Luye’s Strengthened CNS Portfolio: Pivotal Study for Rivastigamine Multi-Day Transdermal Patch Completed in Germany

Luye Pharma Group announced today that the pivotal study for Rivastigamine Multi-Day Transdermal Patch (Rivastigamine MD), an innovative delivery system drug for the treatment of Alzheimer’s disease, has been completed in Germany. Developed on the transdermal drug delivery platform by Luye Pharma AG, the Group's subsidiary in Germany, Rivastigamine MD is a core product in Luye Pharma’s Central Nervous System (CNS) portfolio. Another product in this category is Rivasigamine Single-Day Transdermal Patch, which has to date been marketed in more than 20 countries around the world and will be brought to China in the second half of this year.

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Luye Pharma and PharmaMar Sign Licensing Agreement for the Development and Commercialization of Zepsyre® in China

On April 26, Luye Pharma Group announced an agreement with Pharma Mar S.A (“PharmaMar”) to develop and commercialize a Phase III new innovative anti-cancer drug: Zepsyre® (Lurbinectedin).

According to the terms of the agreement, Luye Pharma will have exclusive rights to develop and commercialize Zepsyre® for Small Cell Lung Cancer and all other indications in China. In addition, Luye Pharma will have the right to request transfer of manufacturing technology for Zepsyre® to the company in China for the duration of the agreement.

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Luye Life Sciences Donations for Setting up “SJTU School of Medicine Luye Management Service Award Fund”

On April 18, Luye Life Sciences Group and Shanghai Jiaotong University (SJTU) School of Medicine entered into an agreement to make donations to set up “SJTU School of Medicine Luye Management Service Award Fund”. The fund aims to fully implement education policy of the Party and to work on the spirit of “never stop exploration of medical principles”, encourage excellent management service personnel in medical education, who are diligent and skilled with a high management level, cultivate the spirit of carrying out research and pursuing excellence and further promote the development of medicine.

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Luye Pharma Group Invests in Exicure for the Development of Novel Nucleic Acid Therapeutics

Luye Pharma Group announces a US $5 million (approximately 33 million RMB) equity investment in Exicure, Inc. for the research and development of novel nucleic acid therapeutics.

Exicure, Inc., based in Skokie, Illinois, USA, is a clinical stage biotechnology company developing a new class of immunomodulatory and gene silencing drugs against validated targets. Exicure’s 3-dimensional, spherical nucleic acid (SNA™) architecture seeks to unlock the potential of nucleic acid therapeutics in multiple organs. Exicure’s lead programs address diseases from inflammatory disorders to oncology.

"The promise of nucleic acid therapeutics, which target the underlying genetic source of disease, is here today with recent approvals and clinical successes,” said Dr. David Giljohann, Chief Executive Officer of Exicure. “Toxicity and delivery have been the primary challenge for companies seeking to incorporate nucleic acids into drug development. We have shown that our SNA technology can overcome these challenges and change the cost curves and development timelines in making these highly targeted medicines. We are advancing a pipeline of drugs for a broad range of chronic conditions and orphan diseases in dermatology, ophthalmology, lung, gastric disorders, and solid tumor cancers. We welcome Luye Pharma as an investor in Exicure as they bring great insight into rapidly emerging markets for our products."

Luye Pharma Partners with ELPIS BIOPHARM on CAR-T Therapy in Drive to Develop Immuno-oncology Offerings

Luye Pharma has recently been very active in developing its global product pipelines focused on immune-oncology.

On May 28, Luye Pharma announced the company would be entering into a collaborative and a licensing agreement with Elpis Biopharmaceuticals Corp. (Elplis Biopharm), a biotechnology company based in Boston, U.S., to discover and develop dual-targeted Chimeric Antigen Receptor T-cell (CAR-T) therapies and biological drug candidates for the next-generation immune-oncology treatments.

The cooperative agreement will take Luye Pharma a step closer towards global deployment in immune-oncology. Enrichment of the anti-tumor product pipeline will continue to strengthen the company's leading position in this therapeutic field, as well as lay solid foundations for rapid expansion into the global market.

Elpis Biopharm is a company committed to applying cutting-edge technologies to develop fully human antibodies and innovative drugs for immune-cell therapy. Under the cooperative agreement, Elpis Biopharm will use its proprietary antibody discovery and development platforms to generate the next generation of leading CAR-T candidates for targets specified by the two collaborating parties. The most advanced next-generation dual-targeted CAR-T cell therapeutics derived from this collaboration is currently in the IND-Enabling preclinical study phase; Luye Pharma is responsible for China-territory development and commercialization of all therapy candidates arising from this cooperation.

AstraZeneca has entered into an agreement with Luye Pharma Group, Ltd. (Luye Pharma) for the sale and licence of the rights to Seroquel and Seroquel XR in the UK, China and other international markets, including Brazil, Australia, Saudi Arabia, Mexico, South Korea, Thailand, Argentina, Malaysia and South Africa.

The transaction is part of AstraZeneca’s strategy to focus on its three main therapy areas of Oncology, Cardiovascular, Renal & Metabolism and Respiratory.

Seroquel, used primarily to treat schizophrenia and bipolar disease, has lost its compound patent protection globally; the Seroquel XR formulation patents have now also expired in the vast majority of markets. AstraZeneca partnered the rights to Seroquel and Seroquel XR in Japan and Venezuela under prior agreements.

Mark Mallon, Executive Vice President, Global Product and Portfolio Strategy, AstraZeneca, said: "The agreement with Luye Pharma is in line with AstraZeneca’s strategy to focus on three main therapy areas while maximising the value from our legacy medicines like Seroquel. The agreement with Luye Pharma will also ensure continued widespread patient access to important established medicines."

Dr. Yehong Zhang, head of Luye Pharma (International) said: "Central nervous system diseases continue to present a challenge to patients and healthcare systems across the world. This transaction represents another step in our effort to build a portfolio and platform to help address this issue. It is an affirmation of our commitment to accelerate our international presence. We look forward to strengthening our relationship with existing and future partners and making this a success for us and for patients in need."

Luye Pharma has entered into a collaboration and license agreement with Excel BioPharma LLC, a California Biotechnology company, to collaborate on the discovery and development of therapeutic antibodies for next generation immuno-oncology treatments.

Excel BioPharm will utilize its proprietary rabbit monoclonal antibody platform to screen and discover antibodies for targets specified by the Group, so as to diversify the group's product line of biological drugs in related therapeutic areas.

The group will be responsible for the global development and commercialization of all leading drug candidates based on results of the collaboration.

Excel BioPharm's antibody platform generates a series of antibodies with high specificity, high affinity and unique epitope recognition, and can develop antibodies against difficult targets. Luye Pharma believes that such features will efficiently increase the probability of developing 'best-in-class' therapeutic antibodies.