media – Page 16 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

GB19 Injection Approved for Clinical Trials of Cutaneous Lupus Erythematosus

Kexing Biopharmaceutical(688136) announced on March 4 that its wholly-owned subsidiary, Shenzhen Kexing Biopharmaceutical Co., Ltd., has independently developed an innovative drug targeting BDCA2 (blood dendritic cell antigen 2).The drug “GB19 Injection” received the “Drug Clinical Trial Approval Notice” issued by the National Medical Products Administration, which approved it to conduct clinical trials for the indication of cutaneous lupus erythematosus (CLE). According to the announcement, GB19 injection targets BDCA2, a target specifically expressed on the surface of plasmacytoid dendritic cells (pDCs), and its mechanism of action differs significantly from existing clinical drugs targeting the B cell pathway. By specifically binding to BDCA2, it can inhibit the production of type I interferon by pDC cells, intervening in the abnormal activation loop between innate and adaptive immunity. Preclinical studies have shown that GB19 possesses good in vitro activity, immunogenicity, high bioavailability, and maintains target inhibition for over 90 days, exhibiting excellent safety profile. ...
- Source: drugdu
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- March 4, 2026
First patient dosing completed for KRAS G12D inhibitor ABSK141

On the morning of March 4th, Heyu -B (02256) announced that its subsidiary, Shanghai Heyu Biopharmaceutical Technology Co., Ltd., has successfully completed the first patient dosing in a Phase I/II clinical trial of its oral, highly effective, and selective small molecule KRAS G12D inhibitor, ABSK141, for patients with advanced solid tumors harboring KRAS G12D mutations. This progress marks a significant milestone for Heyu Pharmaceuticals in the field of KRAS-targeted therapy, and is expected to provide a transformative potential treatment option for patients with KRAS G12D-mutated solid tumors. According to the announcement, KRAS is one of the most common oncogenes in human cancers, with G12D being the major mutation subtype, widely found in various solid tumors such as pancreatic ductal adenocarcinoma, colorectal cancer, and non-small cell lung cancer. Because G12D mutations lead to specific conformational changes in the KRAS protein, it has long been considered an “untreatable” target, and currently, no ...
- Source: drugdu
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- March 4, 2026
China Sino Biopharmaceutical Signs Exclusive Licensing Agreement with Sanofi for Rofalcitinib

On March 4, Sino Biopharmaceutical Limited (1177.HK) announced that it has entered into an exclusive licensing agreement with Sanofi for rofalcitinib, a first-in-class, novel and potent oral small-molecule JAK/ROCK inhibitor. Under the agreement, Chia Tai Tianqing, a subsidiary of Sino Biopharmaceutical, grants Sanofi an exclusive license for the global development, manufacturing and commercialization of rofalcitinib. Sino Biopharmaceutical is eligible to receive up to **US$1.53 billion** in payments, including a US$135 million upfront payment, as well as potential development, regulatory and sales milestone payments. In addition, the company will receive tiered royalties at up to double-digit percentages based on the annual net sales of rofalcitinib. The agreement is subject to customary closing conditions, including approval from relevant regulatory authorities. Xie Qirun, Chairman of the Board of Directors of Sino Biopharmaceutical, stated: “We are delighted to join hands with Sanofi to bring the first-in-class JAK/ROCK inhibitor to patients worldwide. This collaboration represents ...
- Source: drugdu
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- March 4, 2026
【EXPERT Q&A】Can multiple manufacturing enterprises be entrusted to produce medical devices?

Drugdu.com expert’s response: Chinese Current Regulations Have Lifted the “Only One Contract Manufacturer” Restriction Medical device registrants/filers may entrust multiple qualified enterprises to manufacture products. I. Regulatory Basis Regulation on the Supervision and Administration of Medical Devices (Order No. 739) Registrants/filers may entrust qualified enterprises to manufacture medical devices; no limit on the number of contract manufacturers. Measures for the Supervision and Administration of Medical Device Production It explicitly allows registrants to entrust multiple manufacturers. A quality and risk capability assessment shall be conducted for each entrusted enterprise; a delegation agreement + quality agreement shall be signed and supervision shall be implemented. NMPA Announcement No. 38 of 2024 Supports multiple entrustment and requires the registration certificate to list all entrusted manufacturers. II. Two Common Models 1. Multiple Entrustment for Finished Products (Multi‑source Supply) Entrust the same finished product to multiple manufacturers to expand ...
- Source: drugdu
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- March 4, 2026
Gan & Lee Pharmaceuticals’ new PROTAC drug GLR2037 tablets have been approved for clinical trials to enter the field of prostate cancer treatment

On the evening of March 2, Gan & Lee Pharmaceuticals announced that its independently developed Class 1 chemical new drug, GLR2037 tablets, received the “Drug Clinical Trial Approval Notice” issued by the National Medical Products Administration (NMPA) for the treatment of advanced prostate cancer. This marks the first time Gan & Lee Pharmaceuticals has extended its R&D pipeline to the field of prostate cancer treatment, and it is also the company’s first investigational product to enter the clinical stage on the emerging protein degradation targeted chimeric (PROTAC) technology platform. According to the announcement, GLR2037 tablets are a Class 1 new chemical drug developed independently by Gan & Lee Pharmaceuticals , targeting a protein degradation chimeric antibody (AR PROTAC). Currently, no PROTAC products have been approved for marketing globally. It is understood that this drug selectively degrades target proteins related to disease pathogenesis by utilizing the cell’s natural ubiquitin-proteasome system. Unlike ...
- Source: drugdu
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- March 3, 2026
AideaPharmaceuticals plans to raise no more than 1.277 billion yuan through a private placement to focus on the global clinical development of innovative HIV drugs

