September 12, 2024 6:00 am EDT

Shanghai, China, September 12,2024 —— Organon China, a healthcare company with a focus on women’s health, today announced that it has entered into license and supply agreements with Shanghai Bao Pharmaceutical and its wholly-owned subsidiary Suzhou Centergene Pharmaceuticals, acquiring the exclusive commercialization rights to its investigational asset, SJ02, in China Mainland.

SJ02, developed by Centergene, a wholly-owned subsidiary of BaoPharma, is a long-acting recombinant human follicle-stimulating hormone carboxyl-terminal peptide fusion protein (FSH-CTP) designed for controlled ovarian stimulation (COS) in combination with a gonadotropin-releasing hormone (GnRH) antagonist to facilitate the development of multiple follicles in women undergoing assisted reproductive technology (ART) programs.

Positioned to potentially become the first long-acting FSH available in China, SJ02 is currently under review by China’s regulatory agency. The current COS regimen in ART requires daily FSH injections until the day of hCG administration. SJ02 is designed to initiate and maintain follicular growth in the ovaries for one week. If approved, a single-dose injection of SJ02 has the potential to offer an alternative to the current treatment regimen.

“As a company who focuses on health of women, Organon has extensive experience and a widely recognized portfolio in reproductive health, and we are also committed to increasing our investment in reproductive technology innovation,” said Zafer Unluer, President of Organon China. “This partnership aligns perfectly with our ‘In China, for China’ strategy and our broader growth strategy focused on expanding our fertility portfolio. We believe that by collaborating with China’s leading innovators, we can accelerate advancements in ART, offering additional fertility options to millions of Chinese families.”

According to the World Health Organization’s report ‘Estimates of Infertility Prevalence (1990-2021)’, approximately 17.5% of the global population—about one in six people—are affected by infertility, with the prevalence continuing to rise.[1]

ART refers to any procedure that involves either in vitro fertilization (IVF), or intrauterine insemination (IUI). IVF involves cycles of controlled ovarian stimulation treatment.

Liu Yanjun, Chairman of BaoPharma, said, “Through the collaboration with Organon, we believe that, if approved, SJ02, will have the potential to benefit those suffering from infertility in China, offering a new treatment option to those in need. BaoPharma remains dedicated to the innovative development of recombinant protein drugs and cutting-edge therapies. We look forward to our partnership with Organon to help deliver therapies that address urgent clinical needs to patients.”

According to the terms of the agreement, BaoPharma and its wholly-owned subsidiary Centergene will receive a $12 million upfront payment with additional development and commercial milestone payments.

About SJ02

Follicle-stimulating hormone (FSH) is a glycoprotein hormone produced and secreted by the basophilic cells of the anterior pituitary gland. In males, it promotes the development of spermatogenic epithelium, the initiation of sperm production, and sperm maturation. In females, it stimulates follicular development and maturation, works together with luteinizing hormone to prompt mature follicles to secrete estrogen and ovulate, and is involved in the formation of normal menstrual cycles. For patients undergoing superovulation or assisted reproductive technologies, FSH can stimulate the development of multiple follicles.

SJ02 (FSH-CTP) is an investigational asset that is a long-acting form of FSH with modified glycosylation sites. It does not alter its biological activity but has a prolonged half-life, 2-3 times longer than that of FSH.

About Organon

Organon is an independent global healthcare company with a strategy to help improve the health of women throughout their lives. Organon’s diverse portfolio offers more than 60 medicines and products in women’s health, biosimilars, and a large franchise of established medicines across a range of therapeutic areas. In addition to Organon’s current products, the company invests in innovative solutions and research to drive future growth opportunities in women’s health and biosimilars. In addition, Organon is pursuing opportunities to collaborate with biopharmaceutical partners and innovators looking to commercialize their products by leveraging its scale and agile presence in fast growing international markets.

Organon has a global footprint with significant scale and geographic reach, world-class commercial capabilities, and approximately 10,000 employees with headquarters located in Jersey City, New Jersey.

About SHANGHAI BAO PHARMACEUTICALS CO., LTD.

BaoPharma is a technology-driven pharmaceutical company focusing on synthetic biology-based industrialization platforms to develop biology products of significant clinical value, which conventional genetic engineering struggles to express.

As the legal entity of the Shanghai Synthetic Biology Industry Association, BaoPharma specializes in innovating and advancing the Recombinant Enzyme Clinical Application Platform, high-volume subcutaneous infusion platform for various medications, novel therapies for autoimmune diseases and organ transplantations, as well as solutions for the Assisted Reproduction Field. 

Guided by the vision of “acting on the needs of patients”, BaoPharma remains committed to bringing affordable products that can meet the needs of the general public, positioning itself as the pioneer drug product by synthetic biology who can eventually replace the old industry of biochemically extracted medicines.

About SUZHOU CENTERGENE PHARMACEUTICALS CO., LTD.

Centergene was founded in 2014, who is a wholly-owned subsidiary of BaoPharma. Centergene focuses on recombinant protein drugs, and its self-developed SJ02 (FSH-CTP) has filed for BLA.

Cautionary Note Regarding Forward-Looking Statements

Except for historical information, this press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about the potential benefits of Organon’s license agreement with Suzhou Centergene Pharmaceuticals. Forward-looking statements may be identified by words such as “foresees” “expects,” “intends,” “anticipates,” “plans,” “believes,” “seeks,” “estimates,” “will” or words of similar meaning. These statements are based upon the current beliefs and expectations of Organon’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include, but are not limited to, weakening of economic conditions that could adversely affect the level of demand for SJ02; any delay or failure to obtain regulatory approval for SJ02; and the other factors described in Organon’s filings with the Securities and Exchange Commission (“SEC”), including Organon’s most recent Annual Report on Form 10-K and subsequent SEC filings, available at the SEC’s Internet site (www.sec.gov). Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

References and links to websites have been provided for convenience, and the information contained on any such website is not a part of, or incorporated by reference into, this press release. Organon is not responsible for the contents of third-party websites.

¹ Infertility Prevalence Estimates 1990-2021, World Health Organization