21 Health Daily | Koito Pharmaceutical Osaka Plant Found with Penicillium in Six Locations; Keytruda Achieves OS Endpoint in Neoadjuvant Treatment of Triple-Negative Breast Cancer

Source: 21st Century Business Herald

• Department of Drug Policy and Essential Medicines System Releases the Fifth List of Encouraged R&D and Submission of Pediatric Medicines

  On May 30, the Department of Drug Policy and Essential Medicines System released the "Public Notice on the Proposed List of the Fifth Batch of Encouraged Research and Development for Pediatric Drug Submissions." It showed that, to further implement the requirements of the "Several Opinions on Ensuring Pediatric Drug Use" issued by the former National Health and Family Planning Commission and five other departments, enrich the varieties, dosage forms, and specifications of pediatric drugs, and meet the clinical medication needs in pediatrics, in 2024, the National Health Commission, the Ministry of Industry and Information Technology, and the National Medical Products Administration closely focused on China's pediatric disease spectrum and the R&D and production capabilities of related enterprises. They organized experts from clinical, pharmaceutical, R&D, registration, and other relevant fields to combine the current situation of pediatric drugs that have not yet been registered and marketed within mainland China but are urgently needed clinically. Based on evidence-based principles, they screened and argued to propose the "Proposed List of the Fifth Batch of Encouraged Research and Development for Pediatric Drug Submissions."

  
  

• Gan&Lee Pharmaceuticals Passes EUEMA Pre-Approval GMP Inspection
  On May 29, Gan&Lee Pharmaceuticals announced that it had recently received formal notification from the EMA, stating that the company's manufacturing facilities comply with EU GMP regulations and are now qualified for the commercial production of insulin glargine injection, insulin lispro injection, insulin aspart injection, and prefilled injection pens.
  
  
  
  

• Ribo Life Science's siRNA New Drug Approved for Phase 2 Clinical Trial in Europe

  On May 29, Ribo Life Science announced that its self-developed anti-thrombotic siRNA drug RBD4059 targeting FXI had recently received Phase 2 clinical trial approval from the European Medicines Agency (EMA). This is a randomized, double-blind, placebo-controlled Phase 2 clinical study aimed at evaluating the safety, efficacy, and pharmacokinetics of RBD4059 in patients with stable coronary artery disease. According to the introduction in Ribo Life Science's press release, RBD4059 has the potential for ultra-long-acting anti-thrombotic effects with one injection every six months.

  
  

• Zelgen's JAK/ACVR1 Dual Inhibitor Approved for Phase 2/3 Clinical Trials
  On May 29, Zelgen announced that the company's Gicaxitinib Hydrochloride Tablets (formerly known as Jacktinib Hydrochloride Tablets) for the treatment of non-segmental vitiligo in adolescents aged 12 years and above and adults had been approved by China's NMPA for Phase 2/3 clinical trials. Gicaxitinib Hydrochloride is a novel JAK and ACVR1 dual inhibitor independently developed by Zelgen.
  
  
  
  
• Fulink Technology's PSMA-Targeted RDC Approved for Clinical Use in the U.S.

  On May 30, Fluence Therapeutics announced that its PSMA-targeted radiopharmaceutical 225Ac-FL-020 had received approval from the U.S. FDA for a new drug clinical trial (IND) to treat metastatic castration-resistant prostate cancer (mCRPC).

  According to the press release, Fluorine Link will soon launch the global Phase 1 clinical study of this product.

  
  

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• Capital Market
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• BGI Genomics Co., Ltd.: Some Directors and Executives Plan to Increase Their Shareholdings

  On May 29, BGI Genomics Co., Ltd. announced that some of the company's directors and senior management plan to increase their holdings of the company’s stock within six months from the date of this announcement. The purchases will be made through the Shenzhen Stock Exchange trading system in accordance with relevant laws and regulations (including centralized bidding and block trading methods), with a total amount of no less than RMB 10 million.

  
  

• Hangzhou Puyuan Bio Completes Tens of Millions of Yuan in Pre-A Round Financing

  Recently, Hangzhou Puyuan Biotechnology Co., Ltd., one of the first biopharmaceutical companies in China dedicated to the research and development of live microbial drugs for autoimmune diseases, has successfully completed a Pre-A round of financing worth tens of millions of yuan. This marks the second round of financing following last year's multi-million-yuan angel investment. The round was led by Xinghua Dingli Venture Capital, with West Lake Sci-Tech Investment participating. Puyuan Biotech stated that the funds raised will be used for further functional development and clinical research of its proprietary star strains PM001, PM002, PM005, market development of its self-operated brand Gibson Probiotics, as well as the construction of R&D and production bases.

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• Industry Highlights
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• Kobayashi Pharmaceutical Osaka Plant FoundSix locations with Penicillium

  On May 29, according to media reports, the inspection results of Kobayashi Pharmaceutical's Osaka factory by the Japanese government were announced that afternoon. At Kobayashi Pharmaceutical's factory in Osaka, six locations were found to have Penicillium mold, which is the same type of Penicillium that produces penitrem A as found in its Wakayama factory.

  
  

• Yinming Biologics Announces Research Data for Two New Drugs, Including HPK1 Inhibitor

  On May 29, Aclaris Bio announced that its subsidiary Yufan Bio will present the Phase 1 clinical data of its investigational HPK1 small molecule inhibitor PRJ1-3024 in China and the preclinical data of Cbl-b small molecule inhibitor YF550-C1 at the ASCO Annual Meeting to be held in the United States from May 31 to June 4, 2024, in poster format.

• Illumina Announces Collaborative Research Findings at ASCO Conference

  On May 29, Illumina (NASDAQ: ILMN), the global leader in gene sequencing and chip technology, announced that it will present its latest research findings at the American Society of Clinical Oncology (ASCO) Annual Meeting held in Chicago from May 31 to June 4. Highlights include collaborations with Labcorp (Labcorp) Data from several studies conducted in collaboration with Sarah Cannon Research Institute (SCRI), which further demonstrate the advantages of comprehensive genomic profiling (CGP) over single-gene testing (SGT); and the latest data supporting the development of Illumina’s minimal residual disease (MRD) detection, a product currently being developed in collaboration with large pharmaceutical companies. During the conference, Illumina had 14 research abstracts accepted by the conference.。

• K Drug Neoadjuvant Treatment for Triple-Negative Breast Cancer Reaches OS Endpoint
  May 28Merck announced positive results from the Phase 3 clinical trial KEYNOTE-522.Data show that Keytruda combined with chemotherapy as a preoperative neoadjuvant therapy and simultaneously as a postoperative monotherapy adjuvant treatment achieved the overall survival (OS) endpoint in patients with high-risk early-stage triple-negative breast cancer (TNBC).Compared with chemotherapy as a neoadjuvant therapy, Keytruda is the first immunotherapy regimen that significantly improves OS in this patient population, both as part of a neoadjuvant combination therapy and as a single-agent adjuvant therapy.