On the evening of March 2nd, AideaPharmaceutical…The company announced that it plans to raise no more than RMB 1.277 billion through a private placement of shares. The funds will be invested in three main areas: RMB 767 million for the global clinical development of a novel HIV integrase inhibitor; RMB 130 million for the acquisition of a 22.23% minority stake in Nanda Pharmaceutical; and RMB 380 million to supplement working capital. Fu Heliang, one of the company’s actual controllers and chairman, plans to subscribe for RMB 30 million to RMB 50 million of the issued shares. AideaPharmaceuticals , as an innovative anti-HIV drug manufacturer in ChinaAs a leading company, it has already launched two Class 1 innovative drugs in China : Enovilin and Enovitil. Currently, integrase inhibitors have become one of the mainstream treatment options for HIV/AIDS globally. In China, there are currently no independently developed innovative HIV integrase inhibitors ...
- Source: drugdu
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- March 3, 2026
Giant Exits! Its Star Business Acquired

According to recent foreign media reports, Quantum Surgical has completed its acquisition of NeuWave Medical, a Johnson & Johnson subsidiary. Financial details of the transaction have not yet been disclosed. Furthermore, it is worth noting that the two companies will become subsidiaries of the newly formed holding company, Precision IO Group Inc.According to Johnson & Johnson, NeuWave Medical is a leading provider of interventional oncology solutions in the United States, and was acquired by Johnson & Johnson in 2016. According to data from PharmNet Medical Devices, NeuWave currently has 14 products on the market in the United States , including the Certus air-cooled microwave ablation device and disposable microwave ablation needles, primarily used for image-guided tumor ablation therapy. In 2020, NeuWave Medical officially entered China, and currently has two products on the market in China : a microwave ablation therapy device and a disposable microwave ablation puncture needle. In 2025, ...
- Source: drugdu
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- March 3, 2026
Focusing on cardiovascular and cerebrovascular diseases! OpenMediLead Medical Intelligence Dual Engines Launch Internal Testing, Connecting Drug Development and Clinical Diagnosis in a Closed Loop

Recently, the OpenMediLead platform, focusing on the cardiovascular and cerebrovascular field, officially entered its internal testing phase on WeChat mini-program. The platform centers on the interactive testing of its AI drug discovery engine and AI clinical diagnostic decision-making engine. Utilizing a lightweight mini-program entry point, it conducts real-world scenario verification and collects user feedback, laying a crucial foundation for the next step of officially establishing a closed-loop system between clinical practice and research. It aims to reconstruct a new model of medical and pharmaceutical integration using artificial intelligence technology, facilitating precise diagnosis and treatment of cardiovascular and cerebrovascular diseases and the efficient development of innovative drugs. OpenMediLead was founded by Li Chengli and his core team. The platform has a clear and firm core value: with the vision of “building an ecosystem of artificial intelligence in medicine and pharmaceuticals”, and the mission of “making medical knowledge and pharmaceuticals less difficult ...
- Source: drugdu
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- March 3, 2026
Innovent Biologics Announces Approval of New Indication for BTK Inhibitor “Pitubrutinib” in China

On March 2, Innovent Biologics and Eli Lilly and Company China jointly announced that the non-covalent (reversible) BTK inhibitor Japalli® (pitubrutinib) has been officially approved by the National Medical Products Administration (NMPA) of China for a new indication: the treatment of adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who have previously received at least one systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor. Pitobrutinib is a highly selective kinase inhibitor with a novel binding mechanism that can re-establish BTK inhibition in CLL/SLL patients who have previously received covalent BTK inhibitors (including ibrutinib, acomitinib, zanubrutinib, or orelabrutinib), thus prolonging the benefits of targeting the BTK pathway. Pitobrutinib, as a non-covalent (reversible) BTK inhibitor, was approved by the US FDA in January 2023. In October 2024, pitotubactinib was approved in China as monotherapy for adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at ...
- Source: drugdu
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- March 3, 2026
Huadong Medicine’s subsidiary, Daer Bio, has received IND approval in China for its DR30206 injection in combination with chemotherapy for the treatment of non-small cell lung cancer

Recently, Zhejiang Daer Biotechnology Co., Ltd. (hereinafter referred to as “Daer Biotechnology”), a holding subsidiary of Huadong Medicine Co., Ltd. (hereinafter referred to as “the Company”), received the “Drug Clinical Trial Approval Notice” (Notice No.: 2026LP00516) issued by the National Medical Products Administration (NMPA). The clinical trial application for DR30206 for injection submitted by Daer Biotechnology was approved, with the indication being: this product in combination with standard chemotherapy, intended for patients with locally advanced or metastatic non-small cell lung cancer. DR30206 for injection is a Class 1 therapeutic biological product independently developed by Daer Biotech and possessing global intellectual property rights. DR30206 is an antibody fusion protein targeting PD-L1, VEGF, and TGF-β; it restores the proliferation of exhausted CD8+ T cells by blocking the PD-1/PD-L1 signaling pathway; and reduces tumor angiogenesis and relieves immunosuppression by specifically binding to free VEGF and TGF-β, thereby achieving the goal of treating tumors. ...
- Source: drugdu
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- March 3, 2026

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