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GSK Expands Again in Cancer, Paying Hansoh $185M for Another ADC

GSK gains rights to a Hansoh Pharma antibody drug conjugate that targets a protein abundant on lung cancer cells and other types of solid tumors. The pharmaceutical giant plans to start its own slate of clinical trials with this ADC in 2024. By FRANK VINLUAN GSK’s cancer drug pipeline is getting bigger with the addition of another antibody drug conjugate, or ADC. It’s the second time in as many months that GSK has turned to Hansoh Pharma for one of the China-based biotech’s drugs. Per deal terms announced Wednesday, GSK is paying $185 million up front for rights to HS-20093, a Hansoh ADC that has been tested in lung cancer. GSK gains global rights to the drug candidate excluding mainland China, Hong Kong, Macau, and Taiwan. ADCs are made by chemically linking an antibody to a toxic drug payload. The targeting ability of the antibody is meant to provide a ...
- Source: drugdu
- 258
- December 22, 2023
Calliditas wins over FDA for full approval, broader label on kidney disease drug Tarpeyo

Two years after securing an accelerated approval for its primary immunoglobulin A nephropathy (IgAN) therapy Tarpeyo (budesonide), Calliditas Therapeutics has scored a full FDA endorsement for the oral, delayed-release drug. Tarpeyo becomes the first treatment fully approved in the United States specifically for the chronic autoimmune kidney condition, also known as Berger’s disease. While some graduations from accelerated to full approval are ceremonial, this endorsement carries extra weight as it expands the label for Tarpeyo, allowing it to be accessed by all patients with IgAN. Perviously, the FDA limited the med’s use to those at risk for rapid disease progression. The expansion was facilitated by a confirmatory trial, which was the first phase 3 IgAN study to show significant improvement in estimated glomerular filtration rate (eGFR), which is the most reliable measure of kidney function. The results showed that Tarpeyo can reduce the time to kidney failure by 30%, potentially ...
- Source: drugdu
- 322
- December 22, 2023
Palatin sells female libido drug Vyleesi to Cosette for $12M, plus more in potential milestones

In 2020, Palatin Technologies paid $12 million to regain the rights in North America to its struggling female libido drug Vyleesi. Three years later, the New Jersey company has sold the treatment for the same up-front figure—$12 million—in a deal that indicates the medicine is unlikely to ever make a significant impact in the market. The new buyer for Vyleesi, which was approved by the FDA in 2019, is another New Jersey drugmaker, Cosette Pharmaceuticals, which also is on the hook for $159 million in contingent, sales-based milestones. As one of two drugs hailed to potentially become the “female Viagra,” Vyleesi has not lived up to expectations. In September, when Palatin revealed its quarterly earnings, it reported fiscal-year sales of $12.5 million, compared to $5.8 million in the previous fiscal year. While Palatin CEO Carl Spana, Ph.D., said in a release that he was “excited” that Vyleesi’s net product revenue ...
- Source: drugdu
- 270
- December 22, 2023
Kunming Plasma Products, a subsidiary of China National Pharmaceutical Group (Sinopharm), has been selected for the list of Intelligent Manufacturing Demonstration Factories in 2023.

The announcement, jointly released by the Ministry of Industry and Information Technology, the National Development and Reform Commission, the Ministry of Finance, the State-owned Assets Supervision and Administration Commission of the State Council, and the State Administration for Market Regulation, highlights Kunming Plasma Products’ achievement in intelligent manufacturing by making it to the ‘2023 Intelligent Manufacturing Demonstration Factories’ list. This recognition marks a new milestone in Kunming Plasma Products’ efforts towards intelligent manufacturing and digital factory construction. As a crucial component of China’s ’14th Five-Year Plan’ Intelligent Manufacturing Pilot Demonstration Action, the national-level Intelligent Manufacturing Demonstration Factories and Outstanding Scenes are part of a major national project led jointly by the Ministry of Industry and Information Technology, the National Development and Reform Commission, the State-owned Assets Supervision and Administration Commission of the State Council, the Ministry of Finance, and the State Administration for Market Regulation. The initiative aims to select ...
- Source: drugdu
- 251
- December 22, 2023
The clinical Phase III study results of the BIO-THERA Tocilizumab biosimilar, TOFIDENCE™, have been published in The Lancet Rheumatology.

The clinical Phase III study results of the BIO-THERA Tocilizumab biosimilar, TOFIDENCE™ (BAT1806/BIIB800), have been published in the prestigious international rheumatology journal, The Lancet Rheumatology (impact factor IF = 25.4). This research, derived from a global multicenter, randomized, double-blind, active-controlled Phase III clinical study (ClinicalTrials.gov, NCT03830203; EudraCT, 2018-002202-31), reveals outcomes from the initial treatment phase (TP1). The study, conducted in 54 centers across five countries (China, Ukraine, Poland, Georgia, Bulgaria), included a 24-week initial treatment phase (TP1) followed by a subsequent 24-week secondary treatment phase (TP2). A total of 621 patients with moderate to severe rheumatoid arthritis, unresponsive to methotrexate, were enrolled. During the trial, participants received investigational drug therapy with an initial dose of 8mg/kg, administered intravenously every four weeks, either BAT1806/BIIB800 or the reference Tocilizumab. The study consisted of two treatment stages (TP1 and TP2), with 50% of the control group transitioning to BAT1806/BIIB800 treatment in TP2 until ...
- Source: drugdu
- 182
- December 22, 2023
InxMed Enters License Agreement with Escugen to Develop Next-Generation ADCs

