Xinda biology's mid-term performance in 2019: total revenue of 350 million yuan, and dabushu's contribution of 330 million yuan

Xinda biopharmaceutical Co., Ltd is a biopharmaceutical company dedicated to the research, development, production and sales of innovative drugs for the treatment of major diseases such as cancer and metabolic diseases The company today announced its interim financial results for the six months ended June 30, 2019 Abstract and recent highlights total revenue of 345.5 million yuan, including 331.6 million yuan contributed by the sale of Dabusu ® (cindilimab injection) Dabusu ® (cindilimab injection) is the first commercial drug of Cinda bio It was approved by the State Drug Administration in December 2018 and began to be sold on March 9, 2019 The gross profit margin is 88.1%, which reflects that the company has the ability to stably produce high-quality Dabusu (cindilimab injection) in the early stage of commercial production Through 20 ongoing clinical trials, dabushu ® (sindilimab injection) continues to extensively promote clinical development plans for a series of cancer indications, including 8 registration trials (3 of which have completed patient recruitment; 3 of phase III and 1 of phase II / III trials have completed the first patient administration) Ibi-303, ibi-305 and ibi-301 have been submitted to the NDA for priority review Ibi-306 (new anti PCSK9 monoclonal antibody) has completed the phase II clinical trial of Chinese hypercholesterolemia patients, and started the phase III clinical trial for the same indication Phase I clinical research of multiple products completed the first patient administration: ibi-188 (New anti-CD47 monoclonal antibody); ibi-302 (first anti VEGF / anti complement double specific fusion protein); ibi-318 (first anti PD-1 / anti PD-L1 double specific antibody); and ibi-101 (new anti OX40 monoclonal antibody) By signing the license agreement of ibi-362 with Lilly company, we will further enhance our product pipeline and expand the disease treatment field of Cinda biology to the field of diabetes Ibi-362 is a new type of oxm3 peptide, which is the best clinical diabetes drug candidate in the world Our second phase production facilities include six 3000 liter stainless steel bioreactors, which have completed the commissioning and validation of GMP, and the total capacity has been increased to 21000 liter Dr Yu Dechao, founder, chairman and President of Cinda bio, said: "in the first half of 2019, Cinda bio reached several major milestones in drug channels and business operations, which pushed the company into a new development journey Our first commercialized drug has been successfully launched, which fully reflects our strong ability from R & D, production to clinical and sales integrated platform, and further proves our strength in transforming excellent R & D ability into commercial success With our excellent platform and in-depth cooperation with Lilly, we have further expanded our product pipeline, established a strong product portfolio composed of 21 innovative drugs, and covered the diabetes field Among them, the clinical progress of many projects is rapid, three biological similar drugs have submitted new drug listing applications and obtained the priority evaluation qualification, three phase III critical clinical trials have completed the patient group, and a number of new bispecific antibody candidate drugs have started phase I clinical trials In addition, our new plant facilities have been successfully verified, and all of the above progress has provided strong support for the implementation of our long-term growth strategy " "Looking forward to the future, we will continue to promote the commercialization of Dabusu ® (sindilimab injection), ensure its smooth progress, and prepare for the subsequent launch of new products," Yu added The vigorous development of China's pharmaceutical industry continues to bring new development opportunities We will continue to promote clinical progress, continue to expand the product pipeline to cover the treatment areas with huge unmet clinical needs, and devote ourselves to the development and commercialization of high-quality drugs, benefiting more people " Financial Summary: the total revenue for the six months ended June 30, 2019 was RMB 345.5 million, including the sales volume of pharmaceutical products of the group's first commercial drug product, dabushu ® (cindilimab injection), since its successful listing in March 2019, which was RMB 331.6 million, and for the six months ended June 30, 2018, which was RMB 4.4 million The successful listing of Dabusu ® (cindilimab injection) has promoted the group's transformation from a R & D-oriented stage to a commercial stage, and has fully exploited the potential of the full cycle platform for product development, exploring, developing, producing and selling innovative drugs in various treatment fields For the six months ended June 30, 2019, the group's gross profit margin reached 88.1%, reflecting the group's ability to stably produce high-quality Dabusu ® (cindilimab injection) in the early stage of commercial production The R & D expenditure for the six months ended June 30, 2019 increased by RMB 250.7 million to RMB 670.7 million, and for the six months ended June 30, 2018, it was RMB 420.0 million, mainly due to (I) the phase payment of RMB 164.4 million according to the cooperation and authorization agreement with Incyte, and (II) more candidate drugs entered into later clinical opening in the first half of 2019 It is caused by the increase of clinical trial expenses Sales and marketing expenses for the six months ended June 30, 2019 increased by RMB 269.5 million to RMB 279.6 million, compared with RMB 10.1 million for the six months ended June 30, 2018, which is mainly due to the successful listing of dabushu ® (cindilimab injection) in the first half of 2019 Total losses and comprehensive expenses for the six months ended June 30, 2019 increased by 656.8 million yuan to 714.4 million yuan, and for the six months ended June 30, 2018, by 57.6 million yuan The increase