AstraZeneca Launches Linzess® (Linaclotide) for IBS-C in China at CIIE

SHANGHAI, Nov. 7, 2019 /PRNewswire/ -- On the occasion of the second China International Import Expo, AstraZeneca announced Linzess, the world's first guanylate cyclase agonist^®(Linaclotide) officially launched in mainland China. Linaclotide is a targeted medication for the treatment of adult irritable bowel syndrome with constipation (IBS-C).

Irritable Bowel Syndrome with Constipation (IBS-C) is a subtype of Irritable Bowel Syndrome (IBS). It is clinically common and characterized by recurrent episodes, with constipation as the primary feature accompanied by abdominal pain, bloating, and abdominal discomfort. In severe cases, it adversely affects patients' quality of life and social functioning.^[1]. In China, at least 14 million patients suffer from constipation-predominant irritable bowel syndrome (IBS-C).^[2]. However, this common functional disorder has never attracted public attention in China, with both awareness and diagnosis rates remaining low.^[3], and there are no more targeted therapeutic drugs available^[4]。

“IBS-C is a common chronic functional disorder of the gastrointestinal tract. Although it is a benign condition, there are limited effective and safe medications available. Hospitals at all levels anticipate the availability of novel, effective, and safe drugs for IBS.-“Treatment of C enables patients to achieve a better quality of life,” stated Professor Tang Chengwei, Director-Designate of the Chinese Society of Gastroenterology of the Chinese Medical Association and Professor in the Department of Gastroenterology at West China Hospital, Sichuan University.

“Irritable bowel syndrome (IBS) predominantly affects young and middle-aged adults, who often lead fast-paced lives and have irregular eating habits. In contrast, constipation-predominant irritable bowel syndrome (IBS-C) is more prevalent among female patients,” stated Professor Hou Xiaohua, Director of the Department of Gastroenterology at Wuhan Union Hospital and Head of the Gastrointestinal Functional Disorders Collaborative Group under the Chinese Society of Gastroenterology, Chinese Medical Association. “A significant number of patients with constipation symptoms self-medicate by purchasing laxative products. Some of these products may contain anthraquinones, which irritate the intestinal tract. Long-term use can damage enteric nerves and even lead to melanosis coli.””

Linaclotide is a globally leading innovative drug introduced to China by AstraZeneca. Its innovative mechanism involves activating the body’s own guanylate cyclase C, thereby promoting intestinal fluid secretion and reducing visceral hypersensitivity, while simultaneously alleviating symptoms such as constipation, abdominal pain, and bloating in patients with constipation-predominant irritable bowel syndrome (IBS-C). As linaclotide acts locally within the gastrointestinal tract and is minimally absorbed into the bloodstream, it demonstrates a favorable safety profile. This September, AstraZeneca reached an agreement with Ironwood Pharmaceuticals, Inc. of the United States, securing exclusive rights for the development, manufacturing, and commercialization of linaclotide in mainland China, Hong Kong, and Macau.

“As early as 1993, when it first entered China, AstraZeneca introduced omeprazole, the world’s first proton pump inhibitor (PPI), to the Chinese market, sparing many Chinese patients with gastric ulcers and bleeding from gastrectomy and spearheading a transformation in the treatment of acid-related gastrointestinal diseases in China,” said Dong Lijun, General Manager of the Digestive and Full Portfolio Expansion Business Unit at AstraZeneca China. “After 26 years of innovation and development rooted in China’s digestive health sector, we will continue to uphold our original commitment of being ‘patient-centric,’ further introducing globally leading innovative medicines to meet the needs of Chinese patients. In the future, we will undoubtedly continue to contribute to the advancement of digestive health care in China.”

On Constipation-Predominant Irritable Bowel Syndrome (IBS-C)

Irritable Bowel Syndrome (IBS) is a common functional bowel disorder in clinical practice. Constipation-predominant irritable bowel syndrome (IBS-C) is one of its subtypes, characterized clinically by recurrent constipation accompanied by defecation-related symptoms such as abdominal pain, bloating, and abdominal discomfort. Due to its recurrent nature, IBS-C significantly impairs patients' quality of life. In China, the prevalence of IBS is as high as 6.5%, with IBS-C accounting for 15% of cases.^[1]. Currently, there is a lack of effective therapeutic drugs for IBS-C.^[3], treatment primarily involves selecting medications based on symptoms, such as antispasmodics, osmotic laxatives, and bulk-forming laxatives.

About Linaclotide

Linaclotide is a guanylate cyclase-C agonist, an innovative drug recommended by the American Gastroenterological Association (AGA) guidelines for the treatment of irritable bowel syndrome with constipation (IBS-C), and it is also a standard therapy for IBS-C (Recommendation grade: strong; Level of evidence: high).^[5]A Phase III clinical trial in China confirmed that, compared with the placebo group, linaclotide significantly alleviated IBS-C-related symptoms, with the proportion of responders achieving symptom relief more than double that of the placebo group. The therapeutic effect was evident as early as the first week of treatment, and patients experienced symptom improvement throughout the entire treatment period.^[3]. Furthermore, as linaclotide acts locally in the intestine with negligible systemic absorption, it demonstrates a more favorable safety profile. Studies have shown that the most common adverse reactions to linaclotide are mild to moderate diarrhea, with no clinically significant sequelae observed.^[3]。

[1] Gastrointestinal Functional Disorders Collaboration Group, Society of Gastroenterology, Chinese Medical Association. Chinese expert consensus on irritable bowel syndrome (2015, Shanghai) [J]. Chinese Journal of Digestion, 2016, 36(5): 299-312.

[2] Zhang L, Duan LP, Liu YX, et al. Meta-analysis of the prevalence and related risk factors of irritable bowel syndrome in the Chinese population[J]. Chinese Journal of Internal Medicine. 2014;53(12):969-975. DOI: 10.3760/cma.j.issn.0578-1426.2014.12.011.

[3] PREVALENCE AND DIAGNOSIS RATE OF IRRITABLE BOWEL SYNDROME IN ADULT GASTROENTEROLOGY OUTPATIENTS IN CHINA: THE LINGO STUDY: 3-5

[4] Yang Y, Fang J, et al. J Gastroenterol Hepatol. 2018 33(5)

[5] Weinberg DS, et al. Gastroenterology 2014;147(5):1146-1148.