The 2025 American Society of Clinical Oncology (ASCO) Annual Meeting is in full swing, and the original innovative drug LBL-024 from China has once again become the focus. The drug is a 4-1BB/PD-L1 bispecific antibody that is expected to fill the gap in the clinical treatment of extrapulmonary neuroendocrine carcinoma (EP-NEC). At the same time, positive efficacy signals have been observed in multiple cancer types such as small cell lung cancer and biliary tract cancer. It is worth noting that LBL-024 has entered the critical clinical trial stage. If approved, it will become the world’s first 4-1BB target drug, and will also make 4-1BB the world’s fourth druggable immune checkpoint after PD-1/L1, CTLA-4, and LAG3. 01 The world’s first! LBL-024 breaks through again The American Society of Clinical Oncology (ASCO) Annual Meeting is the world’s largest, most academically advanced and most authoritative clinical oncology conference, and the selected oral reports ...
On May 29, GENOR Bio (06998) issued an announcement that the China National Medical Products Administration has approved the new drug application for Leloxili (GB491). Leroxili (GB491) is a novel, highly potent and selective oral cyclin-dependent kinase 4 and 6 inhibitor co-developed with G1 Therapeutics Inc., designed to improve the treatment of patients with advanced breast cancer. The drug is indicated for adult patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer, and can be used in combination with aromatase inhibitors as initial endocrine therapy, or in combination with fulvestrant for patients whose disease has progressed after previous endocrine therapy. https://finance.eastmoney.com/a/202505293417987240.html
On May 29, Mywell Biopharmaceuticals (688062) announced that the marketing application for Agrastim α for injection submitted by its wholly-owned subsidiary Jiangsu Taikang Biotechnology Co., Ltd. was approved by the National Medical Products Administration. The drug is suitable for adult patients with non-myeloid malignancies who are receiving myelosuppressive anticancer drugs that are prone to cause febrile neutropenia. The drug can be used to reduce the incidence of infections manifested by febrile neutropenia.The marketed product is also the first domestically marketed G-CSF drug developed using long-acting albumin fusion technology. In the first quarter of 2025, Mabwell Biopharmaceuticals achieved revenue of 44.79 million yuan and a net profit attributable to shareholders of the parent company of -292 million yuan. https://finance.eastmoney.com/a/202505293418060776.html
On May 29, Fuyuan Pharmaceutical(601089) issued an announcement that its wholly-owned subsidiary Fuyuan Pharmaceutical Co., Ltd. received the “Drug Clinical Trial Approval Notice” for Lidocaine Prilocaine Aerosol approved and issued by the State Drug Administration. Lidocaine Prilocaine Aerosol meets the relevant requirements for drug registration and is approved for clinical trials. Fuyuan Pharmaceutical Co., Ltd. has applied for clinical trials for lidocaine prilocaine aerosol, which is suitable for the treatment of primary premature ejaculation in adult men. The route of administration is local, and the registration classification is chemical drug class 3. So far, Fuyuan Pharmaceutical has invested approximately RMB 9.5477 million in the research and development of this product. In the first quarter of 2025, Fuyuan Pharmaceutical achieved revenue of 830 million yuan and net profit attributable to shareholders of the parent company of 131 million yuan. https://finance.eastmoney.com/a/202505293418053486.html
The reporter learned from Fosun Pharma on May 28 that the company recently reached an agreement with Jiuyuan Gene on a number of biological drugs and innovative drugs.A signing ceremony for the exclusive overseas commercialization rights cooperation of medical products was held in Hangzhou. According to the agreement, Fosun Pharma obtained exclusive authorization from Jiuyuan Gene for the exclusive clinical development, registration, production and commercialization rights of products such as semaglutide, Bone Youdao and JY-23 in all countries in the Middle East and North Africa, sub-Saharan Africa and some ASEAN countries. Chen Yuqing, Chairman of Fosun Pharma, said: “We are very pleased to work with Jiuyuan Gene to promote the development and commercialization of multiple biopharmaceuticals and innovative medical devices in overseas markets. This cooperation is not only a deep synergy of the technical strength and resource endowment of both parties, but also aThis is another important milestone in our ...
