On October 29, 2021 Novo Nordisk reported that the full-year sales and operating profit outlook at constant exchange rates (CER) has been raised (Press release, Novo Nordisk, OCT 29, 2021, View Source [SID1234592189]).

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In the third quarter of 2021, Novo Nordisk’s sales increased by 15% and operating profit increased by 19%, both at CER. The operating profit increase was positively impacted by the amortisation of the priority review voucher for Wegovy in the third quarter of 2020.

Following the financial results for the first nine months of 2021, the outlook for 2021 is updated. The updated outlook is reflecting higher than expected Ozempic market share gains, GLP-1 market growth and obesity care sales, mainly in the US.

Novo Nordisk’s full disclosure of the financial results for the first nine months of 2021 will be published on 3 November 2021.

The above expectations are based on assumptions including those described on pages 16 and 17 of the Financial report for the period 1 January 2021 to 30 June 2021 (Company Announcement No 48 / 2021).

On October 29, 2021 Yiling Pharmaceutical reported the three-quarter report on the evening of October 28 (Press release, Yiling Pharmaceutical, OCT 29, 2021, View Source [SID1234592205]). In the first three quarters, the operating income of the company reached CNY 8.112 billion, up 25.81% year on year; the net profit attributable to shareholders of the listed company hit CNY 1.224 billion, up 20.43% from the previous year, surpassing that of last year as a whole; the weighted average return on equity was 13.40%, up 1.22 percentage points over the same period last year.

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In terms of marketing, the company has always adhered to academic promotion, relied on existing product lines, continuously integrated internal and external resources, optimized the sales management model, strengthened the professional construction of the sales team, and continuously advanced the optimization and upgrading of the marketing system. Benefiting from the "Construction of TCM Collateral Theory and Its Guidance for Prevention and Treatment of Microangiopathy" which won the First Prize of the National Science and Technology Progress Award in 2019, the company’s cardiovascular and cerebrovascular products achieved accelerated growth and its market share continued to rise. In addition, the company’s second-tier products were continuously promoted by the company’s academic and social brands, and the marketing system was optimized and upgraded, realizing rapid growth.

In terms of R&D, in the first three quarters of this year, the R&D expenditure amounted to CNY 538 million, with a year-on-year increase of 37.86%, which was higher than the growth rate of the operating income, showing that the company continued to increase R&D investment and the efficiency of R&D output also continued to improve. In terms of TCM, the company strengthened the establishment of the evidence system for registration and evaluation of TCM, which integrates TCM theory, human experience and clinical trials, continued the core theoretical advantages and systematic R&D advantages of TCM, and continuously enriched the R&D array of TCM varieties. The company’s patented new drug Tablet for Tonifying Kidney, Nourishing Heart and Tranquilizing Mind used for the treatment of insomnia was approved for marketing in September. Besides, Suxia Capsule for Dispel Melancholy and Relieving Restlessness used for the treatment of mild and moderate depression was filed for production in March. The company is expected to achieve a breakthrough in the nervous system field. Moreover, Lianhua Qinggan Granule for Children was approved to enter the clinical study stage. The company also introduced Rujietai products, enriching the product lines and filling in a gap in the field of gynecological products. In terms of chemical drugs, Felbinac Trometamol, a new drug in Category I, passed the CDE publicity and entered the third clinical stage. It is expected to become the company’s first approved new drug in Category I of chemical drugs.

According to the latest research report released by Ping An Securities, Yiling Pharmaceutical’s Lianhua Qingwen boasts a solid customer base in the antivirus field, and its market share continues to increase; its second-tier products are at the market expansion stage, with steady sales growth. Dongxing Securities believes that, based on the exclusive theory of collateral disease, the company has built core product lines of major varieties of Chinese patent medicines such as cardio-cerebrovascular series of products and Lianhua Qingwen series of products; the second- and third-tier products are also rich in varieties; the channel sales and promotion capabilities in the end-use market are also the company’s unique advantages; at present, the structural adjustment of the company’s sales staff have been completed in line with the product lines, and the number of sales staff has greatly increased; the refined coverage in the end-use market and the expansion of the grass-roots market are expected to enhance the continuous improvement of the market penetration rate of all products.

On October 29, 2021 BridgeBio Pharma, Inc. (Nasdaq: BBIO), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, reported two new academic collaborations with Columbia University and Mount Sinai (Icahn Mount Sinai) to translate cutting-edge research discoveries into potential therapies for patients with genetic diseases and genetically driven cancers (Press release, BridgeBio, OCT 29, 2021, View Source [SID1234592174]).

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"Columbia University and Mount Sinai are known for bringing together some of the most talented scientists to develop breakthroughs for patients. By partnering with these world-class research institutions, we are hopeful that together we will be able to help patients in need," said BridgeBio founder and CEO Neil Kumar, Ph.D.

BridgeBio has initiated 25 collaborations with leading institutions around the world that are focused on providing therapeutic options to patients with unmet need as quickly and safely as possible. To learn more about some of the institutions BridgeBio is proud to partner with, please visit Our Partners page.

Collaborating with academic institutions to identify early discoveries is a core pillar of BridgeBio’s efforts to reach patients more quickly. The goal of these collaborations is to revolutionize the relationships between drug development companies and biomedical research institutions by moving away from one-off interactions in favor of engaging and creative partnerships.

