On January 6, 2021 Genetron Holdings Limited ("Genetron Health" or the "Company") (Nasdaq: GTH), a leading precision oncology company in China that specializes in offering molecular profiling tests, early cancer screening products and companion diagnostics development, and Chia Tai Tianqing Pharmaceutical Group Co., Ltd. ("CTTQ"), a subsidiary of Sino Biopharmaceutical Limited ("Sino Biopharm") (HKEX: 1177), reported an exclusive strategic partnership agreement for HCCscreen, Genetron Health’s blood-based early screening test for hepatocellular carcinoma ("HCC") in China (Press release, Genetron Health Technologies, JAN 6, 2021, View Source [SID1234573573]). This partnership targets the hospital market in China, with a focus on combatting liver disease, and marks Genetron Health’s third key commercialization initiative of HCCscreen in the country, complementing its existing sales and marketing strategies through public health programs and medical examination centers.

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!

Under the agreement, the companies will work together exclusively to co-market and co-promote HCCscreen in the hospital market, covering designated territories in China. The parties intend to target high-risk individuals for HCC, which include HBV-positive carriers, as well as other liver disease patients. CTTQ brings an experienced sales force and valuable hospital relationships to the partnership, while Genetron Health provides manufacturing and laboratory operations for its innovative product, HCCscreen, along with its direct-to-consumer marketing expertise. Genetron Health will pay CTTQ a promotional fee based on a percentage of revenues generated from the collaboration. Contingent on certain sales and other requirements, the exclusivity period is expected to last three years. As a result of the agreement, Genetron Health expects HCCscreen revenues to further accelerate in China.

Sino Biopharm is one of the leading biopharmaceutical companies in China, with therapeutic areas spanning liver disease, oncology, orthopedics, infectious, respiratory, and cardiovascular and cerebrovascular diseases. Sino Biopharm recorded sales exceeding RMB 24 billion in 2019, of which liver drugs accounted for almost a quarter. CTTQ is Sino Biopharm’s largest subsidiary, which focuses primarily on liver disease and oncology drugs R&D and manufacturing. In China, CTTQ had over 35% market share based on total hepatitis antiviral drug sales in 2018, according to IMS. In addition, CTTQ has a sales team of over 7,000 representatives and a network of over 2,000 general and liver disease-focused hospitals. Designated as a national key high-tech enterprise, CTTQ spends around 10-12% of revenues annually on research and development.

"We are excited to partner with Genetron Health as both companies are committed to developing innovative products for liver disease and oncology. HCCscreen presents an attractive opportunity to us because of its target uses in high-risk individuals for the early detection of HCC," said Eric Tse, Chairman of CTTQ. "We believe that our specialty, capabilities and network in the liver disease market represent a major sweet spot for this product. And more importantly, we are excited to introduce an innovative product that can potentially alleviate the heavy burden on liver cancer patients in China."

"Genetron Health strives to innovate while continuing to explore the commercialization roadmap for our products. For HCCscreen, we have achieved success in expanding sales channels through medical examination centers and government procurement projects. Today’s announcement marks a new channel focusing on the hospital market, and represents the third key commercialization initiative we have embarked on. CTTQ is an ideal partner for HCCscreen because of its liver drug franchise and significant sales and marketing strengths. We expect this strategic partnership to bring us closer to our goal of lowering liver cancer-related death rates in China," said Sizhen Wang, co-founder and CEO of Genetron Health.

About HCCscreen and Liver Cancer

In September 2020, Genetron Health received the U.S. Food and Drug Administration ("FDA")’s Breakthrough Device designation for HCCscreen, and the product has been commercialized recently as a lab developed test ("LDT") in China.

Globally, liver cancer is the fourth most common cause of cancer-related death and the sixth in terms of incidence1. China represents the largest market, accounting for almost half of the global incidences. New incidence in China was estimated to be around 393,000 per year, with 369,000 deaths2. Market data by Frost and Sullivan estimated that as of 2019, among the 120 million high risk liver cancer population in China, around 74 million were HBV carriers.

Powered by Genetron Health’s innovative and proprietary Mutation Capsule technology, which enables detection of multiple methylation alterations in parallel with mutations in cell-free DNA from peripheral blood specimens, HCCscreen is currently being tested in its ongoing prospective study with 4,500 HBsAg+ individuals in HCC. As of the date of this announcement, 2,000 patients have already completed the study, and preliminary data from 297 patients at one center has demonstrated over 92% sensitivity, 93% specificity, compared to 67% and 99%, respectively in the ultrasound plus alpha-fetoprotein (AFP) arm. HCCscreen also achieved a 35% positive predictive value and 99.6% negative predictive value. Furthermore, stratifying by tumor sizes, of the 12 patients identified with HCC in the preliminary dataset, seven patients had tumor sizes of less than 3 centimeters, and HCCscreen successfully detected them all, indicating its ability in detecting early-stage HCC.

