Chinese Innovative Drug Enters Japanese Market; Junshi Taihe's Stock Plummets Nearly 60% in Single Day
Haihe Biopharma
Developer of Innovative Anti-Tumor Drugs
METiS TechBio
AI-Driven Drug Formulation Developer
Chinese-Innovative Drugs Enter Japanese Market.
On June 24, HaiHe Biopharma Co., Ltd announced that its MET inhibitor, Glumetinib, had received marketing approval from Japan's Ministry of Health, Labour and Welfare. This marks the first product directly marketed by a Chinese company in Japan, rather than through licensing transfer.
Harrowing Plunge in Stock Prices of Hong Kong's 18A Companies.
Today, the 18A company JunShengTai Pharmaceuticals listed on the Hong Kong Stock Exchange plummeted at the opening bell, with the maximum intraday drop exceeding 61% at one point, and the final closing decline reaching 57.66%.
The AI pharmaceuticals sector continues to attract significant capital investment.
Recently, METiS TechBio announced the completion of its $100 million Series C financing. The proceeds from this round will mainly be used to advance the construction of its AI + drug delivery platform and the development of its self-developed product pipeline.
In the past day, what hotspots in the pharmaceutical markets at home and abroad are worth paying attention to? Let Amino take you to explore.
/ 01 /
Capital Information
1) The stock price of JunShengTai Pharmaceuticals plummeted nearly 60% in a single day.
On June 24, JunShengTai Pharmaceuticals, a Hong Kong Stock Exchange 18A company, opened with a decline, experiencing an intraday drop of over 61% at its worst, and ultimately closing with a 57.66% loss.
2) METiS TechBio Completes $100 Million Series C Financing
Recently, METiS TechBio announced the completion of a $100 million Series C financing round. The funds from this round will primarily be used to further advance the development of the AI + drug delivery platform and the company’s self-developed pipeline.
/ 02 /
Pharmaceuticals and Medical Devices Updates
1) Ningdan New Drug Injection Y-3 Approved for Clinical Trials
On June 24, according to the CDE official website, Ningdan New Drug's injectable Y-3 was approved for clinical trials, with plans to conduct research on the treatment of acute ischemic stroke.
2) Yuhong Pharmaceutical's YH001 Capsule Approved for Clinical Trials
On June 24, according to the CDE official website, YuHong Pharmaceutical's YH001 capsule has been approved for clinical trials, aiming to conduct research on the treatment of vitiligo.
3) China Resources Tianqing's TQB3702 tablet approved for clinical trials
On June 24, according to the CDE official website, Zhengda Tianqing's TQB3702 tablet was approved for clinical trials, intended for use in chronic spontaneous urticaria.
4) Staidson STSP-0902 Injection Approved for Clinical Trials
On June 24, according to the CDE official website, Staidson's STSP-0902 injection has been approved for clinical use to treat oligoasthenospermia.
5) LN2227 Approved for Clinical Trials in the New Era
On June 24, according to the CDE official website, a new era LN2227 has been approved for clinical use in adult patients undergoing elective hip or knee replacement surgery to prevent venous thromboembolic events (VTE).
6) SGB-9768 Injection from Shengyin Biotech Approved for Clinical Trials
On June 24, according to the CDE official website, SGB-9768 Injection from Shengyi Biotech was approved for clinical trials. It is intended for treating complement-mediated kidney diseases, including adult IgA nephropathy, C3 glomerulopathy, and immune complex-mediated membranoproliferative glomerulonephritis.
7) Bayer's BAY 3283142 Hydrochloride Tablets Approved for Clinical Trials
On June 24, according to the CDE official website, Bayer's BAY 3283142 Hydrochloride Tablets were approved for clinical trials, intended for the treatment of chronic kidney disease.
8) FureBio's FL115 Injection Approved for Clinical Trials
On June 24, according to the CDE official website, Fuerong Bio's FL115 injection has been approved for clinical trials, intended for monotherapy or combined with BCG intravesical instillation to treat non-muscle-invasive bladder cancer.
9) Novo Nordisk's ultra-long-acting insulin approved
On June 24, according to the NMPA website, Novo Nordisk's Icodec insulin injection was approved for marketing in China for the treatment of adult type 2 diabetes. Public information indicates that this is a new type of basal insulin analog designed to meet a full week's basal insulin needs with a once-weekly subcutaneous injection.
10) J&J's Long-Acting Schizophrenia Treatment Approved
On June 24, Johnson & Johnson announced that its long-acting injectable drug, Sustenna, administered once every six months, has recently received marketing authorization approval from the National Medical Products Administration (NMPA) for adult patients with schizophrenia who have been adequately treated with Paliperidone Palmitate Injection (3M) for at least three months.
11) Haisco's Long-Acting DPP-4 Inhibitor Approved for Marketing
On June 24, according to the NMPA website, Haisco's long-acting dipeptidyl peptidase-4 (DPP-4) inhibitor Cogrelitin (HSK7653) was approved for marketing in China, indicated for the treatment of type 2 diabetes.
12) Hengrui Medicine Announces Latest Results for GLP-1R/GIPR Agonist Weight Loss Indication
On June 23, Hengrui Medicine announced the Phase II study results of HRS9531, a glucagon-like peptide-1 receptor/glucagon receptor (GLP-1R/GIPR) agonist, for the treatment of obese adult patients without diabetes. The results showed that after 24 weeks of treatment, the weight of patients in the 1.0mg, 3.0mg, 4.5mg, and 6.0mg groups decreased by 5.4%, 13.4%, 14.0%, and 16.8%, respectively, compared to 0.1% in the placebo group.
13) Danqing Pharmaceuticals' PARG Inhibitor Approved for Clinical Trials by FDA
On June 24, Danqing Pharmaceuticals announced that the FDA approved the IND application for PARG inhibitor DAT-2645 on June 22.
14) Hanyu Pharmaceutical's Liraglutide Injection Receives Tentative Approval from U.S. FDA
On June 24, Hanyu Pharmaceutical announced that its Liraglutide Injection had received tentative approval from the U.S. FDA. Tentative approval means that the FDA has completed all review requirements for the generic drug, and the drug has been reviewed to meet the standards for quality, safety, and efficacy required for marketing in the United States. However, due to unexpired patents and/or exclusivity rights, this is a form of approval granted before the resolution of patent or exclusivity issues. Only after these issues are resolved can the U.S. FDA grant qualification for sales in the U.S. end market.
15) Ru Jian Pharmaceutical's NouvNeu001 Receives FDA Approval for Clinical Trials
On June 24, Ruijian Pharmaceutical announced that NouvNeu001, a universal cell therapy product based on chemical induction, received FDA approval for clinical trials and is planned to be studied for the treatment of Parkinson's disease.
16) HaiHe Biopharma's MET Inhibitor Approved in Japan
On June 24, HaiHe Biopharma Co., Ltd announced that the MET inhibitor Glumetinib has been approved for marketing by Japan's Ministry of Health, Labour and Welfare. This is the first product independently developed and launched in Japan by a Chinese company (without licensing transfer).
/ 03 /
Overseas Pharmaceutical News
1) ResMed falls nearly 10% in pre-market trading
On June 24, U.S. medical device company ResMed fell 9.74% in pre-market trading, as its competitor Eli Lilly's drug Zepbound helped 52% of patients resolve sleep apnea issues in trials.
2) argenx's New Indication for Efgartigimod Approved
Recently, argenx announced that the U.S. FDA has approved the expanded indication of Vyvgart Hytrulo for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP).
Text by Huang Kai
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