On December 2, 2021 BeiGene (NASDAQ:BGNE; HKEX:06160), a global science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, reported that three of its medicines have been added to the most recent National Reimbursement Drug List (NRDL) in China by the National Healthcare Security Administration (NHSA) (Press release, BeiGene, DEC 2, 2021, View Source [SID1234596416]). BeiGene-discovered medicines in the updated NRDL include: anti-PD-1 antibody tislelizumab in three new indications, including in lung and liver cancers; BTK inhibitor BRUKINSA (zanubrutinib) in one new indication; and the initial listing for PARP inhibitor pamiparib. The changes to the NRDL will be effective on January 1, 2022.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The inclusion of our three internally-discovered innovative medicines in the latest NRDL will help expand access to these high-quality oncology treatments across China at affordable prices and reduce the financial burden for patients and their families"

Tweet this
"The inclusion of our three internally-discovered innovative medicines in the latest NRDL will help expand access to these high-quality oncology treatments across China at affordable prices and reduce the financial burden for patients and their families," commented Xiaobin Wu, Ph.D., President of BeiGene, Chief Operating Officer, and General Manager of China. "Since its establishment, the NHSA has accelerated the frequency of adjustment to the NRDL, forming a dynamic mechanism for annual updates. Through the establishment of a comprehensive healthcare system, life-saving innovative oncology medicines are now more quickly included in the NRDL at affordable prices, covering different types of medical care and providing benefits for people living with cancer. As an innovative company with strong R&D capabilities and global reach, BeiGene is working to change the status quo in the field of treatment and fill the gap in clinical treatment options. We look forward to working with the NHSA to fulfill the demand for these treatments across China as soon as possible."

The following indications have been included in the updated NRDL:

Tislelizumab is now included in the NRDL in all five of its approved indications – three new indications in 2021 and two indications included last year:
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 in 2021);
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 in 2021);
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 in 2021);
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 NRDL in 2020); 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 in 2020).
BRUKINSA is now included in the NRDL in all three of its approved indications – one new indication in November 2021 and two indications included last year:
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 in 2021);
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 in 2020); 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 in 2020).
Pamiparib is initially included in the NRDL in its approved indication:
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 and included in the NRDL in 2021).
About Tislelizumab

Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is the first approved medicine from BeiGene’s immuno-oncology biologics portfolio and is being further developed globally as a monotherapy and in combination with other agents for the treatment of a broad array of both solid tumor and hematologic cancers.

The China National Medical Products Administration (NMPA) has approved tislelizumab in five indications, including full approval for first-line treatment of patients with advanced squamous NSCLC in combination with chemotherapy and for first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy. NMPA also granted conditional approval for the treatment of patients with cHL who received at least two prior therapies, for the treatment of patients with locally advanced or metastatic 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, and for the treatment of patients with HCC who have received at least one systemic therapy. Full approval for these indications is contingent upon results from ongoing randomized, controlled confirmatory clinical trials.

In addition, four supplemental Biologics License Applications for tislelizumab are under review by the Center for Drug Evaluation (CDE) of the NMPA and are under review for second- or third-line treatment of patients with locally advanced or metastatic NSCLC who progressed on prior platinum-based chemotherapy, for patients with previously treated, locally advanced unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) solid tumors, for the treatment of patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have disease progression following or are intolerant to first-line standard chemotherapy, and for the first-line treatment of patients with recurrent or metastatic nasopharyngeal cancer (NPC).

In the United States, a Biologics License Application for tislelizumab as a treatment for patients with unresectable recurrent locally advanced or metastatic ESCC after prior systemic therapy is currently under review by the U.S. Food and Drug Administration with a PDUFA target action date of July 12, 2022. BeiGene has initiated or completed 17 potentially registration-enabling clinical trials in China and globally, including 13 Phase 3 trials and four pivotal Phase 2 trials. In January 2021, BeiGene and Novartis entered into a collaboration and license agreement granting Novartis rights to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan. Tislelizumab is not approved for use outside of China.

About BRUKINSA (zanubrutinib)

BRUKINSA (zanubrutinib) is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues.

BRUKINSA is approved in one or more indications in a total of 40 countries and regions, including the United States, China, the European Union, Australia and Canada. To date, more than 20 marketing authorization applications have been submitted for BRUKINSA for various indications.

