On December 2, 2021 Tavros Therapeutics, a privately held biotechnology company discovering first-in-class cancer therapies, and OpenBench, an emerging leader in AI-enabled small molecule discovery, reported a collaboration in which OpenBench will identify novel, potent antagonists against an undisclosed cancer target that was identified by Tavros’s proprietary functional genomics platform (Press release, Tavros Therapeutics, DEC 2, 2021, View Source [SID1234596421]).

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Under the terms of the agreement, OpenBench will receive payment for the identification and experimental confirmation of novel chemotypes that meet Tavros’s potency and developability criteria. In exchange, Tavros gains exclusive access to OpenBench’s proprietary screening technology with respect to the promising cancer target. Financial terms were not disclosed.

"Tavros is eager to identify quality hit molecules against this high-impact, first-in-class target, and we think OpenBench’s virtual screening platform is perfectly suited to accelerate our drug development timelines. We hope to continue this partnership and take on other promising drug targets identified by Tavros’s proprietary functional genomics discovery platform," said Tavros CEO Eoin McDonnell.

"We are excited to enrich Tavros’s efforts to make a breakthrough therapeutic discovery addressing a serious clinical need," said OpenBench CTO James Yoder. "We feel confident that the partnership will bear fruit and the OpenBench virtual screening platform will identify promising novel chemical material that maximizes the likelihood of Tavros’s success in lead optimization, translation, and clinical development campaigns."

OpenBench adds Tavros to a growing list of partners that includes HemoShear Therapeutics and two other undisclosed U.S.-based biotechnology companies.

On December 2, 2021 IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) ("IceCure" or the "Company"), developer of minimally-invasive cryoablation technology, the ProSense System, that destroys tumors by freezing as an alternative to surgical tumor removal, reported that interim data from the ICE3 Clinical Trial on cryoablation of small, low-risk breast cancer was featured by Co-Primary Investigator, Dr. Kenneth Tomkovich at the Radiologists Society of North America (RSNA), which was held from November 29th through December 2nd (Press release, IceCure Medical, DEC 2, 2021, View Source [SID1234596420]). Dr. Tomkovich’s presentation, "Primary Treatment of Low Risk Breast Cancers Using Image-Guided Cryoablation: A 6 Year Update of the ICE3 Trial" was selected to be featured in a daily bulletin by RSNA, the largest radiology society in the world with over 48,000 members in the United States, representing 31 radiologic sub-specialties sharing state-of-the-art radiological innovations.

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Dr. Tomkovich featured the ICE3 interim results on Tuesday, November 30th as part of the larger "Breast Imaging (Breast Intervention and PET/Breast Imaging in Neoadjuvant Chemotherapy" session.

Eyal Shamir, Chief Executive Officer of IceCure, noted, "We are proud that our data was recognized by the Radiology Society of North America,(RSNA), the largest radiology society in the world and a highly regarded medical association. We believe this recognition by this prestigious society is further supportive of the ICE3 data."

Dr. Tomkovich commented, "The acceptance of cryoablation as a treatment for breast cancer is becoming more wide-spread in the radiological medical community and the interim ICE3 trial results continue to validate this approach. It is an option that could be much more convenient than a mastectomy or lumpectomy surgery, in terms of requiring less office time, as well as less stress and a quick recovery for the patient."

On December 2, 2021 InnoCare Pharma (HKEX: 09969), a commercial-stage biotech company, reported that its BTK inhibitor orelabrutinib has been included in the updated National Reimbursement Drug List (NRDL) by the China National Healthcare Security Administration (NHSA) (Press release, InnoCare Pharma, DEC 2, 2021, View Source [SID1234596419]). Orelabrutinib is an oral, once-daily BTK inhibitor with national Category 1 designation. It is included in the NDRL as the treatment of patients with r/r Chronic Lymphocytic Leukemia (CLL) /Small Lymphocytic Lymphoma (SLL), and the treatment of patients with r/r Mantle Cell Lymphoma (MCL).

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"Lymphoma is one of the malignant tumors with the fastest growth of incidence rate and one of the top ten malignant tumors with the highest mortality rate in China. The inclusion of orelabrutinib in the NRDL could significantly improve access of this innovative drug in China, which can benefit more patients," said Dr. Jasmine Cui, the co-founder, chairwoman and CEO of InnoCare.

"We are grateful that orelabrutinib has been included in the NRDL. We will continue to fulfil our mission — ‘Science drives innovation for the benefit of patients’, and accelerate exploring more indications for orelabrutinib," said Dr. Cui.

Orelabrutinib has excellent target selectivity with near 100% BTK occupancy. Orelabrutinib’s once-daily oral administration is convenient for continued treatment.

About Orelabrutinib
Orelabrutinib is a small molecule Bruton’s tyrosine kinase inhibitor (BTKi) developed for the treatment of cancer and autoimmune diseases.

Orelabrutinib had received approval on Dec. 25, 2020 from the China National Medical Products Administration (NMPA) in two indications: the treatment of patients with r/r Chronic Lymphocytic Leukemia (CLL) /Small Lymphocytic Lymphoma (SLL), and the treatment of patients with r/r Mantle Cell Lymphoma (MCL). In addition, multi-center, multi-indication clinical trials are underway in the US and China for orelabrutinib as monotherapy or in combination therapies for the treatment of Marginal Zone Lymphoma (MZL), Central Nervous System Lymphoma (CNSL), Waldenstrom’s Macroglobulinemia (WM), Diffuse large B-cell lymphoma (DLBCL), etc.

Orelabrutinib was granted as Breakthrough Therapy Designation for the treatment of r/r MCL by U.S. Food and Drug Administration (FDA).

Attributed to its excellent selectivity and clinical safety profiles, orelabrutinib is also evaluated in the global phase II studies for the treatment of Multiple Sclerosis (MS), phase II clinical trials for the treatment of Systemic Lupus Erythematosus (SLE) and Primary Immune Thrombocytopenia (ITP) in China.

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.

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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 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.

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"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"

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"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.