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HUTCHMED (China) Limited Secures NMPA Approval for ORPATHYS - SEC Form 6-K Report

$HCM
Form 6-K
Filed on: 2025-01-14
Source
HUTCHMED (China) Limited Secures NMPA Approval for ORPATHYS - SEC Form 6-K Report

Here are the key insights extracted from the provided section of the financial report:

  1. Document Type & Submission:
  • The document is a Form 6-K, filed with the SEC by HUTCHMED (China) Limited.
  • Filing date: January 14, 2025.
  1. Company Information:
  • Name: HUTCHMED (China) Limited.
  • Address: 48th Floor, Cheung Kong Center, 2 Queen's Road Central, Hong Kong.
  • Commission File Number: 001-37710.
  1. Regulatory Compliance:
  • The filing is made under the Securities Exchange Act of 1934, specifically pursuant to Rules 13a-16 or 15d-16.
  1. Exhibit Details:
  • The report includes Exhibit 99.1, which is a press release announcing that HUTCHMED has received full approval from the National Medical Products Administration (NMPA) in China for ORPATHYS (savolitinib).
  • The approval is for treating patients with locally advanced or metastatic MET exon 14 non-small cell lung cancer (NSCLC).
  1. Signature:
  • The report is signed by Johnny Cheng, who is the Chief Financial Officer of HUTCHMED.
  1. Date of Signature: January 14, 2025.

Summary:

HUTCHMED (China) Limited has filed a Form 6-K with the SEC, reporting the full approval of their drug ORPATHYS for specific cancer treatment in China, an important regulatory milestone that could positively impact their market position and revenue streams. The filing is duly signed by the CFO, indicating compliance with regulatory requirements.