21 Health Daily | Laike Pharma's Lead Drug Fails Phase II Trial, Shares Plunge Over 35%; Philips Exits U.S. Ventilator Market

Source: 21st Century Economic Report

●SAMR Releases Typical Cases of Anti-Monopoly Enforcement in the Field of People's Livelihood, Three of Which Involve the Pharmaceutical Industry

Recently, the State Administration for Market Regulation released the third batch of typical cases from the 2023 special campaign on anti-monopoly enforcement in the field of people's livelihood, comprising 15 typical cases, three of which involve the pharmaceuticals industry.

These three typical cases include one case of operator concentration and two cases of abuse of market dominance, involving Simcere, Shanghai Pharmaceutical First Biochemical Pharmaceutical Co., Ltd., and Jiangxi Xiangyu Pharmaceutical Co., Ltd.

In recent years, China's antitrust enforcement in the pharmaceutical industry has been continuously strengthened. The first batch of typical cases from the 2023 special campaign on antitrust enforcement in areas related to people's livelihood involved five pharmaceutical companies, which were fined tens of millions or even hundreds of millions of yuan by the State Administration for Market Regulation or local market regulation bureaus.

●GSK's Anti-Cancer Drug Omjjara Approved for Marketing in the EU

On January 29, GSK announced that the European Commission had approved the oral JAK1/JAK2 and activin A receptor type 1 (ACVR1) inhibitor Omjjara (momelotinib) for marketing.

Omjjara is the first drug approved in the EU for the treatment of adult patients with moderate to severe anemia associated with primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis, as well as disease-related splenomegaly (enlarged spleen) or symptoms. These patients are either new to Janus kinase (JAK) inhibitors or have previously been treated with ruxolitinib. The approval of Omjjara is based on the subgroup of adult patients with moderate to severe anemia (hemoglobin <10 g/dL) from the pivotal MOMENTUM Phase III trial and the SIMPLIFY-1 Phase III trial.

● Hengrui Pharma's Tacrolimus Extended-Release Capsules Approved by FDA for Marketing

On January 29, Hengrui Pharma (600276.SH) announced that its subsidiary, Chengdu Shengdi Pharmaceutical Co., Ltd., had received a notification from the U.S. Food and Drug Administration (FDA). The Abbreviated New Drug Application (ANDA, i.e., the U.S. generic drug application) for Tacrolimus Extended-Release Capsules submitted by the company to the U.S. FDA has been approved. This product is the first generic drug approved for marketing by the U.S. FDA and also the first generic product in China.

In vivo and in vitro studies have confirmed that tacrolimus is a potent immunosuppressant capable of inhibiting the production of cytotoxic lymphocytes responsible for transplant rejection, T-cell activation, T-helper-cell-dependent B-cell proliferation, the production of lymphokines (such as interleukin-2, interleukin-3, and interferon-gamma), and the expression of the interleukin-2 receptor.

● The new indication application for "miracle cancer drug" DS-8201 accepted by the FDA

On January 29, Daiichi Sankyo and AstraZeneca announced that the FDA has accepted the marketing application for Enhertu (DS-8201) for the treatment of metastatic HER2-positive solid tumors and granted it priority review status.

On February 24, 2023, the National Medical Products Administration announced that the ADC drug DS-8201 (English trade name Enhertu, Chinese trade name Youhede), jointly developed and commercialized by AstraZeneca and Daiichi Sankyo, had been granted marketing approval for the indication of HER2-positive breast cancer.

On December 20, 2019, DS-8201 was approved in the United States for the treatment of HER2-positive breast cancer. In the following four years, it was successively approved in Japan, the European Union, the United Kingdom, and other regions.

Currently, DS-8201 has been approved for 7 indications in various regions globally: HER2-mutant non-small cell lung cancer, HER2-low breast cancer, adenocarcinoma of the gastroesophageal junction, HER2-positive gastric cancer, gastric cancer, breast cancer, and HER2-positive breast cancer.

● Jiuan Healthcare expects a 91.89%-93.14% year-on-year decrease in net profit for 2023.

On January 29, Jiuan Healthcare announced that its estimated net profit for 2023 would be RMB 1.1 billion to RMB 1.3 billion, a year-on-year decrease of 91.89%-93.14%. The company stated that the decline in performance was due to reduced demand for its iHealth in vitro diagnostic testing products in the U.S. market.

● Phase 2 Clinical Trial Failure of Core Pipeline Leads to Over 35% Drop in Laekna Therapeutics' Stock Price

On January 29, Laekna Therapeutics announced the topline data of Afuresertib combined with paclitaxel in the treatment of platinum-resistant ovarian cancer (PROFECTA-II), showing that weekly Afuresertib plus paclitaxel reduced the risk of disease progression or death (progression-free survival, PFS), with a hazard ratio (HR) of 0.744 (95% CI: 0.502-1.102). However, the trial did not reach statistical significance.

Laekna Therapeutics Plans to Discuss with Regulatory Authorities on the Trial Results to Determine the Next Steps for the Registration Clinical Pathway. Detailed trial data will be presented at a medical conference.

Affected by this news, Laekna Therapeutics plummeted at the opening, closing at HK$5.00 per share, with a decline of 36.31%! The intraday low was HK$4.910, hitting another all-time historical low. Laekna Therapeutics was listed on the Hong Kong Stock Exchange under Rule 18A on June 29 last year and has now fallen below its issue price.

Afuresertib (LAE002) is the core product of Laekna Therapeutics and was introduced from Novartis in 2018. It is an adenosine triphosphate (ATP)-competitive AKT inhibitor.

● Philips Respironics Products Officially Exit the U.S. Market

The Philips respirator recall incident, which had been fermenting for three and a half years, ultimately ended with the withdrawal of multiple products from the market.

According to the product portfolio update on Philips' official website, in the United States and China, Philips Respironics will focus on the sales of consumables and accessories, including masks, and will no longer sell hospital ventilators, certain home ventilator products, portable and stationary oxygen concentrators, as well as sleep diagnostic products. As many as nine products will be discontinued starting from January 25, 2024.

In June 2021, Philips announced the recall of millions of sleep apnea and ventilator devices, stating that patients using these devices might inhale degraded foam particles and gases that could release harmful, potentially carcinogenic substances; the issue continued to escalate, and by the end of 2021, Philips had recalled 5.2 million respiratory devices globally, far exceeding the initial estimate of 3 to 4 million units.