Baiji Shenzhou Q3 performance: Revenue: 50.14 million US dollars; R & D Investment: 236.97 million US dollars

On November 13, 2019, Baiji Shenzhou company today announced its recent business highlights, expected milestones, and financial results for the third quarter of 2019 Mr Ou Lei Qiang, founder, CEO and chairman of Baiji Shenzhou, said: "recently, we announced the establishment of a transformational cooperation with Amgen, which is expected to be completed in early 2020 At that time, we will start to implement the commercialization and development plan for three commercial stage drugs and 20 candidate drugs of Amgen in China We believe that this cooperation has further consolidated our position as the preferred partner for commercialization and development in China, all of which is due to our strong commitment to talent, global impact, and patient, compliance and quality Over the past quarter, we have continued to prepare for planned product launches in the US and China Looking forward to the important events of the company before the end of this year and 2020, there are as many as 10 ongoing phase 3 or potential registered clinical trial plans to release data, and there are also two planned companies to independently develop products for commercial listing " Zebutini, a recent business highlights and expected milestone clinical project, is a small molecule Btk inhibitor under development designed to maximize the share of BTK and minimize the Miss effect Announced that the US Food and Drug Administration (FDA) has been granted the priority review qualification for the new drug marketing application (NDA) for the treatment of relapsed / refractory (R / R) cell lymphoma (MCL) patients by rizapotinib, and the PDUFA date is February 27, 2020; launched the following clinical trials: A global phase 3 clinical trial of zebutinib combined with rituximab compared with bendamoxetine combined with rituximab in the treatment of MCL patients who have not been treated before and are not suitable for stem cell transplantation (clinical trials Gov Registration No.: nct04002297); A global phase 2 clinical trial for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously been treated and are intolerant to ibotinib (clinicaltrials.gov registration number: nct04116437) Zebutini expected milestone At the 61st annual meeting of the American Society of Hematology (ash) (held in Orlando, USA, on December 7-10, 2019), the preliminary data of chromosomal 17p deletion group in the seqooia3 phase clinical trial of zebotinib versus bendamostine combined with rituximab for the treatment of previously untreated patients with CLL / SLL and the update number of phase 1 / 2 clinical trial for the treatment of R / RCLL / SLL were published According to the updated results of clinical trials of zebutinib combined with tirelizumab in the treatment of B-cell malignant lymphomas, the main data of Aspen global phase 3 clinical trials of zebutinib compared with ibuprofen in the treatment of patients with megaglobulinemia of Fahrenheit (WM) were published in 2019; In the United States, the company has obtained the approval of FDA for new drug marketing for R / rmcl patients At present, the date of PDUFA is February 27, 2020 In the first half of 2020, it has obtained the approval of new drug marketing for R / rmcl patients and R / RCLL / SLL patients in China In the first half of 2020, it has submitted the application for new indications (SNDA) for WM patients in China; The main data of seqoia clinical trial was published as early as 2020; the patients who completed the alpine3 clinical trial of zebotinib compared with ibotinib for R / RCLL / SLL patients in 2019 or early 2020, and the patients who completed the Magnolia 2 clinical trial of zebotinib for R / R marginal zone lymphoma (MZL) patients were enrolled Tirelizumab, a human IgG4 monoclonal antibody designed to avoid binding to Fc receptor in macrophages, was used to complete the global phase 3 clinical trial (clinical trials Gov Registration No.: nct03412773) of tirelizumab compared with solafeni in the treatment of first-line unresectable liver cancer (HCC); The data of the second phase clinical trial (clinical trials Gov Registration No.: nct04004221) of tirelizumab for the treatment of locally advanced or metastatic urothelial cancer (UC) in China and South Korea were published at the 2019 conference of the European Society of Oncology (ESMO); the following clinical data were published at the 22nd annual conference of the Chinese society of Clinical Oncology (CSCO): The results of a phase 2 clinical trial (clinical trials Gov Registration No.: nct03432598) of tirelizumab combined with chemotherapy for first-line lung cancer patients in China, and the updated results of a phase 2 clinical trial (clinical trials Gov Registration No.: nct03469557) of tirelizumab combined with chemotherapy for ESCC patients in China; A 1 / 2-phase clinical trial of tirelizumab in the treatment of advanced solid tumor patients was carried out in China (Clinical Trial Registration No.: ctr20160872) Tirelizumab is expected to be a milestone event in 2019 when it will be approved for the market of new drugs for the treatment of R / R classic Hodgkin's lymphoma (CHL) patients in China, and in 2020 when it will be approved for the market of new indications for the treatment of locally advanced or metastatic UC patients in China; Communicate with the drug regulatory agency on the preliminary results of the global phase 2 clinical trials (clinical trials Gov Registration No.: nct03419897) of tirelizumab for the treatment of second and third line HCC patients in 2019 or early 2020; In 2020, the main data of the phase 3 clinical trial (clinical trials Gov Registration No.: nct03594747) of tirelizumab combined with chemotherapy in the treatment of patients with first-line squamous non-small cell lung cancer (NSCLC) were published; In 2020, the main data of the phase 3 clinical trial (clinical trials Gov Registration No.: nct03663205) of tirelizumab combined with chemotherapy for the treatment of first-line non squamous NSCLC patients were