On May 29, InnoCare Pharma announced that the company’s independently developed new BCL2 inhibitor Mesutoclax (ICP-248) combined with azacitidine was approved by the National Medical Products Administration (NMPA) Drug Review Center (CDE) to conduct clinical studies for the treatment of myeloid malignancies, including but not limited to myelodysplastic syndrome (MDS). It is understood that ICP-248 is a new oral, highly selective BCL2 inhibitor. BCL2 is an important regulatory protein in the cell apoptosis pathway, and its abnormal expression is associated with the occurrence and development of a variety of malignant blood tumors. ICP-248 selectively inhibits BCL2 and restores the programmed cell death mechanism of tumor cells, thereby exerting anti-tumor efficacy. Myelodysplastic syndrome (MDS) is a myeloid neoplasm characterized by clonal proliferation of hematopoietic stem cells, recurrent genetic abnormalities, myeloid cell dysplasia, ineffective hematopoiesis, peripheral blood cell reduction, and a high risk of transformation to acute myeloid leukemia (AML). Approximately one-third ...
On May 29, Humanwell Pharmaceutical issued an announcement that its holding subsidiary Yichang Renfu Pharmaceutical Co., Ltd. recently received the “Drug Clinical Trial Approval Notice” for RFUS-949 tablets approved and issued by the National Medical Products Administration, agreeing to conduct clinical trials of this product for acute and chronic pain. RFUS-949 is a new molecular entity developed by Yichang Renfu, and is registered as a Class 1 chemical drug. RFUS-949 tablets are intended to be used clinically for the treatment of acute and chronic pain. Currently, no similar products have been approved for marketing in China. So far, Yichang Renfu’s cumulative R&D investment in this project is approximately RMB 15 million. In the first quarter of 2025, Renmin Pharmaceutical achieved revenue of 6.137 billion yuan and net profit attributable to shareholders of the parent company of 540 million yuan. https://finance.eastmoney.com/a/202505293417929589.html
May 29, Sunshine Novo(688621) issued an announcement that the Phase II clinical trial of STC007 injection independently developed by the company’s wholly-owned subsidiary Novo Shengtai for the treatment of moderate to severe pain after abdominal surgery has achieved the expected goals. The clinical trial involved 156 subjects and mainly evaluated the efficacy, safety and pharmacokinetic characteristics of STC007 injection. The results showed that STC007 injection significantly improved the pain scores of subjects within 0-24 hours after surgery, and performed better than the control group in terms of the amount of rescue treatment drugs used and the time to first rescue treatment. In terms of safety, the overall safety and tolerability of STC007 injection were good, no new safety signals were found, and no serious adverse events occurred .Due to the high risk of R&D, investors need to make careful decisions. In the first quarter of 2025, Sunshine Novo achieved revenue ...
According to the website of the National Medical Products Administration, the National Medical Products Administration has recently conditionally approved the marketing of Ruikang Trastuzumab for Injection (trade name: Avida) submitted by Suzhou Shengdia Biopharmaceutical Co., Ltd. through the priority review and approval procedure. The single drug is suitable for the treatment of adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) who have HER2 (ERBB2) activating mutations and have received at least one systemic treatment in the past. The launch of this product provides a new treatment option for related patients. https://finance.eastmoney.com/a/202505293418294646.html
On Wednesday, US Eastern Time, American vaccine manufacturer Moderna announced that it had withdrawn its application for marketing authorization for the combined COVID-19 and influenza vaccine to wait for more efficacy data of its vaccine. Affected by this news, its stock price fell by more than 6% during the trading session. Moderna said it will resubmit its application later this year with effectiveness data from its standalone flu vaccine in a large-scale trial, which is expected to be released this summer. Earlier this month, Moderna claimed, largely as expected, that it did not expect regulators to approve the vaccine until 2026 because more data on its flu vaccine was needed. It is worth noting that the day before Moderna made this decision, the United States tightened the approval requirements for the new crown vaccine. The U.S. Food and Drug Administration (FDA) said that the approval of new crown vaccines for ...
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