Nanjing, China– InxMed, a clinical-stage biotechnology company dedicates on developing innovative therapies against drug resistance, and Escugen, a clinical-stage antibody–drug conjugate (ADC) company, today announced that InxMed licensed EZWi-Fit® linker-payload platform from Escugen for the development of the next generation tumor-associated antigens (TAAs) targeting ADCs. The license agreement provides InxMed with right to use EZWi-Fit® platform on the several novel ADC candidate molecules. InxMed will have the right for development, manufacturing, and commercialization of these ADC candidate molecules. InxMed is developing next generation TAAs targeting ADCs with significant improvement of efficacy and therapeutic window. Meanwhile, the company is developing solutions to boost ADC’s efficacy including enhancing ADC penetration via FAK inhibitor and developing stroma targeting ADC to create synergy. InxMed is positioned to invent next generation ADCs, with the attributes to be more tumor selective and potent, and broad combination potential. The novel antibodies discovered by InxMed to be equipped ...
- Source: drugdu
- 143
- December 22, 2023
China updates guidelines for vaccination practices

BEIJING — China has released new vaccination guidelines to enhance standardized immunization management, according to the National Disease Control and Prevention Administration. The updated guidelines, a revision of the 2016 version, mandate standardized requirements for vaccination practices, including vaccine-use management, the monitoring and handling of suspected adverse reactions, as well as vaccination-rate surveillance. According to the guidelines, disease control agencies and vaccination centers should implement a routine vaccine inspection system. This involves monthly checks on factors such as vaccine quantity, source, packaging, storage temperature and expiration date, with records maintained. In China, vaccines are categorized into immunization plan vaccines, mandated by government regulations, and non-immunization plan vaccines, which residents voluntarily choose, excluding those specified in the official immunization plan. http://english.nmpa.gov.cn/2023-12/18/c_948768.htm
- Source: drugdu
- 185
- December 22, 2023
【EXPERT Q&A】What documents are needed and what is the specific process for exporting medical equipment?

Drugdu.com expert’s response: Exporting medical equipment requires a thorough understanding of the regulatory requirements of both the exporting and importing countries, and involves several steps and essential documents: 1.Regulatory Compliance Compliance with Exporting Country Regulations: Ensure the medical equipment meets the regulatory standards of the country of origin. Compliance with Importing Country Regulations: Understand and comply with the medical device regulations of the destination country, which may include certifications like CE Marking (for Europe) or FDA approval (for the United States). 2.Essential Documents Export License: Depending on the type of equipment and the destination, an export license may be required. Commercial Invoice: Details the transaction between the exporter and importer. Packing List: Describes the contents and packaging details of the shipment. Bill of Lading or Airway Bill: Used for the shipment of goods. Certificate of Origin: States where the equipment was manufactured. Product Certifications: Documents like CE Certificate or FDA ...
- Source: drugdu
- 265
- December 22, 2023
FDA drafts guidance outlining real-world evidence for medical device submissions

Dive Brief The Food and Drug Administration posted a draft guidance on Monday clarifying how it evaluates real-world data in its decisions to clear or approve medical devices. The draft is an update to a final guidance in 2017 and includes more detail on how the agency assesses the relevance and reliability of real-world data, study design elements and recommendations on documentation for FDA review. An omnibus spending bill passed at the end of 2022 required the FDA to issue a draft guidance on the use of real-world data in premarket submissions. Two years after the public health emergency ended, the law also requires the FDA to specify how many requests for clearance or approval it has received and how many of those applications were approved or denied when real-world evidence was submitted. Dive Insight The 21st Century Cures Act, signed into law in 2016, created a framework for the ...
- Source: drugdu
- 187
- December 21, 2023
Cutting-Edge Lab Automation System Supports High-Volume Needs and Provides Faster Results

A new, innovative automation solution for clinical labs featuring smart technology can boost lab performance and flexibility, reduce turnaround time, and eliminate 80% of manual steps, thereby increasing reliability and minimizing errors to provide quicker lab results Abbott’s (Lake Forest, IL, USA) GLP systems Track is a cutting-edge technology and scalable automation solution that helps laboratories meet high-volume demand and maximize productivity. This system introduces innovative features that boost safety, productivity, and capacity to meet increasing laboratory demands. The flexibility of the GLP systems Track is a standout feature, offering laboratories the ability to tailor the system’s configuration to their specific requirements. A key innovation in this system is the CAR, a smart, self-propelled single sample carrier, which allows samples to move independently, not attached to rigid, fixed mechanized track systems. This innovation minimizes mechanical breakdowns that could halt operations, ensuring continuous functionality and adaptability to the lab’s evolving needs. ...
- Source: drugdu
- 135
- December 21, 2023

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