Recently, InnoCare announced that the Phase II clinical study of ICP-488, a novel self-developed tyrosine kinase 2 (TYK2) inhibitor, in the treatment of moderate to severe plaque psoriasis, met the primary endpoint. In patients treated for 12 weeks, ICP-488 demonstrated superior efficacy and safety. ICP-488 met multiple efficacy endpoints in the once-in-a-day 6 mg and once-daily 9 mg dose groups, including Psoriasis Area and Severity Index (PASI) 75, PASI 90, PASI 100 (PASI score improvement from baseline ≥75%, ≥90%, and ≥100%), and static Clinician’s Global Assessment (sPGA) 0/1 (i.e., complete or basic clearance of lesions). The response rate of PASI 75 was 77.3% and 78.6%, respectively, in the once-daily 6 mg and 9 mg dose groups, compared with 11.6% in the placebo group (p<0.0001). The response rate of PASI 90 in the two dose groups reached 36.4% and 50.0%, respectively, compared with 0% in the placebo group (p<0.0001); The response ...
Chi-Med (China) Limited (“HUTCHMED”) today announced that Elunate ® (fruquintinib) has been added to the Drug Formulary of the Hong Kong Hospital Authority (“HA”) in the category of “Specialty Drugs”. Patients who are prescribed the new drug for specific clinical applications in public hospitals or clinics are only required to pay the standard fee. Elunate ® received approval from the Pharmacy and Poisons Board of Hong Kong in January 2024 for the treatment of adult patients with metastatic colorectal cancer who have been treated. The first innovative anti-oncology drug to be directly included in the HA’s Drug Formulary category, and the first new drug to be approved under the “1” mechanism of the HA’s Drug Formulary, which was quickly included in the Drug Matrix and the “1” mechanism, helping patients accelerate access to important treatment options. Elunate ® is the first oral targeted therapy approved in Hong Kong for the ...
Recently, ShiraTronics, an innovative medical device company for migraine, announced the completion of a $66 million (approximately RMB 460 million) Series B financing to support its innovative migraine treatment system. This round of financing was led by new investor Norwest Venture Partners, and other new investors included Seroba, OSF Ventures, Global BioAccess Fund, and an undisclosed strategic investor. In addition, some existing investors such as U.S. Venture Partners, Amzak Health, Treo Ventures, and Aperture Venture Partners also participated in this round of financing. ShiraTronics, located in Minneapolis, Minnesota, is a clinical-stage medical device company focused on developing neurostimulation therapies for chronic migraine patients. It is committed to improving the lives of chronic migraine patients and received the FDA breakthrough device designation in 2021. The name of the disease migraine is not unfamiliar, and it is often heard in life, so the migraine market is also quite extensive worldwide. According to ...
Zantac was originally a popular heartburn drug. From being popular all over the world to being withdrawn from the market due to carcinogenic risks, the years-long litigation disputes can be regarded as a slow and bumpy roller coaster for patients and manufacturers. This storm can be traced back to June 2019. At that time, Valisure discovered and informed the FDA during routine batch testing that the active ingredient ranitidine in Zantac would degrade under certain conditions and produce N-nitrosodimethylamine (NDMA), a Class 2A carcinogen. In September of the same year, Valisure formally submitted a citizen petition to the FDA, requesting the recall of all products containing ranitidine. Since then, Zantac has been deeply involved in the carcinogenic storm. The FDA further found that the higher the storage temperature or the longer the storage time of Zantac, the higher the risk of exceeding the standard of NDMA, which was originally very ...
More than 20 years ago, research on rare diseases and the treatment of rare diseases were very rare in the medical community. The small market size of rare diseases and the huge difficulty in research and development have made pharmaceutical companies shy away from this field. In the past 25 years, BioMarin has launched eight rare disease drugs with strong R&D capabilities. Arguably, this record is unmatched by few companies in the biotech industry. However, with the failure of the commercialization of its highly-anticipated hemophilia A gene therapy, Roctavian, a strategic review began. Since the beginning of this year, BioMarin has been in turmoil. Over the past nine months, there have been layoffs, executive restructuring, spending cuts, and research projects on hold. With the reshuffle of the business structure and the arrival of new competition, it remains to be seen when BioMarin will be able to get out of this ...
