Telix Pharmaceuticals and China Grand Pharma Announce Strategic Licence and Commercial Partnership for Greater China Market

MELBOURNE, Australia and HONG KONG, Nov. 02, 2020 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, ‘Telix’, the ‘Company’) announces it has entered into a strategic licence and commercial partnership with China Grand Pharmaceutical and Healthcare Holdings Limited (‘China Grand Pharma’) for Telix’s portfolio of Molecularly-Targeted Radiation (‘MTR’) products.

Telix has appointed China Grand Pharma as its exclusive partner for the Greater China market (‘Territory’)¹ and grants China Grand Pharma exclusive development and commercialisation rights to Telix’s portfolio of prostate, renal and brain (glioblastoma) cancer imaging and therapeutic MTR products in the Territory.

Leveraging off China Grand Pharma’s capabilities and infrastructure in China, Telix will enter a significant oncology market, and by partnering with Telix, China Grand Pharma will build on its pipeline of innovative products for Greater China, as well as its strategy in Nuclear Medicine.   

The material terms of the partnership include:

Therapeutic Products

• US$25M (~AU$35M) up-front non-refundable prepayment to Telix, to be credited against future regulatory and commercial milestone payments.
  
  
• Up to US$225M (~AU$315M) in regulatory and commercial milestone payments to Telix, across Telix’s existing therapeutic products portfolio.
  
  
• Program-related investment estimated at up to US$65M (~AU$90M) for clinical costs associated with the development of the therapeutic products in the Territory, to align with Telix’s global clinical development programs.
  
  
• Royalties on therapeutic product sales in the Territory, in addition to milestone payments.
  

Imaging Products

• Exclusive commercial partnership (sales, marketing, distribution) for Telix’s core imaging product portfolio:
  
  • TLX250-CDx (⁸⁹Zr-Girentuximab) for renal cancer, and;
    
  • TLX591-CDx (⁶⁸Ga-PSMA), TLX599-CDx (⁹⁹Tc-PSMA) for prostate cancer.

• Includes minimum annual purchase obligations to maintain Territory exclusivity.
  

Strategic Equity Investment

Additionally, China Grand Pharma will make a simultaneous one-time strategic equity investment of US$25M (~AU$35M) in Telix. The investment is in the form of a private placement to China Grand Pharma of 20,947,181 fully paid ordinary Telix shares representing a post-issue holding by China Grand Pharma of 7.62%. Shares will be issued at a price of AU$1.69, based on the 10-day volume-weighted average price (‘VWAP’) for Telix shares up to and including 28^th October 2020. Shares will be issued no later than November 06 2020, following receipt of the placement proceeds. Shares issued to China Grand Pharma are subject to a holding lock and will not be able to be traded for a period of 12 months from the date of issue. In addition, China Grand Pharma is subject to a standstill provision and is unable to trade in Telix shares for a period of 12 months.

Telix Pharmaceuticals CEO, Dr. Chris Behrenbruch stated, "Telix’s mission is to be a leading global oncology company and China is an important future market for our products. We are pleased to be working with China Grand Pharma to deliver our diagnostic imaging and therapeutic products to cancer patients in China. Considering the successful acquisition of Sirtex Medical Limited with joint venture private equity partner CDH Genetech Limited² and subsequent approval of a New Drug Application filing for SIR-Spheres^® by the National Medical Products Administration (‘NMPA’) of the People’s Republic of China³, we believe that China Grand Pharma possesses the technical experience and execution infrastructure to be an ideal clinical and commercial partner for Telix in China.”