More than two-thirds of BridgeBio’s 30+ pipeline programs have come from partnerships with academic institutions and research centers. For example, BridgeBio’s clinical trial of encaleret, which is being investigated for the treatment of autosomal dominant hypocalcemia type 1 (ADH1), has been enabled by a Cooperative Research and Development Agreement with the National Institute for Dental and Craniofacial Research at the National Institutes of Health. BridgeBio’s investigational medicine acoramidis, which is being developed for the treatment of transthyretin (TTR) amyloidosis (ATTR), originated in a lab at Stanford University. BridgeBio partnered with the Stanford researchers and advanced acoramidis from the lab to Phase 3 clinical development in less than three years.

With a diverse pipeline encompassing investigational therapies in Mendelian diseases, precision cardiorenal, precision oncology and gene therapy, BridgeBio provides the insights and support needed to rapidly progress therapeutic research from labs to clinical development. BridgeBio intends to develop similar long-term partnerships based on trust, engagement, science and respect to support its mission of developing potentially life-changing medicines for patients with genetic diseases and cancers as quickly and safely as possible.

On October 29, 2021 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported that it will report third quarter 2021 financial results after the U.S. financial markets close on Thursday, November 4, 2021 (Press release, Oncternal Therapeutics, OCT 29, 2021, View Source [SID1234592190]). Oncternal’s management will host a webcast at 2:00 p.m. PT (5:00 p.m. ET) to provide a comprehensive business update and discuss the Company’s financial results.

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The live webcast of the call will be available online at investor.oncternal.com and the call will be archived there for at least 30 days.

On October 29, 2021 IMPACT Therapeutics reported that its ATR inhibitor IMP9064 has received the IND clearance from the U.S. Food and Drug Administration (FDA) for the Phase I/II clinical study, which will begin soon in the U.S (Press release, Impact Therapeutics, OCT 29, 2021, View Source [SID1234592206]). This will be the first in human study for the ATR inhibitor of IMPACT Therapeutics, representing a major leap of the company’s global development strategy for its synthetic lethality pipelines.

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This study is designed as a Phase I/II, dose escalation and expansion study, including individual arms to evaluate the safety, pharmacokinetics, and anti-tumor activities of IMP9064 as monotherapy and in combination with PARP inhibitor Senaparib in patients with advanced solid tumors.

IMP9064 is an ATR inhibitor discovered and developed by IMPACT Therapeutics, with worldwide intellectual property rights. In preclinical studies, IMP9064 was found to be a highly potent ATR inhibitor and is selective against other kinases. Additionally, IMP9064 has demonstrated high activities in several ATM-deficient cell lines and more active than reference compound in xenograft in vivo models, which could potentially lead to a wider therapeutic window, better tolerability in long-term administration as a single agent, and providing more flexibility in combination therapy. Senaparib, a PARP inhibitor developed by IMPACT Therapeutics, has been explored in several clinical studies worldwide. IMP9064 in combination with Senaparib will be evaluated in this clinical study to explore the combination therapy of an ATR inhibitor and a PARP inhibitor, which is highly anticipated in the DNA Damage Response (DDR) research field.

ATR is a synthetic lethality target of ATM mutations, which are commonly found in hematologic malignancies as well as a variety of solid tumors. ATR inhibitors have demonstrated proof-of-concept (POC) efficacy data in tumors harbored ATM mutations in previous clinical studies, and ATR is considered as one of the most promising synthetic lethality targets after PARP. Data from an ongoing ATR inhibitor clinical study presented at TRIPLE Conference 2021 showed that ATR inhibitor exhibits good efficacy as a monotherapy, but there is still significant room for improvement. This raised stronger interest to investigate combination of ATR inhibitor with other drugs. Among them, the combination of ATR inhibitor with PARP inhibitor is especially promising. In addition, the combination of ATR inhibitor with PARP inhibitor might overcome PARP inhibitor monotherapy resistance. As a company with both ATR inhibitor and PARP inhibitor in development, IMPACT Therapeutics is better positioned to study the combination therapy of ATR inhibitor with PARP inhibitor.

Combination therapy approach has been widely recognized as a major trend in the development of synthetic lethality-based therapeutics and targeted anticancer therapeutics to expand indications as well as to enhance anti-tumor activity. As a biopharmaceutical company dedicated to the discovery and development of novel therapeutics based on synthetic lethality, IMPACT Therapeutics has built extensive DNA Damage Response (DDR) pipelines including PARP, Wee1, ATR, and ATM inhibitors. IMPACT’s compounds were uniquely designed to have high activity and selectivity, which enables the company to target broader cancer indications and provide more opportunities for its in-house combination therapies.

Dr. Chih-Yi Hsieh, Senior Vice President and Chief Medical Officer said, "The pre-clinical data of IMP9064 has demonstrated its superiority among the same-class compounds. The clearance of this clinical program in the U.S. will enable us to validate the high potency, high selectivity, and robust anti-tumor activity of IMP9064 in the clinical study. IMPACT has formulated a differentiated clinical strategy for our ATR inhibitor which could advance the clinical development as efficient as possible, expand our synthetic lethality pipelines, and benefit more patients worldwide."