is mainly due to (I) a one-time non cash adjustment of HK $448.8 million to recognize the fair value gains of preferred shares in accordance with the requirements of international financial reporting standards ("international financial reporting standards"), and (II) an increase of HK $203.2 million in adjusted losses and total comprehensive expenses, mainly due to the increase in R & D expenditure Summary of business for the six months ended June 30, 2019, the group achieved a number of major milestones in terms of significant progress in drug research and business operation, including the following milestones and achievements Commercial products and related late clinical trials conducted for registration, dabushu ® (cindilimab injection) is an innovative anti-PD-1 monoclonal antibody jointly developed by Lilly and Cinda biology for the treatment of relapsed / refractory classic Hodgkin's lymphoma (R / rchl), which was approved by the National Drug Administration (nmpa) for marketing in December 2018 The product was launched on March 9, 2019 As of June 30, 2019, it has earned 331.6 million yuan Twenty clinical studies are under way to evaluate the safety and efficacy of Dabusu ® (cindilimab injection) in a variety of cancer indications, including eight registered or key clinical trials Among them, the three trials to evaluate Dabusu ® (sindilimab injection) in the second-line squamous non-small cell lung cancer (NSCLC) (orient-16), the first-line squamous NSCLC (gemcitabine and platinum, orient-32) and the first-line non squamous NSCLC (pemetrexed and platinum, orient-31) have all completed patient recruitment The first patient to complete the following trials was administered: (I) to evaluate the efficacy of Dabusu (cindilimab injection) combined with paclitaxel and cisplatin in the first-line treatment of advanced, recurrent or metastatic esophageal squamous cell carcinoma (orient-15); and (II) to evaluate the efficacy of Dabusu (cindilimab injection) combined with capecitabine and oxaliplatin in the late, recurrent or metastatic esophageal squamous cell carcinoma Stage III clinical trial (orient-16) for the first-line treatment of patients with metastatic gastric or gastroesophageal adenocarcinoma; (III) stage II / III clinical trial (orient-32) for the first-line treatment of patients with advanced liver cancer by evaluating dabushu (cindilimab injection) combined with ibi-305 (bevacizumab biological analogue); and (IV) assessment of dabushu (cindilimab injection) and ibi-305 (bevacizub injection) Combined with pemetrexed and cisplatin, mAb biosimilars were used in the phase III clinical trial (orient-31) in patients with locally advanced EGFR mutation or metastatic non squamous NSCLC Compared with the previous EGFR-TKI treatment, the patients were better We have entered into cooperation agreements with Shenzhen micro core Biotechnology Co., Ltd and shengnuoji Pharmaceutical Technology Co., Ltd to evaluate the combination therapy of Dabusu ® (sindilimab injection) and the products of these companies The clinical results (orient-1 study) of Dabusu ® (sindilimab injection) in the treatment of R / rchl patients have been published as a cover article in the lancet hematology Six key results updates on Dabusu ® (cindilimab injection) were presented at the 55th annual meeting of the American Society of Clinical Oncology (ASCO), including oral results on the treatment of recurrent / refractory extranodal NK / T-cell lymphoma (orient-4) Dabusu ® (cindilimab injection) treatment was included in the 2019 China Society of Clinical Oncology (CSCO) lymphoma diagnosis and treatment guidelines Other late clinical trials of ibi-303 (adalimumab biological analogue): NDA for rheumatoid arthritis, ankylosing spondylitis and psoriasis has been submitted to nmpa for treatment of ibi-303, which was accepted by nmpa on November 12, 2018, and obtained the priority review qualification on March 6, 2019 Ibi-305 (bevacizumab bioequivalent): NDA for the treatment of metastatic colorectal cancer and advanced, metastatic or recurrent NSCLC has been submitted to nmpa for ibi-305, which was accepted by nmpa on January 28, 2019, and obtained priority review qualification on April 29, 2019 At the 55th annual meeting of the American Society of Clinical Oncology (ASCO), the results of the first-line treatment of advanced NSCLC patients with bevacizumab were presented Ibi-301 (rituximab biological analogue): an NDA for the treatment of non Hodgkin's lymphoma (NHL) has been submitted to nmpa for the treatment of ibi-301, which was accepted by nmpa on June 28, 2019 and qualified for priority review on August 16, 2019 Ibi-306 (new anti PCSK9 monoclonal antibody): completed the phase II clinical trial of Chinese hypercholesterolemia patients, and started the phase III clinical trial for the same disease indication In the early stage, the main product development ibi-375 (pemigatinib, a new FGFR inhibitor licensed by Incyte), has submitted ind to nmpa The candidate product is currently in phase II Research in the United States for patients with advanced / metastatic or unresectable cholangiocarcinoma (including FGFR2 metastasis) who have failed treatment in the past Incyte plans to submit NDA to the U.S Food and Drug Administration (FDA) in September 2019 Ibi-376 (parsaclisib, a new PI3K δ inhibitor licensed by Incyte), has submitted ind to nmpa The candidate product is being used in a phase II study in patients with recurrent or refractory borderline lymphoma in the United States Two phase III trials are also planned in the first half of 2020 for patients with second-line follicular lymphoma, marginal zone lymphoma and first-line mantle cell lymphoma Incyte plans to submit NDA to FDA in the second quarter of 2020 Ibi-377 (itacitinib, a new Jak1 inhibitor licensed by Incyte), has submitted ind to nmpa The candidate product is undergoing phase III research in the United States for patients with first-line acute graft-versus-host disease, and Incyte plans to submit NDA to FDA in January 2020 Ibi-188 (New anti-CD47 monoclonal antibody) has been used in China and