Drugdu.com expert’s response: When importing and exporting goods through customs, various aspects need to be taken into consideration to ensure smooth customs clearance and compliance with relevant regulations. Here are some key considerations: Ⅰ. Documentation Preparation Complete and Accurate Documentation: Import-export enterprises must prepare complete documents, including bills of lading, invoices, packing lists, contracts, import-export licenses (if required), certificates of origin, inspection and quarantine certificates, etc. These documents must be accurate and in line with customs requirements. Compliant Declaration: Ensure that the declared information for goods is accurate, including commodity names, quantities, values, origins, etc. The declared value should match the actual value to avoid issues arising from over- or under-declaration. Ⅱ. Commodity Classification and Taxation Accurate Classification: Accurate classification of goods is crucial, as it directly determines the Harmonized System (HS) code, which further influences tariff rates and regulatory conditions. Misclassification can lead to unnecessary troubles and losses. Tax ...
On October 9, 2024, Biolase, which occupies the top spot in the world’s dental laser equipment, announced that it has signed an agreement to sell the majority of the company’s assets to rival Sonendo for $14 million. Biolase Company of United States, the world’s leading oral laser expert, has long been committed to the research and development and manufacturing of full-function lasers, with a global laser market share of 70%. However, due to long-term losses, the stock price continued to be depressed, and it was delisted from the Nasdaq in June this year and declared bankruptcy on October 1. The buyer of the acquisition, Sonendo, a dental giant dedicated to root canal treatment devices, sued Biolase in 2023 for a patent dispute, claiming no less than $59 million in damages. This acquisition not only marks the end of an era for the giant Biolase, but also announces the end of ...
On August 30, 2024, the Shanghai Pharmaceutical Affairs Institute issued a document that the information on products related to the centralized procurement of intraocular lenses and sports medicine organized by the state will be released through the portal on September 3, 2024, and will take effect on September 10, 2024. So far, the fourth batch of national procurement has been implemented in all provinces across the country. The “Notice on the Centralized Procurement and Use of Intraocular Lens and Sports Medicine Medical Consumables Organized by the State” issued by Shanghai marks the full implementation of the fourth batch of high-value consumables in China. This policy has had a significant impact on the medical industry, especially on the intraocular lens market. It is reported that 126 companies were selected in this national procurement, involving 30 product categories, and the average price reduction of the selected products was 70%, of which the ...
Source: 21st Century Business Herald Has the cow arrived? The A-share market is booming, don’t miss the opportunity, open an account and layout now>> Recently, there has been a frequent wave of business development (BD) cooperation transactions between Chinese and foreign pharmaceutical companies. On October 9th, Baiaotai announced that it has reached an authorization license, production, supply, and commercialization agreement with Gedeon Richter Plc. for BAT2206 (ustekinumab) injection solution. According to the agreement, Baiaotai will license the exclusive commercial rights of the injection in the EU, UK, Switzerland, Australia, and other European markets to Gedeon Richter Plc for a fee. The amount involved in this transaction includes a down payment of $8.5 million, milestone payments up to a cumulative total of $101.5 million, and revenue sharing based on a double-digit percentage of net sales. In addition to Baiaotai, several Chinese pharmaceutical companies have also recently received positive news regarding BD ...
On October 9th, Johnson&Johnson announced plans to invest over $2 billion (approximately RMB 14.1 billion) in Wilson, North Carolina to build an advanced biopharmaceutical manufacturing facility to support its growing portfolio of biologic therapy products in oncology, immunology, and neuroscience. It is reported that this measure is in line with Johnson&Johnson’s broader strategy of submitting or launching over 70 new therapies and product expansions by the end of the next decade. The new facility will be equipped with cutting-edge technology, which will not only enhance global production capacity, but also provide approximately 420 high skilled full-time positions for the local area. The project will begin construction in the first half of 2025. In August of this year, in order to strengthen its position in the cardiovascular field, Johnson&Johnson announced the acquisition of V-Wave, a company specializing in heart failure treatment technology. Prior to this, Johnson&Johnson acquired for approximately $13.1 billion ...
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