In November 2020, Genetron Health announced that HCCscreen was selected by the National Cancer Center and Wuxi municipal government in China for use in the "Liver Cancer Early Screening Comprehensive Prevention and Control Project", a public health initiative (the "Project"). The goal of the Project is to increase the awareness of liver cancer early screening, and to become a pilot city model in China. For the Project, Wuxi is committed to administering 150,000 tests over a period of three years.

On January 6, 2021 Everest Medicines (HKEX 1952.HK), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other parts of Asia, reported that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of the People’s Republic of China has approved a Clinical Trial Application (CTA) for sacituzumab govitecan-hziy for the treatment of patients with metastatic urothelial cancer (mUC) (Press release, Everest Medicines, JAN 6, 2021, View Source [SID1234573590]).

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!

With this CTA, Everest Medicines plans to enroll patients in China as part of the Phase 3, global, multicenter, open-label randomized controlled TROPiCS-04 trial. The trial will evaluate sacituzumab govitecan-hziy compared with standard of care chemotherapeutic options in subjects with metastatic or locally advanced unresectable urothelial cancer who have progressed after prior therapy with a platinum-based regimen and anti-programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) therapy. Subjects will be randomized to receive either sacituzumab govitecan-hziy or Treatment of Physician’s Choice (TPC), including paclitaxel, docetaxel, and vinflunine.

Positive results from the pivotal Phase 2 TROPHY U-01 study of sacituzumab govitecan-hziy in 113 mUC patients, presented at the ESMO (Free ESMO Whitepaper) 2020 annual conference, confirmed earlier study results showing sacituzumab govitecan-hziy has significant activity and is safe in patients with heavily pretreated mUC who progressed on both platinum-based chemotherapy and checkpoint inhibitors (CPI). Results from the study showed that sacituzumab govitecan-hziy achieved a 27% overall response rate (ORR) and a median duration of response (DOR) of 5.9 months in heavily pre-treated patients with mUC. Sacituzumab govitecan-hziy has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) in this indication.

"Based on the compelling results generated to date, we believe that sacituzumab govitecan-hziy has the potential to offer patients with mUC a new treatment option, which may advance current standards of care and treatment," said Yang Shi, Chief Medical Officer for Oncology at Everest Medicines. "Urothelial cancer is one of the most common urologic malignancies in China, with both incidence and mortality rates gradually increasing in recent years. We look forward to working with investigators and patients to initiate this study in China."

About Urothelial Cancer

Urothelial cancer is a type of cancer that begins in urothelial cells that line the urethra, bladder, ureters, renal pelvis, and some other organs that make up the urinary system. According to Frost & Sullivan, in 2019, the incidence of urothelial cancer reached 76.4 thousand in China.

About Sacituzumab Govitecan-Hziy

Sacituzumab govitecan-hziy is a first-in-class, antibody-drug conjugate (ADC) directed at TROP-2, a membrane antigen that is over-expressed in many common epithelial cancers. Under a licensing agreement with Gilead Sciences, Inc., Everest Medicines has exclusive rights to develop, register, and commercialize sacituzumab govitecan-hziy for all cancer indications in Greater China, South Korea, and certain Southeast Asian countries.

On January 6, 2021 TRACON Pharmaceuticals (NASDAQ: TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., reported that Charles Theuer, M.D., Ph.D., President and Chief Executive Officer, will present a corporate overview at the H.C. Wainwright Virtual BioConnect 2021 Conference, being held January 11-14, 2021 (Press release, Tracon Pharmaceuticals, JAN 6, 2021, View Source [SID1234573539]).

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 presentation will be available on-demand beginning on Monday, January 11, 2021, in the Investors section on the Company’s website at www.traconpharma.com.