published; Phase 3 clinical trials (clinical trials Gov registration number: nct03358875) for the treatment of second-line NSCLC patients were completed in 2019 or early 2020; phase 3 clinical trials (clinical trials Gov registration number: nct03430843) for the treatment of second-line advanced ESCC patients were completed in the first half of 2020 Of patients Pamiparib, a small molecule PARP inhibitor under research, published the following clinical data at the ESMO conference: the updated results of phase 1b clinical trial (clinical trials Gov Registration No.: nct03150810) of pamiparb combined with low-dose temozolomide in the treatment of locally advanced or metastatic solid tumor patients; Updated results of dose escalation / expansion of pamiparib in phase 1 clinical trials (clinical trials Gov Registration No.: nct02361723) for patients with advanced solid tumors Pamiparib anticipates that the milestone event will be communicated with the drug regulatory agency in 2020 on the preliminary results of the key phase 2 clinical trial (clinical trials Gov Registration No.: nct03333915) of pamiparb for the treatment of ovarian cancer (OC) patients who have received previous treatment; In 2020, the data of three phase clinical trials (clinical trials Gov Registration No.: nct03519230) of pamiparib for maintenance treatment of platinum sensitive recurrent OC patients were published; In 2020, a global phase 1 clinical trial (clinical trials Gov registration number: nct02361723) of pamiparib for the treatment of OC patients was released, and the updated data of phase 1 clinical trial (clinical trials Gov registration number: nct02660034) of pamiparib combined with tirelizumab for the treatment of advanced solid tumor patients was submitted in China in 2020 Lifirafenib (bgb-283), a dimer inhibitor in research combined with springworks therapeutics, launched a clinical trial of lifirafenib combined with MEK inhibitor mirdematinib (pd-0325901) for the treatment of advanced or refractory solid tumor patients (clinical trials Gov Registration No.: nct03905148) Bgb-a1217, a tigit monoclonal antibody in research, started a phase 1A / 1b clinical trial (clinical trials Gov Registration No.: nct04047862) in China and Australia to study the safety, tolerance, pharmacokinetics and preliminary anti-tumor activity of the combination of bgb-a1217 and tirelizumab for the treatment of patients with advanced solid tumors Bgb-11417, a small molecule Bcl-2 inhibitor under research, has completed the pre clinical research of bgb-11417 and the research supporting the application for new drug research (ind), showing strong activity and high selectivity in the anti apoptotic protein bcl-2 Bgb-11417 is expected to launch a phase 1 clinical study in Australia and the United States in the first half of 2020 to assess the safety, tolerability, pharmacokinetics and preliminary antitumor activity of bgb-11417 in mature B-cell malignancies The production base of biological drugs in Guangzhou, China completed the construction of phase I project and the confirmation and verification of production equipment, and officially started operation Commercial operation in China, the use of rifamycin ® in the treatment of R / R multiple myeloma patients has been officially included in the national health insurance catalog (nrdl); in China, the preparation for the product launch of tirelizumab in the treatment of R / rchl patients plan is continuing, and the training of medical sales personnel has been completed; In the United States, medical sales personnel have been recruited to actively prepare for the launch of the planned zebutinib for the treatment of R / rmcl patients The company announced the establishment of a global cancer strategic partnership with Amgen It has developed and commercialized in China Amgen (xgeva ®) desurmab injection, kyprolis (kafzomib for injection) and blincyto (bilintomolobib for injection) At the same time, it has jointly developed 20 Amgen anti-tumor pipeline drugs Amgen has agreed to buy about $2.7 billion in Baiji Shenzhou shares The transaction is expected to be completed in early 2020 if it meets the following conditions: baichi Shenzhou obtains the approval of the majority shareholders in accordance with the listing provisions of the stock exchange of Hong Kong, the expiration or termination of the waiting period in accordance with the applicable anti-monopoly law, and other specific delivery conditions Shareholders holding about 40% of the shares of the company have agreed to vote in favor of the transaction; announced a global license agreement with seattlegenetics on an advanced preclinical tumor candidate drug, and baichi obtained development and commercialization rights in Asia (except Japan), the Americas (the United States, Canada and Latin American countries) and other regions of the world outside Europe The candidate drug, which uses antibody technology patented by seattlegenetics, is expected to enter clinical trials in the first half of 2020 As of September 30, 2019, the cash, cash equivalents, restricted funds and short-term investments held by the company in the third quarter of 2019 were US $1.28 billion, compared with us $1.56 billion held on June 30, 2019 and US $1.81 billion held on December 31, 2018 For the third quarter ended September 30, 2019, $265.1 million was used in operating activities, compared with $132.1 million in operating activities for the same period in 2018 The increase is mainly due to the increasing operating expenses to support the preparation for the release of future drug candidates in the United States and China, the continuous development of internal and authorized drug candidates, and the overall scale expansion of the company In the third quarter ended September 30, 2019, capital expenditure was US $30.87 million, mainly due to the construction of Guangzhou biological preparation production base Revenue for the third quarter ended September 30, 2019 was $50.14 million, compared with $54.2 million for the same period in 2018 The decrease in revenue is mainly attributable to the company in the second quarter of 2019