On January 8, 2021 HLB reported that its Chinese partner, Jiangsu Hengrui Medicine, has received marketing approval for its Rivoceranib, locally branded as Apatinib, as a second-line treatment for liver cancer from the China National Medical Products Administration (Press release, HLB, JAN 8, 2021, View Source [SID1234591437]).

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The company expects Rivoceranib to expand its market share in China with the recent authorization, following the approval as a third-line treatment for gastric cancer in 2014.

HLB’s Chinese partner, Jiangsu Hengrui Medicine, has recently received marketing approval for Rivoceranib as a second-line treatment for liver cancer from the China National Medical Products Administration. (HLB)
Liver cancer is the second most common malignancy in China following lung cancer, and more than half of all liver cancer patients in the world are Chinese.

Jiangsu Hengrui Medicine launched Rivoceranib as a third-line treatment for gastric cancer with the name Aitan in China previously, and it has been receiving health insurance benefits since.

Aitan’s sales steadily increased from about 55 billion won ($50.3 million) in 2015, the first year of launching, to 350 billion in 2019.

HLB is conducting a global phase 3 clinical trial of combination therapy of Rivoceranib and Camrelizumab, an anticancer drug developed by Jiangsu Hengrui Medicine, targeting the first-line liver cancer treatment.

The company has almost completed recruiting patients for the clinical studies, and it plans to commercialize Rivoceranib by receiving indications for gastric and liver cancer and adenocystic carcinoma.

Under the accord, HLB will receive royalties as Jiangsu Hengrui Medicine start marketing Rivoceranib. The latter performs phase 3 studies of Rivoceranib for treating breast, non-small cell lung, and ovarian cancer.

"Rivoceranib has won marketing approval in China as a treatment for liver cancer following after stomach cancer, proving its value and expandability as a new anticancer drug," an official of HLB said. "We will focus on clinical trials to expand indications and do our best to realize direct selling in addition to the royalty received."

On January 8, 2021 Neoleukin Therapeutics, Inc., "Neoleukin" (NASDAQ:NLTX), a biopharmaceutical company utilizing sophisticated computational methods to design de novo protein therapeutics, reported that on January 7, 2021, it received a clinical hold letter from the U.S. Food and Drug Administration (FDA) related to its Investigational New Drug (IND) Application to begin a Phase 1 clinical program of its immunotherapeutic candidate, NL-201 (Press release, Neoleukin Therapeutics, JAN 8, 2021, View Source [SID1234573767]).

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The FDA has informed Neoleukin that it needs to develop a new assay that more precisely measures the amount of protein being administered and demonstrate with this assay that dose and administration procedures will accurately deliver the intended dose of NL-201. The FDA also had additional requests not related to the clinical hold to be addressed by amendment of the IND.

"We will work diligently to address the FDA’s questions as quickly as possible," said Jonathan Drachman, M.D., Chief Executive Officer of Neoleukin. "We believe that we will be able to develop the requested assay and respond within the next several months. While we do not have a definitive timeline as to when we will be able to obtain clearance to proceed, we look forward to working with the FDA to satisfy their requests."

About NL-201

NL-201 is a de novo receptor agonist of the IL-2 and IL-15 receptors, designed to expand cancer-fighting CD8 T cells and natural killer (NK) cells without any bias toward cells expressing the alpha receptor subunit (CD25). Previously presented preclinical data have demonstrated the ability of NL-201 to stimulate and expand CD8+ and NK cells at low doses with minimal impact on immunosuppressive regulatory T cells.

On January 8, 2021 Abbisko Therapeutics Co., Ltd. reported the recent completion of its Series D financing of $123 million (Press release, Abbisko Therapeutics, JAN 8, 2021, View Source;article_id=157 [SID1234573766]). This investment was led by The Carlyle Group, with Warburg Pincus, OrbiMed, Lake Bleu Capital, and a Boston-based investor as the joint leading investors. Janchor Partners, Sage Partners, SHC, Greater Bay Area Homeland Development Fund and another strategic investor, as well as existing investors including Lilly Asia Ventures, Temasek Holdings, Qiming Venture Partners, Hankang Capital and CICC Capital also joined. This round of financing brought the total capital that Abbisko has raised to $263 million. The proceeds from this round will be used to accelerate the progress of the Company’s clinical programs and further expand its preclinical pipeline consisting of multiple programs in discovery to IND-enabling stages.

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Since the establishment in 2016, Abbisko has built up an extensive small molecule pipeline in oncology targeted therapy and immune-oncology areas. Among them, four programs have advanced into clinical stage with seven IND approvals already obtained in different regions of the world. Abbisko has also established a number of collaborations with other pharmaceutical companies such as AstraZeneca and X4 Pharmaceuticals to strengthen its portfolio and research and development globally.

Dr. Yao-Chang Xu, the founder and CEO of Abbisko Therapeutics said, "We are grateful and honored to have Carlyle, Warburg Pincus and other prestigious international healthcare investors to join this round of financing, as well as the continued support from our existing investors. This investment not only demonstrated the recognition of our achievements and progresses by the top healthcare investors, but also shows our strategic investors’ confidence in the future success of our company. The fund and resources obtained in this round will allow us to rapidly advance our clinical programs and also continue to accelerate and expand our portfolio programs in the discovery and preclinical development stages."

