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Simcere Enters into Partnership with Kazia Therapeutics for Paxalisib in Greater China

Release time:2021-03-30

NANJING, China, March 29, 2021 – Simcere Pharmaceutical Group Ltd (HKSE: 2096), today announces that its affiliate entered into an exclusive license agreement with Kazia Therapeutics, an Australian oncology-focused drug development company, for the development and commercialization of paxalisib across all indications in Greater China (mainland China, Hong Kong, Macau and Taiwan).

Paxalisib is a brain-penetrant inhibitor of the PI3K / Akt / mTOR pathway, currently under GBM AGILE, a global phase 2/3 adaptive platform study for glioblastoma. The New interim data analysis of Paxalisib phase II study in glioblastoma (GBM) was presented at the Society for Neuro-Oncology (SNO) Annual Meeting in November 2020. The data were consistent with previous data and showed progression-free survival (PFS) of 8.4 months (versus 5.3 months for temozolomide, the existing standard of care) and overall survival (OS) of 17.5 months (versus 12.7 months for temozolomide).

Dr. Renhong Tang, Senior Vice President of Simcere commented, “Glioblastoma is one of the most aggressive cancers with limited therapeutic options. We are tremendously excited by the potential for paxalisib to make a difference in this very challenging disease. The need for new therapies in brain cancer is significant in China, and we share Kazia’s commitment to bringing forward new treatment options for patients.”

According to the agreement, Simcere will be responsible for the clinical research, registration and commercialization of Paxalisib in Greater China. Under the terms of the agreement, Kazia will receive upfront payment, milestones and sales royalties from commercialization in Greater China.

Dr James Garner, CEO of Kazia Therapeutics added, “We are delighted to partner with Simcere to secure the commercial success of paxalisib in this critical territory. They bring to paxalisib first-class capabilities in clinical development, regulatory affairs, and commercialization. We look forward to working closely with our new partners to make paxalisib available for Chinese patients as swiftly as possible.”

About Glioblastoma

Glioblastoma (GBM) is the most common and aggressive malignant brain tumor with an incidence rate of about 3 per 100,000 persons in China. Less than 10% of patients survive more than five years. The current standard treatment for GBM includes surgery, radiotherapy and temozolomide treatment.

More than half of the GBM patients are diagnosed with unmethylated protein O (6)-methylguanine DNA methyltransferase (MGMT) promoter that have poorer prognosis. .The PI3K pathway is affected in more than 85% of GBM cases a, which appears to be a high-potential target for new GBM therapies.

About Paxalisib

Paxalisib is a brain-penetrant inhibitor of the PI3K / Akt / mTOR pathway, which is disordered in the vast majority of patients with glioblastoma, the most common and most aggressive form of primary brain cancer.

In a phase II study in patients with newly diagnosed glioblastoma with unmethylated MGMT promotor status, paxalisib has shown highly encouraging signals of clinical efficacy. In January 2021, patient recruitment commenced for paxalisib in the GBM AGILE platform study, which is expected to serve as the basis for registration in key territories.

About Simcere Pharmaceutical Group

Simcere Pharmaceutical Group (2096.HK) is rapidly transitioning to an innovation and R&D-driven pharmaceutical company, with a mission of “providing today’s patients with medicines of the future.” It has established a national key laboratory of translational medicine and innovative pharmaceuticals. Simcere focuses on oncology, central nervous system disease and autoimmune disease therapeutic areas, with a diversified product portfolio and industry-leading capabilities. Its vigorous in-house R&D efforts and extensive R&D collaborations have made it a strategic cooperation partner with world leading pharmaceutical companies and biotechnology companies, in an effort to bring more global life science breakthroughs to China.

For more information, please visit www.simcere.com.

About Kazia Therapeutics Limited

Kazia Therapeutics Limited (ASX: KZA, NASDAQ: KZIA) is an oncology-focused drug development company, based in Sydney, Australia.

Our lead program is paxalisib, a brain-penetrant inhibitor of the PI3K / Akt / mTOR pathway, which is being developed to treat glioblastoma, the most common and most aggressive form of primary brain cancer in adults. Licensed from Genentech in late 2016, paxalisib commenced recruitment to GBM AGILE, a pivotal study in glioblastoma, in January 2021. Seven additional studies are active in other forms of brain cancer. Paxalisib was granted Orphan Drug Designation for glioblastoma by the US FDA in February 2018, and Fast Track Designation for glioblastoma by the US FDA in August 2020. In addition, paxalisib was granted Rare Pediatric Disease Designation and Orphan Designation by the US FDA for DIPG in August 2020.

For more information, please visit www.kaziatherapeutics.com.

Forward Looking Statements

Information set forth in this press release contains forward-looking statements, which involve a number of known and unknown risks, uncertainties and assumptions. The forward-looking statements contained herein reflect the current judgment and views of Simcere Pharmaceutical Group Limited as of the date of this press release. Such forward-looking statements are neither promises nor guarantees but are subject to a variety of risks and uncertainties, many of which are beyond our control, or may not materialize, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements, whether as a result of new information, future events or otherwise, to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based.