FDA Approves First Gene Therapy Waskyra for Wiskott-Aldrich Syndrome; Hong Kong Regulators Warn Against Substandard IPO Filings
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Author | Huang Kai
H-share IPOs may tighten.
According to Bloomberg, the Hong Kong Securities and Futures Commission (SFC) and the Hong Kong Stock Exchange jointly sent a letter to sponsors of new listings last week. The letter highlighted that the quality of some submission documents was subpar and concerning, and noted that certain practitioners may be unfamiliar with relevant regulatory requirements or lack sufficient experience in handling new listing applications in Hong Kong. It is unclear how many sponsoring institutions received the letter.
18A is one of the most densely applied fields. Will this have an impact on certain companies?
Gene Therapy Sees New Progress.
Recently, the U.S. FDA announced the approval of Fondazione Telethon's gene therapy Waskyra (etuvetidigene autotemcel) for marketing. It is used to treat patients aged 6 months and above with Wiskott-Aldrich Syndrome (WAS) who carry a WAS gene mutation. Waskyra is suitable for those eligible for hematopoietic stem cell transplantation (HSCT) but unable to find a suitable donor. The press release noted that this is the first gene therapy approved by the FDA for treating patients with Wiskott-Aldrich Syndrome.
In the past day, what hot topics in the pharmaceutical markets at home and abroad are worth paying attention to? Let Amino take you to explore.
/ 01 /
Capital Information
1) The SFC wrote to brokers to be mindful of substandard IPO applications
Recently, according to Bloomberg, the Hong Kong Securities and Futures Commission (SFC) and the Hong Kong Stock Exchange jointly sent a letter to sponsors of new share offerings. The letter highlighted concerns over subpar quality of some submission documents, pointing out that certain practitioners may be unfamiliar with relevant regulatory requirements or lack sufficient experience in handling new listing applications in Hong Kong. It remains unclear how many sponsoring institutions received the letter.
/ 02 /
Pharmaceutical News
1) AstraZeneca's Injectable AZD0292 Receives Clinical Approval
On December 10, according to the CDE website, AstraZeneca's injectable AZD0292 received clinical approval and is intended for the treatment of bronchiectasis.
2) Chuanghe Bio LPM6690176 Capsule Receives Clinical Approval
On December 10, according to the CDE official website, Chuanghe Biotechnology's LPM6690176 capsule received clinical approval. It is proposed to be used in combination with mFOLFOX6 + Bevacizumab or FOLFIRI + Bevacizumab regimen for the first-line treatment of RAS gene mutation-type metastatic colorectal cancer.
/ 03 /
Overseas Pharmaceutical News
1) GSK Abandons Collaboration on Two Synthetic Lethality Mechanism Drugs
Recently, GSK announced the termination of its collaboration with IDEAYA Biosciences on synthetic lethality drugs for solid tumors, returning the clinical programs of two synthetic lethality mechanism drugs, IDE275 and IDE705.
2) FDA Approves Innovative Gene Therapy for Market Launch
Recently, the U.S. FDA announced the approval of Fondazione Telethon's gene therapy Waskyra (etuvetidigene autotemcel) for marketing. It is used to treat patients aged 6 months and above with Wiskott-Aldrich Syndrome (WAS) who carry WAS gene mutations. Waskyra is suitable for those who are eligible for hematopoietic stem cell transplantation (HSCT) but cannot find a suitable donor. The press release noted that this is the first gene therapy approved by the FDA for treating patients with Wiskott-Aldrich Syndrome.
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