China Grand Pharmaceutical and Healthcare Holdings Executive Deputy Officer, Mr. Frank Zhou added, "China Grand Pharma has a strong commitment to oncology, including radioactive products, in China and around the globe. Grand Pharma sees nuclear medicine as the future and has a strategy to build a suite of the world's best products to service the Greater China Region, which includes mainland China, Hong Kong SAR, Macau SAR and Taiwan. We firmly believe in the potential of Telix’s product portfolio to have a significant clinical impact in China. It is an honour for us to have the right to bring Telix's unique product range to our doctors and patients with major unmet medical needs. At the same time, our close clinical involvement will help bring strength to Telix's product development and reach. We are very excited about this long-term partnership.”

About the China Opportunity  

In China, an estimated 100,000, 70,000 and 35,000 new diagnoses of prostate cancer, renal cancer and glioblastoma, respectively were made in 2018.⁴

• Prostate cancer: The prevalence of prostate cancer in China is heavily weighted to urban versus rural areas (14/100,000 versus 5/100,000, respectively) and men are first diagnosed with more advanced stage disease compared to their Western counterparts (localised; locally advanced; metastatic: 40%; 30%; 30% versus 84%; 12%; 4% in Chinese versus Western men, respectively).⁵ Consequently, there is a significant unmet need for effective prostate cancer imaging for the improved diagnosis and staging of prostate cancer in China, as well as more effective systemic therapies to address the high rate of advanced forms of the disease.
  
  
• Renal cancer: Renal cancer is the third most common urologic cancer, after prostate and bladder cancers in China, and most patients are diagnosed as incidental findings from abdominal imaging.⁶ Similar to Western countries, there are major unmet needs in China for improvement in diagnosis of renal cell carcinoma (typically the most common and aggressive form of kidney cancer) from otherwise indeterminate renal masses using PET imaging, as well as effective treatments for advanced (metastatic) forms of this disease.
  
  
• Glioblastoma: The diagnosis of glioblastoma, the most common type of primary brain cancer is typically considered incurable in China. While surgical resection plus radiation therapy are the mainstays of treatment, the vast majority of patients experience disease recurrence. Thus, there remains a major need for therapies targeted towards glioblastoma in patients in both the front-line treatment setting, as well as for patients experiencing disease recurrence following surgical intervention.⁷ 
  

About Telix Pharmaceuticals Limited

Telix is a clinical-stage biopharmaceutical company focused on the development of diagnostic and therapeutic products using Molecularly Targeted Radiation (MTR). Telix is headquartered in Melbourne, Australia with international operations in Belgium, Japan and the United States. Telix is developing a portfolio of clinical-stage oncology products that address significant unmet medical needs in prostate, kidney and brain cancer. Telix is listed on the Australian Securities Exchange (ASX: TLX). For more information visit www.telixpharma.com.

About China Grand Pharmaceutical and Healthcare Holdings

China Grand Pharmaceutical and Healthcare Holdings Limited (512.HK) is a diversified global pharmaceutical enterprise, principally engaged in research, development, manufacturing and sales of pharmaceutical products, advanced medical devices, specialized pharmaceutical ingredients, biotechnology products and nutritional products. CGP’s core product portfolio covers several major therapeutic areas including respiratory and ENT, cardiovascular emergency products and advanced medical devices, bio-technology products and nutritional products. The business is structured into four major segments: innovative medicines and medical devices with high barriers of entry; branded drugs; pharmaceutical ingredients and products; and nutritional products. For more information visit www.chinagrandpharm.com.

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¹ Territory includes mainland China, Hong Kong SAR, Macau SAR, Taiwan.
² Source: http://chinagrandpharm.com/history/
³ Source: http://www.sirtex.com/au/media/news/news-item?id=38760
⁴ Globocan 2018 http://gco.iarc.fr/today/data/factsheets/populations
⁵ Chinese guidelines for diagnosis and treatment of prostate cancer 2018 (English version) National Health Commission of the People’s Republic of China.
⁶ Globocan 2018 http://gco.iarc.fr/today/data/factsheets/populations
⁷ Chang L, et al. Treating malignant glioma in Chinese patients: update on temozolomide. OncoTargets and Therapy 2014:7 235–244.