Ling Yang, a Managing Director of the Carlyle Asia advisory team, commented: "Abbisko has achieved significant research and clinical progress since its establishment in 2016, showcasing its strong R&D capabilities led by one of China’s most seasoned management teams. The Company’s strong pipeline, in-house discovery engine, and experienced team make this a rare and exciting partnership and investment opportunity for Carlyle. We look forward to working with the Company to capture the growing opportunity in both the domestic and global biotech market."

Fred Hassan, an iconic industry leader who is a current board member of Amgen and former Chairman and CEO of Schering Plough, commented on behalf of Warburg Pincus， "We are deeply impressed by Abbisko’s deep bench of talent in the small molecule oncology field and believe it is well positioned to develop world-class innovative medicine for global markets. Warburg Pincus, with a long history of investing in life sciences globally, will leverage its network to help the Company to accelerate global partnership and global clinical development".

On January 8, 2021, Shenzhen Chipscreen Biosciences Co., Ltd. (Chipscreen Biosciences, Stock Symbol: 688321.SH) reported that it submitted its pivotal phase III clinical trial application (IND) of national class I innovative drug Chiauranib to NMPA, for the treatment of Small Cell Lung Cancer (SCLC) as a single agent for the patients after 2nd-line systemic chemotherapy and recurrence afterwards (Press release, Shenzhen Chipscreen Biosciences, JAN 8, 2021, View Source [SID1234573762]). The submission has been accepted by the Center of Drug Evaluation of the NMPA. (Acceptance number: CXHL2100009).

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The population of SCLC patients account for about 15-20% of all lung cancer patients. Comparing to Non-Small Cell Lung Cancer(NSCLC), it is still not clear about tumor driving gene in the development of SCLC, and thus it is lacking of targeted therapeutic treatment for this life threaten disease. For the moment, the main clinical treatment methods of SCLC are radiotherapy and chemotherapy, which may only have short-term effect, and the disease is easy to relapse. The current efficacy of treatments to SCLC is far behind that of NSCLC. There is an urgent need for innovative drugs to treat SCLC.

Chiauranib has a new chemical structure which is under global patent protection. The compound is independently designed and developed by Chipscreen Biosciences. It is a highly-selective Aurora B, CSF1R, VEGFR/PDGFR/c-Kit inhibitor, which exerts a comprehensive anti-tumor effect by simultaneously inhibiting tumor angiogenesis, inhibiting tumor cell mitosis and regulating tumor microenvironment. Chiauranib has shown pharmacological activity superior to that of other similar drugs in animal studies. In the meantime, it has an excellent safety profile despites being a multi-target kinase inhibitor. Chiauranib as a single agent therapy inhibits the overactive Aurora B pathway existed in and related to molecular mechanism of SCLC, which is an important feature of Chiauranib distinct to other antiangiogenic drugs. In the previous clinical trials, compared with the historical control data, the monotherapy of Chiauranib has achieved promising results in the treatment of SCLC patients who have failed other multi-line therapies. As an innovative drug with obvious clinical advantages among the treatments of SCLC, on December 25 2020, Chiauranib has been designated as a "Breakthrough Treatment" by CDE for the indications of SCLC.

The accepted IND submission is a pivotal phase III, randomized controlled, double-blind, multicenter study, which aims to confirm the efficacy and safety of Chiauranib monotherapy to treat SCLC after 2nd-line systemic chemotherapy and recurrence afterwards. Professor Shi Yuankai from the Cancer Hospital of Chinese Academy of Medical Sciences is the leading principle investigator of the trial.

Dr. Lu Xianping, Founder, Chairman and General Manager of Chipscreen Biosciences, says:

"The designation of Chiauranib as a "Breakthrough Treatment" and acceptance of its pivotal phase III clinical trial design by NMPA, have fully reflected Chinese drug regulatory authorities’ attention and efficient execution to facilitate the development of innovative drugs in China. This also lays a good start for the further development of Chiauranib, which is the third original innovative drug discovered and developed by Chipscreen. Chipscreen will start the phase III clinical trial of Chiauranib in the treatment of SCLC as soon as possible while its submission to start clinic trial in US is underway. We believe Chiauranib will eventually provide innovative treatments to the needed cancer patients in the future because of its unique mechanism of action ."

At the same time, Chipscreen Biosciences is completing a number of phase II clinical trials of Chiauranib in China for the treatments of some other indications, including ovarian cancer, non Hodgkin’s lymphoma, and liver cancer, which the trials have showing positive clinical efficacy and excellent safety.

At present, Chiauranib has globally applied for more than 40 patents of invention.

On January 8, 2021 Nuvation Bio Inc., a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, reported that David Hung, M.D., founder, president and chief executive officer, will present virtually at the 39th Annual J.P. Morgan Healthcare Conference on January 11, 2021 at 2:35 p.m. Eastern Time (Press release, Nuvation Bio, JAN 8, 2021, View Source [SID1234573728]).

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