN026) completed its first nationwide shipment in China.
CSPC’s Marketing Authorization Application for Valsartan and Levamlodipine Maleate Tablets (SYH9056 Tablets) Accepted by the National Medical Products Administration
On June 16, CSPC Pharmaceutical Group Limited (1093.HK) announced that the National Medical Products Administration of the People's Republic of China has accepted the marketing authorization application for Valsartan and Levamlodipine Maleate Tablets (SYH9056 Tablets) developed by the Group. The indication for this submission is the treatment of mild to moderate essential hypertension that is not adequately controlled with monotherapy.
CSPC’s Octreotide Long-Acting Injection (SYHX2008) Receives Investigational New Drug Approval in the United States
On June 18, CSPC (1093.HK) announced that the long-acting octreotide injection (SYHX2008) (hereinafter referred to as “the Product”), developed by the Group, has received approval from the U.S. Food and Drug Administration (FDA) to conduct clinical trials in the United States.
CSPC’s Marketing Authorization Application for Secukinumab Injection Accepted by the National Medical Products Administration
On June 18, CSPC (1093.HK) announced that its subsidiary, CSPC Jushi Biopharmaceutical Co., Ltd.Secukinumab Injection Developed by CSPCThe marketing authorization application has been accepted by the National Medical Products Administration of the People's Republic of China. This prod-Products according to therapeutic biological products3.3Class Declaration.
CSPC’s Second Marketing Application for Idaglutide Alpha Injection Accepted by the National Medical Products Administration
On June 18, CSPC (1093.HK) announced that its subsidiary, CSPC Giant Stone Biopharmaceutical Co., Ltd.Secukinumab Injection Developed by CSPCThe marketing authorization application has been accepted by the National Medical Products Administration of the People's Republic of China. This productProducts as therapeutic biological products3.3Class declaration.
CSPC Budesonide Enteric-coated Capsules Officially Shipped
On June 18, a refrigerated truck carrying the first batch of CSPC’s budesonide enteric-coated capsules slowly departed from the production facility of CSPC Xingshi Pharmaceutical Co., Ltd., officially marking the launch of CSPC’s®The Commercialization Path of Budesonide Enteric-Coated Capsules. The launch of this product will enrich the etiological treatment options for IgA nephropathy, reduce medication costs, and effectively improve drug accessibility for patients with IgA nephropathy.
CSPC’s Innovative Drug Research Findings Published in Cancer Letters
The Phase III clinical study results of SYHX2011 (an innovative albumin-bound paclitaxel nano-formulation) developed by CSPC for patients with advanced breast cancer were successfully published in Cancer Letters (Cancer Communications，IF：24.9, titled Albumin-Bound Paclitaxel (SYHX2011) in Patients with Advanced Breast Cancer: A Multicenter, Randomized, Double-blind, Phase III Study.
Eight Years at the Forefront! CSPC’s Innovation Strength Receives Authoritative Recognition Again
Recently, the “Top 100 Innovative Pharmaceutical Enterprises in China 2026” list was prominently released by E-Pharma Manager. Leveraging its innovation capabilities, CSPC once again made the list, marking its eighth consecutive year of inclusion and firmly securing its position in the top tier.
Evidence-Based and Data-Driven: rhTNK-tPA Leads a New Era of Precision Recanalization in Intravenous Thrombolysis
From June 26 to June 28, the 12th Academic Annual Conference of the Chinese Stroke Association and the Tiantan International Stroke Conference (CSA & TISC 2026), hosted by the Chinese Stroke Association, was grandly held in Beijing. As one of the most anticipated academic segments of this year’s Tiantan Conference, the forum titled “The New Era of Reperfusion Therapy for Ischemic Stroke,” which commenced on the afternoon of June 27, brought together numerous experts and scholars in the field of cerebrovascular diseases from both domestic and international communities. They jointly discussed the current overall landscape of stroke prevention and control in China, witnessed the evidence-based breakthroughs and real-world application of Chinese recombinant tenecteplase (rhTNK-tPA) in the reperfusion therapy for acute ischemic stroke (AIS), and explored the reshaping of future treatment models for AIS.
[Statement]
1. This press release is intended to share research progress information and is not for advertising purposes;2. This material is for reference by healthcare professionals only; it does not constitute a basis for product recommendation and should not be regarded as medical advice or diagnostic guidance.