About Pamiparib

Pamiparib is an inhibitor of PARP1 and PARP2 which has demonstrated pharmacological properties such as brain penetration and PARP-DNA complex trapping in preclinical models. Discovered by BeiGene scientists, pamiparib was the first PARP inhibitor approved in both platinum-sensitive and platinum-resistant relapsed ovarian cancer in China. Pamiparib is currently being evaluated globally as a monotherapy or in combination with other agents for a variety of solid tumor malignancies.

In China, pamiparib received conditional approval 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 in May 2021. Full approval for this indication is contingent upon results from ongoing corroborative trials confirming the clinical benefit of pamiparib in this population.

On December 2, 2021 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported that a poster presentation sharing new clinical data from the ongoing SRF617 Phase 1 trial will be presented at the European Society for Medical Oncology Immuno-Oncology Congress (ESMO-IO) 2021, to be held virtually from December 8 to 11, 2021 (Press release, Surface Oncology, DEC 2, 2021, View Source [SID1234596399]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The poster includes new data from the ongoing Phase 1 study of SRF617, an antibody targeting CD39, as both a monotherapy and in combination, in patients with advanced solid tumors. The full poster will be placed on Surface Oncology’s website following the presentation.

Details of Surface’s ESMO (Free ESMO Whitepaper)-IO poster presentation:

Title: First-in-human phase 1 trial of SRF617, a potent inhibitor of CD39 activity, as monotherapy or in combination, in patients with advanced solid tumors
Poster Number: 135P
Lead Author: Amita Patnaik, M.D.
Presentation Date and Time: On-demand e-Poster will be available on December 6, 2021 at 12:00 CET (6:00 a.m. ET)

On December 2, 2021 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, and Eli Lilly and Company ("Lilly") (NYSE: LLY), reported that the innovative PD-1 inhibitor sintilimab has been successfully included in the updated National Reimbursement Drug List ("NRDL") for all approved indications, according to the latest announcement from the China National Healthcare Security Administration ("NHSA") (Press release, Innovent Biologics, DEC 2, 2021, View Source [SID1234596417]). The updated NRDL will officially take effect on January 1, 2022.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A total of four approved indications for sintilimab are now included in the updated NRDL:

Three indications for sintilimab have been included in the NRDL for the first time, as follows: in combination with pemetrexed and platinum chemotherapy for the first-line treatment of advanced or recurrent nonsquamous non-small cell lung cancer (nsq NSCLC) without sensitizing EGFR mutations or ALK rearrangements; in combination with gemcitabine and platinum chemotherapy for the first-line treatment of advanced or recurrent squamous non-small cell lung cancer (sq NSCLC); and in combination with BYVASDA (bevacizumab biosimilar injection) for the first-line treatment of unresectable or advanced hepatocellular carcinoma (HCC).
An indication for relapsed or refractory classic Hodgkin’s lymphoma (cHL) after two lines or later of systemic chemotherapy, which was first included in the NRDL in 2019, has been successfully renewed this year.
Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated, "Two years ago, sintilimab was the first and only PD-1 inhibitor included in the NRDL. This year, three additional first-line indications for sintilimab have been successfully included in the NRDL, further enhancing the accessibility of this anti-cancer drug and alleviating financial burden for Chinese patients and their families. We have witnessed the profound reform and rapid development of pharmaceutical industry in China, driven by the government’s commitment to continuously support innovation and emphasize a healthier and better life for the people of China. Innovent is honored to be a part of the Chinese government’s initiative to improve health, and are devoted to the deepening of the national health care reform. With our company’s mission ‘to develop and commercialize high quality biopharmaceuticals that are affordable to ordinary people,’ we hope to continue to work together with all relevant parties to improve drug affordability and accessibility, and contribute to the ‘Healthy China 2030’ initiative."

Julio Gay-Ger, President and General Manager, Lilly China, stated, "In recent years, China has continued to intensify medical insurance reform, giving strategic priority to safeguarding people’s health. As a multinational pharmaceutical company tied with China for over 100 years, Lilly always adheres to the philosophy of ‘In China, For China’, and actively participates in China’s health reform, especially in the drug supply system. The indication expansion of sintilimab in the National Reimbursement Drugs List (NRDL) can further reduce the burden of healthcare, enabling the patients to afford innovative drugs and have a higher quality of life through persistent treatment. Lilly will continue to keep a close eye on the major healthcare challenges in China in the future, and play an important role in the country’s ‘all-round and full-cycle health’ ecosystem, to support the accelerated implementation of the ‘Healthy China 2030’ initiatives."

