Hello! Welcome to PharmCube’s channel. This is Shero reporting. PharmCube is a China-based data & media company focusing on unearthing the trends in the Chinese pharmaceutical industry. In this video, I’ll be covering major progress in drug R&D, approvals and pharma deals taking place in the previous month in China. Before we start, don’t forget to hit the subscribe button so that you won’t miss our monthly update.

I’ll start from drug approvals in July. Last month, 4 products received green light in China, such as Cosela by Simcere, azvudine by Genuine Biotech, etc.

Let’s have a look at some products.

Cosela (trilaciclib for injection) is a CDK4/6 inhibitor in-licensed by Simcere from G1 Therapeutics in August 2020 for $170 million, and was approved in China on July 13 to reduce the incidence of chemotherapy-induced bone marrow suppression in adults being treated for extensive-stage small cell lung cancer. In the US, G1 Therapeutics announced FDA approval for the drug in February 2021. Currently, Simcere is also investigating trilaciclib in Phase III trials in Chinese patients with triple-negative breast cancer and colorectal cancer.

On July 25, China approved azvudine for COVID19 treatment. Azvudine is a nucleoside reverse transcriptase inhibitor that acts against HIV, HBV, and HCV, jointly developed by Genuine Biotech, Zhengzhou University, Henan Normal University and Henan Academy of Sciences, with Genuine Biotech owning the independent intellectual property rights. Currently in China, there are another three COVID19 therapies on top of azvudine–Paxlovid which was approved this February, and two investigational drugs, VV116 and FB2001. As China’s first ever homegrown COVID antiviral, azvudine is expected to get into a market with great potential.

On the same day, Fosun Pharma announced strategic partnership with Genuine Biotech and secured the exclusive rights to commercialize the COVID19 therapy in China with a down payment of about 800 million yuan.

In terms of marketing applications, China NMPA accepted 6 NDAs last month, including Roche’s Phesgo, Hengrui Medicine’s SHR8554 for injection, Zai Lab’s Vyvgart, deucravacitinib tablets by BMS, etc.

Phesgo is a subcutaneous fixed-dose combination of trastuzumab, pertuzumab, and hyaluronidase to treat all stages of HER2-positive breast cancer in combination with chemotherapy. It’s the first time two monoclonal antibodies are combined and delivered by utilizing Halozyme's ENHANZE® technology, which can be administered over only 5 to 8 minutes. Roche filed new drug application for the combination in China, and was accepted on July 27. In the US and the Europe, marketing authorization was granted to Phesgo for early and metastatic HER2-positive breast cancer in June and November 2020, respectively.

On July 8, Hengrui Medicine received NDA acceptance for its SHR8554 for injection to be used for postoperative pain after abdominal surgery. The treatment, a selective biased μ-opioid receptor agonist, is a Class I new drug independently developed by Hengrui, which is able to reduce the incidence of the common side-effects of MOR agonists, such as reduced gastrointestinal motility. In China, there is currently no approved biased MOR agonists with strong analgesic effects and few adverse events, which indicates huge unmet clinical needs. The most advanced therapy of this kind is Olinvyk licensed from Trevena to Nhwa Pharmaceutical, whose NDA application was accepted by China NMPA this January.

On July 14, Zai Lab announced the NDA acceptance in China for Vyvgart in generalized myasthenia gravis. Vyvgart is an antibody fragment designed to target the neonatal Fc receptor. In January 2021, Zai Lab obtained the exclusive rights from argenx to develop and commercialize the drug in Greater China. According to Zai Lab, Vyvgart is the first and only FcRn antagonist approved in the US and Japan for the treatment of generalized myasthenia gravis in adults. In China, it’s also the one closest to approval among all the FcRn-targeting candidates being clinically developed.

On July 15, the China NMPA has officially accepted the investigational plaque psoriasis drug, deucravacitinib for review. Deucravacitinib is Bristol Myers Squibb's first independently developed oral, selective TYK2 inhibitor. In November 2021, the US FDA accepted the marketing application for the drug for the treatment of moderate to severe plaque psoriasis in adults and assigned a target action date of September 10, 2022. If approved, deucravacitinib would be the first TYK2 inhibitor approved for the treatment of any disease.

Finally, apart from the transaction mentioned earlier about the COVID19 antiviral azvudine between Genuine Biotech and Fosun Pharma, here’s another two pharma deals.

On July 26, Kelun Biotech announced its second deal with Merck, the US pharma giant, who has secured global rights to an investigational CLDN 18.2-targeting ADC, SKB315, for $35 million upfront and up to $901 million in milestones. The partners will also collaborate on early clinical development of the drug candidate.

Another is the exclusive license agreement between the CSPC Pharmaceutical Group and Elevation Oncology announced on July 28 for the development and commercialization of SYSA1801, which is also an anti-CLDN18.2 ADC. Elevation Oncology will develop and commercialize SYSA1801 in all global territories outside of Greater China, with its $27 million payout and further milestone payments to CSPC.

Alright, that’s everything for last month. For any questions or suggestions, please feel free to contact us. I’ll see you next time!