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    BGNE   US07725L1026

BEIGENE, LTD.

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BEIGENE, LTD. : Regulation FD Disclosure, Other Events, Financial Statements and Exhibits (form 8-K)

01/10/2022 | 07:40am EDT

Item 7.01. Regulation FD Disclosure.

As previously announced, the following medicines and/or new indications of BeiGene, Ltd. (the "Company") have been included in the updated National Reimbursement Drug List ("NRDL") in China at the NRDL payment standard set forth below, effective January 1, 2022. For innovative medicines, such as our medicines, the NRDL payment standard is determined through negotiation between the marketing authorization holder ("MAH") and the National Healthcare Security Administration (NHSA), and applied nationwide for the reimbursement of such medicines through China's public medical insurance system.

•Tislelizumab is included in the NRDL in all five of its approved indications - three new indications included since January 2022 and two indications included since March 2021 (NRDL payment standard: RMB 1,450 per 100mg vial):

•For use in combination with pemetrexed and platinum chemotherapy as a first-line treatment in patients with unresectable, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC), with EGFR genomic tumor aberrations negative and ALK genomic tumor negative (approved in June 2021 and included in the NRDL since January 2022);

•For the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with at least one systemic therapy (conditionally approved in June 2021 and included in the NRDL since January 2022);

•For use in combination with paclitaxel and carboplatin as a first-line treatment in patients with unresectable, locally advanced or metastatic squamous NSCLC (approved in January 2021 and included in the NRDL since January 2022);

•For the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy (conditionally approved in April 2020 and included in the NRDL since March 2021); and

•For the treatment of patients with classical Hodgkin's lymphoma (cHL) who have received at least two prior therapies (conditionally approved in December 2019 and included in the NRDL since March 2021).

•BRUKINSA® is included in the NRDL in all three of its approved indications - one new indication since January 2022 and two indications since March 2021 (NRDL payment standard: RMB 85 per 80mg capsule (64 capsules per bottle)):

•For the treatment of adult patients with Waldenström's macroglobulinemia (WM) who have received at least one prior therapy (conditionally approved in June 2021 and included in the NRDL since January 2022);

•For the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy (conditionally approved in June 2020 and included in the NRDL since January 2022); and

•For the treatment of adult patients with chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL) who have received at least one prior therapy (conditionally approved in June 2020 and included in the NRDL since March 2021).

•Pamiparib is included in the NRDL since January 2022 in its approved indication (NRDL payment standard: RMB 53.60 per 20mg capsule (60 capsules per bottle)):

•For the treatment of patients with germline BRCA (gBRCA) mutation-associated recurrent advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more lines of chemotherapy (conditionally approved in May 2021 and included in the NRDL since January 2022).

Item 8.01. Other Events.

On January 6, 2022, the Company issued a press release announcing that the China National Medical Products Administration (NMPA) has approved BeiGene's anti-PD-1 antibody tislelizumab as a second- or third-line treatment for patients with locally advanced or metastatic non-small cell lung cancer. A copy of this press release is attached hereto as Exhibit 99.1, and is incorporated herein by reference.

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Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.

   Exhibit No.            Description

       99.1               Press Release titled "China NMPA Approves Tislelizumab as Second- or
                          Third-Line Treatment for Patients with Locally Advanced or Metastatic
                          Non-Small Cell Lung Cancer", issued by BeiGene, Ltd. on January 6, 2022.

       104                The cover page from this Current Report on Form 8-K, formatted in Inline
                          XBRL




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