Mr. Min Liu, Chief Commercial Officer of Innovent, stated, "Sintilimab is the only PD-1 inhibitor in China with four major indications (1L nsq NSCLC, 1L sq NSCLC, 1L HCC and cHL) approved and included in China’s NRDL. Particularly, lung cancer and liver cancer are two of the most prevalent tumor types in China, accounting for the first and third largest numbers of new cases each year – representing a large unmet medical need. We will proactively support the work of the government departments at all levels, cooperate with the implementation of medical insurance policies in all regions, and help relieve patients’ economic burden to a further extent, to allow this high-quality immunotherapy product to benefit more lives of Chinese patients and their families."

About Sintilimab

Sintilimab, marketed as TYVYT (sintilimab injection) in China, is an innovative PD-1 inhibitor with global quality standards jointly developed by Innovent and Eli Lilly and Company. Sintilimab is an immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies of sintilimab worldwide, to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials.

In China, sintilimab has been approved and included in the National Reimbursement Drug List (NRDL) for four indications, including:

The treatment of relapsed or refractory classic Hodgkin’s lymphoma after two lines or later of systemic chemotherapy
In combination with pemetrexed and platinum chemotherapy, for the first-line treatment of nonsquamous non-small cell lung cancer
In combination with gemcitabine and platinum chemotherapy, for the first-line treatment of squamous non-small cell lung cancer
In combination with BYVASDA (bevacizumab biosimilar injection) for the first-line treatment of unresectable or advanced hepatocellular carcinoma
Additionally, Innovent currently has two regulatory submissions under review in China for sintilimab, for the first-line treatment of esophageal squamous cell carcinoma, and the first-line treatment of unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma.

Additionally, three clinical studies of sintilimab have met their primary endpoints:

Phase 2 study as second-line treatment of esophageal squamous cell carcinoma
Phase 3 study as second-line treatment for squamous NSCLC with disease progression following platinum-based chemotherapy
Phase 3 study in combination with BYVASDA (bevacizumab biosimilar injection) and chemotherapy (pemetrexed and cisplatin) for EGFR-mutated nonsquamous NSCLC following EGFR-TKI treatment
In May 2021, the U.S. FDA accepted for review the Biologics License Application (BLA) for sintilimab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of nonsquamous non-small cell lung cancer.

On December 1, 2021 Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported that the US Food and Drug Administration (FDA) is allowing the Company’s Investigational New Drug (IND) application to study WP1122 for the treatment of Glioblastoma Multiforme (GBM) to go forward (Press release, Moleculin, DEC 1, 2021, View Source [SID1234596322]). With this IND now cleared, Moleculin plans to initiate a Phase 1 open label, single arm, dose escalation study of the safety, pharmacokinetics and efficacy of oral WP1122 in adult patients with GBM.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Company believes WP1122 has significant potential as both an antiviral therapy and as a cancer therapy. Moleculin recently announced its plans to initiate a Phase 1a clinical trial of WP1122 in healthy volunteers in the United Kingdom to facilitate future testing in COVID-19 patients. This new US IND sets the stage for parallel development of WP1122 as a cancer therapy. Consistent with its strategy of leveraging external funding for many of its clinical trials, Moleculin intends to seek opportunities for an investigator-initiated clinical trial of WP1122 in cancer patients in 2022.

"This IND underscores our dual pronged approach to the development of WP1122 for the treatment of both certain types of cancers and viruses. In addition to the trial in the UK designed to position WP1122 as an antiviral therapy, we can now be advancing the cancer therapy path in parallel. Along with GBM, we believe WP1122 has the potential to be well suited as a treatment for other highly glycolytic cancers such as pancreatic cancer," commented Walter Klemp, Chairman and CEO of Moleculin.

GBM is the most aggressive malignant primary brain tumor and remains as an incurable tumor with a median survival of only 15 months1. It is the most common malignant primary brain tumor making up 54% of all gliomas and 16% of all primary brain tumors,2 and despite advancements, survival rates for patients with GBM have shown no notable improvement in population statistics in the last three decades.3 The average annual age-adjusted incidence rate of GBM is 3.19 per 100,000 persons in the United States.4

1 Koshy M, Villano JL, Dolecek TA, Howard A, Mahmood U, Chmura SJ, et al. Improved survival time trends of glioblastoma using the SEER 17 population-based registries. J Neuro Oncol. 2012;107(1):207–12

2 Ostrom QT, Gittleman H, Farah P, Ondracek A, Chen Y, Wolinsky Y, et al. CBTRUS statistical report: Primary brain and central nervous system tumors diagnosed in the United States in 2006–2010. Neuro Oncol. 2013;15 Suppl:2ii–56.

