Anti-PD-1 monoclonal antibody Puyouheng™ (HX-008, Pucotenlimab injection) Co-developed by LEPU BIOPHARMA and HANX BIOPHARMACEUTICALS was approved for marketing in China by NMPA

HANGZHOU,China,July 25,2022 -- Anti-PD-1 monoclonal antibody – PuyouhengTM (HX-008,pucotenlimab injection),was conditionally approved by the National Medical Products Administration (NMPA) for marketing in China to treat patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) advanced solid tumors,specifically:

Patients with advanced colorectal cancers have progressed following previous treatment with a fluoropyrimidine,oxaliplatin and irinotecan;

Patients with other advanced solid tumors that have progressed following at least previous first-line therapy with no satisfactory alternative treatment options.

The approval is based on a multi-center,open-label,phase II clinical study with a primary study endpoint of the objective response rate (ORR) assessed by the Independent Review Committee (IRC) according to the RECIST1.1. As of December 4,2021,a total of 100 patients with histologically confirmed advanced solid tumors that are identified as having MSI-H/dMMR by the central Laboratory were enrolled in the study. They were given 200 mg of pucotenlimab by intravenous drip every 3 weeks (Q3W). The median follow-up duration for the ITT population was 22.5 months. And the ORR for the ITT population was 49.0% (95% CI: 38.86%,59.20%),with 9 cases of complete response (CR) and 40 cases of partial response (PR). In the subgroup of patients with colorectal cancers who had failed previous triplet therapy (a fluoropyrimidine,oxaliplatin,and irinotecan),the ORR was 50.0% (95% CI: 31.30%,68.70%). The results of the study showed that pucotenlimab monotherapy was safe and effective in patients with unresectable or metastatic MSI-H/dMMR advanced solid tumors who have failed previous standard therapy. The expected clinical endpoints were achieved,indicating that patients can benefit significantly from the therapy. The results of the clinical study were first published at the 2021 American Society of Clinical Oncology (ASCO) annual meeting.

"We are thrilled to see the approval of pucotenlimab,which validates our years of collaboration with Lepu Biopharma",said Dr. Faming Zhang,Chairman of Hanx Biopharmaceuticals,Inc.,"I'm very glad to see the first indication of pucotenlimab was approved in China.The clinical research data of pucotenlimab for MSI-H/ dMMR solid tumors is outstanding and the approval brings new hope to better meet the demands of clinical treatment.Pucotenlimab is the first product launched by Lepu Biopharma as well as a significant milestone in the company's evolution towards Biopharma",commended by Dr. Sui Ziye,CEO of Lepu Biopharma.

About Puyouheng (HX-008,pucotenlimab injection)

Puyouheng (pucotenlimab injection) is a humanized IgG4 monoclonal antibody against human PD-1 discovered by HanX Biopharmaceuticals,It can bind to PD-1 with high affinity to restore the ability of immune cells to kill cancer cells by blocking the binding of PD-1 to its ligands PD-L1 and PD-L2. Puyouheng (pucotenlimab injection) adopts an innovative molecular design to prolong its half-life,showing strong clinical anti-tumor activity and good safety. The innovative use of antibody engineering technology to introduce triple mutations in the Fc region improves the binding affinity of FcRn,thereby prolonging the drug's half-life significantly,showing its promising clinical efficacy and drug compliance in patients [5]. Compared with all rival anti-PD-1 antibodies that have been marketed or entered phase III clinical trials,the mean half-life of Puyouheng (pucotenlimab injection) is 21.8 days (single dosing) and 38.2 days (steady-state). In addition,the prolonged half-life does not cause additional adverse events,indicating the excellent clinical efficacy of the drug.

About HANX BIOPHARMACEUTICALS

Hanx Biopharmaceutical Co.,Ltd. is a global biopharmaceutical company that develops innovative immune-oncology antibody drugs. It brings together well-known experts,from both China and United States,from early discovery,process development,business development,to clinical research. The company leverages expertise to develop patented high-affinity long half-life antibody screening and tumor-immune cell specific tumor-targeting antibody GPSmAb technology platforms. The company develops innovative treatments to address significant unmet medical needs,and to help patients around the world. The company aims to accomplish goal through in-house research development as well as external global collaborations.

About LEPU BIOPHARMA (2157.HK)

LEPU BIOPHARMA is committed to innovation,focusing on the discovery,development and commercialization of first-in-class and best-in-class drug candidates in targeted anti-tumor therapy and immunotherapy drugs in China and the US. The company's mission is to develop the safest,most effective,and most accessible drugs for patients to improve their quality of life and fill the huge demand gap in the medical system. The company attaches great importance to the continuous construction of its commercialization capabilities,and strives to achieve a strong transformation from core technologies to finished drugs as well as the goal of industrialization. At present,the product pipeline of LEPU BIOPHARMA covers three major areas,namely immunotherapies,ADC targeted therapies and oncolytic virus drugs,including 1 commercially marketing drug and 7 drug candidates at the clinical stage (5 of which are ADC drugs) and the combination therapies of multiple major drug candidates at the clinical stage. The company houses the leading ADC drug candidate pipeline in China.

References:

[1] Gandhi JS,Goswami M,Sharma A,et al. Clinical impact of mismatch repair protein testing on outcome of early staged colorectal carcinomas[J]. J Gastrointest Cancer. 2017 Jun 5.

[2] Sclafani F. PD-1 inhibition in metastatic dMMR/MSI-H colorectal cancer[J]. Lancet Oncol.2017 Sep;18(9):1141-1142.

[3] Sargent DJ,Marsoni S,Monges G,T,et al. Defective mismatch repair as a predictive marker for lack of efficacy of fluorouracil-based adjuvant therapy in colon cancer[J]. J Clin Oncol. 2010 Jul 10;28(20):3219-26.

[4] Marcus L,Lemery SJ,Keegan P,Pazdur R. FDA Approval Summary: Pembrolizumab for the Treatment of Microsatellite Instability-High Solid Tumors[J]. Clin Cancer Res. 2019;25(13):3753-3758.

[5] Zhang JB,Huang Y,Xi G,and Zhang F. HX008: a humanized PD-1 blocking antibody with potent antitumor activity and superior pharmacologic properties,MABS 2020,12 (1): e1724751 (12 pages) https://doi.org/10.1080/19420862.2020:1724751

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