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First patient dosed in Phase 2a trial of AIC468, advancing Asahi Kasei's antiviral program for BK virus.
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MicuRx Pharmaceuticals Signs Exclusive License Agreement for MRX-23 with Milestone Payments Capped at 750 Million US Dollars
MicuRx Pharmaceuticals has signed an exclusive license agreement and a platform technology collaboration agreement with Switzerland's ClearideBio for the MRX-23 project. The nominal cap on milestone payments for the development, registration, and sales of MRX-23 totals 223 million US dollars, while the cap for all platform collaboration projects, if all options are exercised and all milestones are achieved, totals 750 million US dollars. Under the agreement, an upfront payment of 1 million US dollars is payable as agreed after the agreement takes effect and is non-refundable, and near-term development milestone payments are triggered by the first approval of a clinical trial application for the licensed product. Biwin Storage Technology announced that as of September 30, 2026, it had cumulatively repurchased 1,044,700 shares, accounting for 0.22 percent of total share capital, with a total payment of 222 million yuan. The repurchase plan is expected to involve a total amount of 200 million to 250 million yuan. Sino Medical Sciences Technology's coronary balloon dilatation catheter has received approval from Colombia's INVIMA and obtained a medical device registration certificate. Jiangsu Jindike Biotechnology's trivalent influenza vaccine has obtained a drug registration certificate, but the company expects full-year revenue may fall below 100 million yuan and it will not be able to turn a profit. If it triggers the financial delisting risk warning conditions, the Shanghai Stock Exchange will impose a delisting risk warning on the company's shares.
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688108.CG · Regulation · Positive Coronary balloon dilatation catheter received INVIMA approval and medical device registration certificate in Colombia.
688373.CG · Capital · Positive Signed exclusive license and platform collaboration agreement for MRX-23 with up to $750M in milestone payments plus $1M upfront.
688525.CG · Capital · Positive Announced cumulative share repurchases of 1,044,700 shares for 222 million yuan under its buyback plan.
688670.CG · Regulation · Neutral Trivalent influenza vaccine obtained drug registration certificate, but company warns full-year revenue may fall below 100 million yuan and it will not turn a profit, risking delisting warning.
ClearideBio Therapeutics AG · Capital · Positive Signed exclusive license and platform technology collaboration agreement with MicuRx for MRX-23.
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Hainan Haiyao Subsidiary Receives Drug Registration Approval for Isavuconazonium Sulfate for Injection
Hainan Haiyao announced that its wholly owned subsidiary Haikou Pharmaceutical Factory has obtained the Drug Registration Certificate for Isavuconazonium Sulfate for Injection approved and issued by the National Medical Products Administration. The drug is indicated for the treatment of invasive aspergillosis and invasive mucormycosis in adult patients and pediatric patients aged 1 year and older.
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000566.CS · Regulation · Positive Wholly owned subsidiary Haikou Pharmaceutical Factory obtained NMPA Drug Registration Certificate for Isavuconazonium Sulfate for Injection, expanding its approved product portfolio.
海口市制药厂有限公司 · Regulation · Positive Haikou Pharmaceutical Factory received the NMPA Drug Registration Certificate for Isavuconazonium Sulfate for Injection, allowing it to market the drug for invasive aspergillosis and mucormycosis.
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Huayuan Bio-tech Signs New Drug R&D Cooperation Agreement with Guangzhou National Laboratory
Huayuan Bio-tech announced that it has signed a Cooperation Agreement on the 25-Hydroxycholesterol New Drug R&D Project with Guangzhou National Laboratory. The two parties plan to establish a joint venture to advance the research and development, registration, production, and commercialization of 25-hydroxycholesterol and its prodrug-based broad-spectrum antiviral drugs. The joint venture will be led and operated by the company, which will hold no less than 51 percent of the shares. This cooperation marks the company's entry into the innovative drug R&D field, but the project is at an early stage and involves uncertainty.