3 De Vleeschouwer S, editor. Brisbane (AU): Codon Publications; 2017 Sep 27.

4 Thakkar J, Dolecek TA, Horbinski C, Ostrom QT, Lightner DD, Barnholtz-Sloan JS, et al. Epidemiologic and molecular prognostic review of glioblastoma. Cancer Epidemiol. Biomarkers Rev. 2014;23(10):1985–96.

On December 1, 2021 Genomic Testing Cooperative, LCA (GTC) reported that it will be presenting at the annual American Society of Hematology (ASH) (Free ASH Whitepaper) meeting new data on the use of their proprietary machine learning approaches in the diagnosis of acute graft-versus-host disease (aGVHD) and for the stratifying of patients with diffuse large B-cell lymphoma (DLBCL) based on outcome after treatment with the standard R-CHOP (Press release, Genomic Testing Cooperative, DEC 1, 2021, View Source [SID1234596340]). GTC will also present studies on their liquid biopsy and its reliability in detecting cytogenetic abnormalities in myeloid neoplasms and in monitoring minimal residual disease after stem cell transplant. These studies were performed in collaboration with multiple academic institutions that contributed clinical data. GTC is the only diagnostic company that offers molecular testing based on cooperative (Co-Op) business model. By working with other members of the Co-Op, the company is able to develop and validate tests in efficient ways reducing the cost of testing and innovation. GTC shares the intellectual property rights of three of the four innovative tests with John Theurer Cancer Center and Hackensack Meridian Health, both members of the Co-Op. Dr. Andre Goy, Chairman and Chief Physician Officer at John Theurer Cancer Center, Chairman of Oncology at Hackensack Meridian School of Medicine and Professor of Medicine at Georgetown University said "being a part of the cooperative group at GTC has been extremely productive and enabled John Theurer Cancer Center to offer state-of-the-art precision medicine, not only for selecting therapy but for developing cutting edge approaches for monitoring patients".

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The presented work reflects the current GTC innovation strategy in improving cancer care. GTC uses RNA data and targeted transcriptome generated by next generation sequencing (NGS) along with new machine learning approaches to predict the presence of aGVHD and for stratifying patients with DLBCL. These are examples of how genomics can improve patient care. aGVHD remains a major cause of morbidity and mortality in patients after hematopoietic stem cell transplant. Proper and early diagnosis of this serious complication of transplant will trigger prophylaxis therapy and treatment that may improve outcome. Similarly predicting patients with DLBCL who will not respond well to the current standard R-CHOP therapy will help in selecting different therapeutic approaches and new clinical trials.

GTC is developing new indications in liquid biopsy testing and extensively exploring new technology to improve patient care. ASH (Free ASH Whitepaper) presentations show that their liquid biopsy can reliably predict cytogenetic abnormalities in patient with hematologic neoplasms and can be used for diagnosis and management of patients with myeloid neoplasm. Another presentation shows that liquid biopsy is reliable in monitoring patients after hematopoietic stem cell transplant. Dr. Maher Albitar, founder, chief medical officer, and chief executive officer of GTC stated "GTC was established as a co-op business to improve patient and democratizing genomics through efficient innovation and collaboration". He added "Advances in genomics and machine learning are opening new opportunities in medicine to improve outcome in cancer care. Our new studies that are presented at ASH (Free ASH Whitepaper) are examples of how a cooperative business model can deliver".

Following are the list and dates and times of the presentations:

1)Reliability of Liquid Biopsy and Next Generation Sequencing in Monitoring Residual Disease Post-Hematopoietic Stem Cell Transplant, Saturday, December 11, 2021: 5:30 PM-7:30 PM

2)Bone Marrow-Based Biomarkers for Predicting aGVHD Using Targeted RNA Next Generation Sequencing and Machine Learning , Sunday, December 12, 2021: 6:00 PM-8:00 PM

3)Determining Clinical Course of Diffuse Large B-Cell Lymphoma Using Targeted Transcriptome and Machine Learning Algorithms; Sunday, December 12, 2021: 6:00 PM-8:00 PM
4) Reliability of Cell-Free DNA (cfDNA) Next Generation Sequencing in Predicting Chromosomal Structural Abnormalities and Cytogenetic-Risk Stratification of Patients with Myeloid Neoplasms; Monday, December 13, 2021: 6:00 PM-8:00 PM