On January 6, 2021 Erasca, a company whose mission is to erase cancer, announced the expansion of its pipeline of precision oncology therapies via two exclusive, worldwide agreements directed at targeting critical upstream and downstream nodes in the RAS/MAPK signaling cascade, one of the most frequently mutated oncogenic pathways in cancer (Press release, Erasca, JAN 6, 2021, View Source [SID1234573557]). ERAS-601, a potential best-in-class inhibitor of the Src homology region 2 domain-containing phosphatase-2 (SHP2), was licensed from NiKang Therapeutics, Inc. ERAS-007, a potential best-in-class inhibitor of the extracellular signal-regulated kinase (ERK), the most distal node of the RAS/MAPK pathway, was acquired from ASN Product Development, Inc., a wholly-owned subsidiary of Asana BioSciences, LLC.

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!

"Our first of multiple strategies to erase cancer is a powerful MAPK Clamp that targets upstream and downstream nodes in the RAS/MAPK pathway with combination therapies to shut down, or clamp, the signaling of various oncogenic drivers trapped in between," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO and co-founder. "With this approach, we hope to induce tumor regression in RAS/MAPK-driven cancers, while also blocking their main escape routes. We believe we are the only company in the world combining clinical stage SHP2 and ERK inhibitors with potential best-in-class profiles into a MAPK Clamp to address areas of significant unmet medical need in cancer treatment. We are grateful to the NiKang and Asana teams for developing these outstanding programs, and Erasca is excited to advance them for the benefit of patients with cancer. With both ERAS-601 and ERAS-007, we look forward to exploring multiple therapeutic combinations with Erasca’s other pipeline programs and with external partners’ agents."

Under the terms of the NiKang agreement, Erasca licensed exclusive, worldwide rights to ERAS-601 and all other SHP2 inhibitors developed by NiKang. Under the terms of the Asana agreement, Erasca acquired exclusive, worldwide rights to ERAS-007 and all other ERK inhibitors developed by Asana. Financial terms of both agreements were not disclosed.

"We are proud for Erasca to continue the development of ERAS-007 after Asana achieved a critical inflection point, demonstrating safety and durable efficacy, including multiple objective responses with complete and partial regression of target lesions, in a Phase 1 clinical study," said Sandeep Gupta, Ph.D., Asana’s founder, president and CEO. "Erasca’s bold mission to erase cancer, its team’s prior experience in leading multiple global regulatory approvals, and their robust portfolio make Erasca the ideal partner to advance this program into later-stage development and commercialization."

Zhenhai Gao, Ph.D., NiKang’s co-founder and president, added, "SHP2 inhibition has emerged as the backbone of combination therapy for RAS/MAPK-driven tumors. We are thrilled to partner with Erasca on this potential best-in-class SHP2 inhibitor. By demonstrating preclinically superior activity to other compounds in development and desirable physicochemical and pharmacokinetic properties, ERAS-601 is well-positioned to be the preferred targeted therapy combination partner of choice."

Erasca also announced the dosing of a first patient in December 2020 in Erasca’s FLAGSHP-1 study, a Phase 1/1b clinical trial to evaluate ERAS-601 in patients with advanced solid tumors.

Dr. Lim further commented, "Millions of people are battling cancer daily. Since commencing operations in Q4 2018, Erasca has been deeply committed to our mission of erasing cancer by advancing innovative therapies to the clinic. We are delighted to achieve this meaningful milestone of dosing the first patient in FLAGSHP-1 and transitioning into a clinical development stage company in roughly two years from our founding. If ERAS-601 successfully blocks SHP2 activity in patients, it has the potential to become a flagship therapy for many patients with various solid tumors."

The FLAGSHP-1 trial is a global, open-label, multi-center, dose escalation and expansion study designed to evaluate the safety, pharmacokinetics, pharmacodynamics and preliminary antitumor activity of ERAS-601. Renowned cancer research institutes participating in the clinical trial include Memorial Sloan Kettering Cancer Center, MD Anderson Cancer Center and Sarah Cannon Research Institute in the US, and Linear Clinical Research and Peter MacCallum Cancer Centre in Australia. Additional information about the clinical study is available at ClinicalTrials.gov (NCT04670679).

On January 6, 2021 Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT) ("Rocket"), a clinical-stage company advancing an integrated and sustainable pipeline of genetic therapies for rare childhood disorders, reported that Gaurav Shah, M.D., Chief Executive Officer and President of Rocket is scheduled to present on Monday, January 11, 2021, at 2:50 p.m. Eastern Time at the 39th Annual J.P. Morgan Healthcare Conference (Press release, Rocket Pharmaceuticals, JAN 6, 2021, View Source [SID1234573574]).

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 live audio webcast of the presentation will be available on the Investors section of the company’s website, www.rocketpharma.com. A replay of the presentation will be archived on the Rocket website following the conference.