BeOne Medicines Ltd 8-K, filed Nov 9, 2020
BeOne Medicines Ltd. (ONC)
8-K
2020-11-09
For: 2020-11-09
View Original
Added on
April 06, 2026
About this 8-K
BeOne Medicines Ltd filed this 8-K on November 9, 2020.
Items reported
- Item 8.01: Other events
- Item 9.01: Financial statements and exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_____________________
Form 8-K
_________________________
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event Reported): November 9, 2020
(Exact Name of Registrant as Specified in Charter)
(State or Other Jurisdiction of Incorporation) | (Commission File Number) | (I.R.S. Employer Identification Number) | ||||||
(Address of Principal Executive Offices) (Zip Code)
+1 (345 ) 949-4123
(Registrant's telephone number, including area code)
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||||||||
| Ordinary Shares, par value $0.0001 per share* | 06160 | The Stock Exchange of Hong Kong Limited | ||||||||||||
*Included in connection with the registration of the American Depositary Shares with the Securities and Exchange Commission. The ordinary shares are not registered or listed for trading in the United States but are listed for trading on The Stock Exchange of Hong Kong Limited.
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o
Item 8.01. Other Events.
On November 9, 2020, BeiGene, Ltd. ("BeiGene") and EUSA Pharma (UK) Limited issued a joint press release announcing that the Biologics License Application (BLA) for QARZIBA®▼ (dinutuximab beta) was accepted by the China National Medical Products Administration (NMPA) and granted priority review. Dinutuximab beta is a targeted immunotherapy approved by the European Medicines Agency (EMA) for the treatment of high-risk neuroblastoma in patients aged 12 months and above who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as patients with history of relapsed or refractory neuroblastoma with or without residual disease. High-risk neuroblastoma is an aggressive neoplasm and the most common childhood solid tumour that originates outside of the brain. Dinutuximab beta is listed in the first batch of New Drugs in Urgent Clinical Need Marketed Overseas by the NMPA. The full text of this press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. | Description | |||||||
| 99.1 | Press release titled "EUSA Pharma and BeiGene Announce Acceptance of a Biologics License Application for QARZIBA®▼ (Dinutuximab Beta) in China" dated November 9, 2020 | |||||||
| 104 | The cover page from this Current Report on Form 8-K, formatted in Inline XBRL | |||||||
Exhibit Index
| Exhibit No. | Description | |||||||
| 99.1 | ||||||||
| 104 | The cover page from this Current Report on Form 8-K, formatted in Inline XBRL | |||||||
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| BEIGENE, LTD. | ||||||||
| Date: November 9, 2020 | By: | /s/ Scott A. Samuels | ||||||
| Name: | Scott A. Samuels | |||||||
| Title: | Senior Vice President, General Counsel | |||||||
EUSA Pharma and BeiGene Announce Acceptance of a Biologics License Application
for QARZIBA®▼ (Dinutuximab Beta) in China
HEMEL HEMPSTEAD, England, BEIJING, China, and CAMBRIDGE, Mass. November 9, 2020 - EUSA Pharma (UK) Limited and BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) today announced that the Biologics License Application (BLA) for QARZIBA®▼ (dinutuximab beta) was accepted by the China National Medical Products Administration (NMPA) and granted priority review. Dinutuximab beta is a targeted immunotherapy approved by the European Medicines Agency (EMA) for the treatment of high-risk neuroblastoma in patients aged 12 months and above who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as patients with history of relapsed or refractory neuroblastoma with or without residual disease. High-risk neuroblastoma is an aggressive neoplasm and the most common childhood solid tumour that originates outside of the brain. Dinutuximab beta is listed in the first batch of New Drugs in Urgent Clinical Need Marketed Overseas by the NMPA.
“Dinutuximab beta represents an important biologic, which is already available to patients with high-risk neuroblastoma in Europe,” commented Xiaobin Wu, Ph.D., General Manager of China and President of BeiGene. “For pediatric patients fighting this disease in China, we are hopeful that dinutuximab beta will soon be available as a new treatment option. Our collaboration with EUSA and the progress thus far demonstrate our joint commitment to bringing high-quality therapies to the people who need them.”
Lee Morley, Chief Executive Officer of EUSA Pharma, said, “This milestone brings us and BeiGene closer to delivering on our promise of bringing innovative cancer and rare disease therapies to patients around the world. We look forward to working with BeiGene and the NMPA to potentially make dinutuximab beta available in China.”
About QARZIBA®▼ (dinutuximab beta)
QARZIBA®▼ is a monoclonal antibody that is specifically directed against the carbohydrate moiety of disialoganglioside 2 (GD2), which is overexpressed on neuroblastoma cells. Dinutuximab beta was approved by the European Commission in 2017 and is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months and above, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as patients with history of relapsed or refractory neuroblastoma, with or without residual disease. Prior to the treatment of relapsed neuroblastoma, any actively progressing disease should be stabilised by other suitable measures. In patients with a history of relapsed/refractory disease and in patients who have not achieved a complete response after first line therapy, dinutuximab beta should be combined with interleukin-2 (IL-2).
About EUSA Pharma
Founded in March 2015, EUSA Pharma is a world-class biopharmaceutical company focused on oncology and rare disease. The company has extensive commercial operations in the United States and Europe, alongside a direct presence in select other markets across the globe. EUSA Pharma is led by an experienced management team with a strong record of building successful pharmaceutical companies and is supported by significant funding raised from leading life science investor EW Healthcare Partners. For more information please visit www.eusapharma.com.
About BeiGene
BeiGene is a global, commercial-stage biotechnology company focused on discovering, developing, manufacturing, and commercializing innovative medicines to improve treatment outcomes and access for patients worldwide. Our 4,700+ employees in China, the United States, Australia, Europe, and elsewhere are committed to expediting the development of a diverse pipeline of novel therapeutics. We currently market two internally discovered oncology products: BTK inhibitor BRUKINSA® (zanubrutinib) in the United States and China, and anti-PD-1 antibody tislelizumab in China. We also market or plan to market in China additional oncology products licensed from Amgen Inc., Celgene Logistics Sàrl, a Bristol Myers Squibb (BMS) company, and EUSA Pharma. To learn more about BeiGene, please visit www.beigene.com and follow us on Twitter at @BeiGeneUSA.
BeiGene Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the potential approval, launch and opportunity of QARZIBA® in China, future development and potential commercialization activities of the products under the agreement with EUSA, and other information that is not historical information. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeiGene's ability to achieve commercial success for its marketed products and drug candidates, if approved; BeiGene's ability to obtain and maintain protection of intellectual property for its technology and drugs; BeiGene's reliance on third parties to conduct drug development, manufacturing and other services; BeiGene’s limited operating history and BeiGene's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates, as well as those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law.
Contacts
EUSA Media
Rebecca Kerr
+44 7909 703627
media@eusapharma.com
BeiGene Investors
Craig West
+1 857-302-5189
ir@beigene.com
BeiGene Media
Liza Heapes
+1 857-302-5663
media@beigene.com