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SymBio Pharmaceuticals begins talks with MHRA toward conditional early approval of brincidofovir in the UK
SymBio Pharmaceuticals announced that it has begun consultations with the UK Medicines and Healthcare products Regulatory Agency toward obtaining conditional early marketing authorization in the UK for brincidofovir, which targets adenovirus infection following hematopoietic stem cell transplantation. The UK's conditional early marketing authorization scheme is a framework that grants early market access for medicines addressing unmet medical needs such as life-threatening diseases, even before comprehensive clinical data are available, when the confirmed benefits are judged to outweigh the risks; after approval, continued data collection and monitoring of safety and efficacy are mandatory. While advancing the process toward obtaining this approval, the company will also complete its global Phase III clinical trial, currently underway in the United States and Europe, as quickly as possible and focus on establishing evidence of high medical validity. As of September 17, 2026, the trial had enrolled 30 patients, with targets of 69 patients by the end of 2026 and 180 patients by the end of 2027. Brincidofovir is a compound for which the company acquired global rights in September 2019, and it is advancing development centered on three therapeutic areas: post-transplant viral infections, cancer, and neurodegenerative diseases. This matter will have no impact on the company's consolidated earnings forecast for the fiscal year ending December 2026.
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4582.JP · Regulation · Positive SymBio begins MHRA consultations toward conditional early UK marketing authorization for brincidofovir, a regulatory milestone advancing approval.
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RQ Bio Names Gavin Koh Chief Medical Officer Ahead of RQB01 Clinical Push
RQ Bio has appointed Gavin Koh as Chief Medical Officer, strengthening its leadership as the company prepares to advance its lead influenza antibody candidate RQB01 into the clinic. Dr Koh brings 20 years of pharmaceutical drug development and infectious disease experience, having held senior roles at AstraZeneca and GSK, where he led programmes from discovery to registration and launch, including Evusheld during the COVID-19 pandemic. The appointment follows RQ Bio's $115 million, or £85.5 million, Series A financing announced in June 2026, which is supporting the clinical development of RQB01, currently in IND-enabling studies. RQ Bio also named Debra Nevin as Vice President, Head of CMC; Brad Norton as Vice President, Head of Clinical Operations; and Vicky Wheeler as Senior Director, Head of Programme Management. RQB01 is a long-acting antibody product designed to provide potent and broad protection against influenza across an entire season with a single administration for high-risk and immunocompromised populations.
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RQ Bio · Technology · Positive Appointed a Chief Medical Officer and built out clinical leadership as its RQB01 influenza antibody advances toward the clinic
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Moberg Pharma Publishes New Analyses on Terbinafine Susceptibility and MOB-015 in Journal of Fungi
Moberg Pharma AB announced the publication of new analyses demonstrating potent antifungal activity of terbinafine against dermatophytes causing onychomycosis, with mycological cure achieved with MOB-015 across the full range of baseline terbinafine susceptibility, including in patients with reduced in vitro susceptibility. The analyses are based on data from the previously completed North American Phase 3 study evaluating daily treatment with MOB-015 for 48 weeks, and included 506 dermatophyte isolates from onychomycosis patients. Only 3.2% of baseline isolates showed elevated MIC values of at least 0.5 micrograms per milliliter, and among MOB-015-treated patients with evaluable end-of-study results, 74.3% achieved mycological cure, including two of three patients with elevated baseline MIC values. The work was conducted in collaboration with Professor Mahmoud Ghannoum at Case Western Reserve University in Cleveland, Ohio, and the article, titled In Vitro Terbinafine Susceptibility of Dermatophytes and Mycological Cure Outcomes from a Multicenter Phase III Onychomycosis Trial, is published in Journal of Fungi, 2026, 12(10), 739. Amir Tavakkol, CSO of Moberg Pharma, said the results are encouraging, particularly given the increasing attention to antifungal resistance, and that the findings further strengthen the scientific foundation for MOB-015.
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Moberg Pharma AB · Technology · Positive Publication of analyses showing potent terbinafine activity and MOB-015 mycological cure strengthens the scientific foundation for its lead product.