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Jinghua Pharmaceutical's Ji Desheng Snake Pill Gains Clinical Trial Approval for New Shingles Indication
Jinghua Pharmaceutical announced on the evening of October 11 that it has received a Drug Clinical Trial Approval Notice issued by the National Medical Products Administration. The application to conduct a clinical trial for its Ji Desheng Snake Pill, adding the indication of shingles, specifically the liver-gallbladder damp-heat syndrome type, has been approved. The announcement shows that the clinical trial application meets the relevant requirements for drug registration, and the National Medical Products Administration has agreed to allow the clinical trial of Ji Desheng Snake Pill for shingles, the liver-gallbladder damp-heat syndrome type, to proceed on the basis of further improving the clinical trial protocol.
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002349.CS · Technology · Positive NMPA approved clinical trial for Ji Desheng Snake Pill's new shingles indication, advancing its R&D pipeline.
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Colombia4
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.
China▲2
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.
Japan▲
Asahi Kasei Therapeutics Doses First Patient in Phase 2a Trial of AIC468 for BK Virus
Asahi Kasei Therapeutics, the global specialty pharmaceutical business of Tokyo-based Asahi Kasei, announced that the first patient has been dosed in a randomized Phase 2a clinical trial evaluating AIC468, a novel antiviral antisense oligonucleotide, in adult kidney transplant recipients with BK virus infection. The trial, registered as NCT07503561, is a randomized, double-blind, placebo-controlled study and forms part of a larger Phase 2/3 program designed to assess safety, tolerability, and pharmacokinetic profile across multiple dose levels, measured by the frequency and severity of treatment-emergent adverse events. Progression into Phase 2a was supported by favorable Phase 1 safety, tolerability, and pharmacokinetic data, and the investigational program was developed by Aicuris Anti-infective Cures AG, which is now part of Asahi Kasei Therapeutics. Carl Kraus, Chief Medical Officer of Asahi Kasei Therapeutics, said BK virus reactivation remains a major complication for kidney transplant recipients that can lead to graft dysfunction and BK nephropathy, and that dosing the first patient represents an important step toward a targeted antiviral therapy for a community with no approved treatment options. BK virus-associated nephropathy affects up to 10% of kidney transplant recipients and can result in graft loss, while current management relies on reducing immunosuppressive therapy, which increases the risk of graft rejection.
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3407.JP · Technology · Positive First patient dosed in Phase 2a trial of AIC468, advancing Asahi Kasei's antiviral program for BK virus.
China▲
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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United States▲
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.