XTALPI Advances Toward Hong Kong Listing Amid National Healthcare Crackdown on Industry Malpractices
XtalPi
Computation-Driven Innovative Drug R&D Provider
Source: 21st Century Economic Report
●China's National Health Commission Leads Release of Notice to Standardize Pharmaceutical Production and Circulation Order, Correcting Industry Irregularities
On May 27, the National Health Commission, leading with 14 ministries jointly issued the "Notice on Printing and Distributing the Key Points of Correcting Unethical Practices in the Pharmaceutical Purchase and Sales Field and Medical Services in 2024" (hereinafter referred to as the "Notice"). The Notice explicitly states that it is necessary to continuously standardize the order of pharmaceutical production and circulation, focus on rectifying unethical practices and corruption issues close to the public, resolutely correct industry malpractices, effectively safeguard the security of medical insurance funds, and deepen and consolidate the effectiveness of centralized rectification efforts. Specific measures include: continuously standardizing the order of pharmaceutical production and circulation, focusing on rectifying unethical practices and corruption issues close to the public, resolutely correcting industry malpractices, effectively safeguarding the security of medical insurance funds, and deepening and consolidating the effectiveness of centralized rectification efforts, comprising a total of 5 parts and 15 items.
● Eisai's Lecanemab Launched in South Korea
On May 27, Eisai and Biogen announced that the South Korean Ministry of Food and Drug Safety (MFDS) has approved the marketing of lecanemab (Chinese generic name: Lecanemab), a humanized anti-soluble amyloid-beta (Aβ) monoclonal antibody, for the treatment of adults with early (mild) Alzheimer's disease or mild cognitive impairment caused by Alzheimer's disease. According to Eisai's press release, this is the fourth country where lecanemab has been approved for marketing, following the United States, Japan, and China.
●Fludrocortisone Acetate Tablets Approved for Marketing
On May 27, Aspen's fludrocortisone acetate tablets received approval from the China National Medical Products Administration (NMPA) for the treatment of salt-losing congenital adrenal hyperplasia (CAH) and salt-losing primary chronic adrenal insufficiency (Addison's disease).
●Pemcoritamab Achieves Primary Endpoint and All Key Secondary Endpoints in Phase 3 Clinical Study
On May 28, Innovent Biologics announced that its self-developed recombinant anti-interleukin-23p19 subunit (IL-23p19) antibody injection, Picankibart, achieved the primary endpoint and all key secondary endpoints in a Phase 3 clinical study (CLEAR-1) conducted among Chinese patients with moderate to severe plaque psoriasis. In this study, the primary endpoint (PASI90 at week 16) exceeded 80%, and during the maintenance period, Picankibart can be administered once every 12 weeks, with an estimated annual dosing frequency of only 5 to 6 times. Innovent Biologics plans to submit a new drug application for Picankibart for the treatment of psoriasis to the National Medical Products Administration (NMPA) of China.
●Marketing Application for Dulaglutide Injection Biosimilar Accepted
On May 28, Boan Biotech announced that the marketing application (BLA) for its self-developed dulaglutide injection biosimilar (BA5101) has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China, intended for glycemic control in adult patients with type 2 diabetes. BA5101 is a biosimilar of Trulicity, and the international registration and clinical trials for this product are also advancing concurrently.
Drug and Device Approval
●Safedecode Completes Series C Financing
Recently, SaphirGen (Beijing) Gene Technology Co., Ltd. has completed a C-round financing of 100 million RMB. This round of financing was led by Jinjiang Development Group, with investments from Zhongxi Fund and some existing shareholders. The funds will mainly be used to promote the co-construction of hospital LDT laboratories, accelerate the implementation of comprehensive solutions for genetic/rare diseases in top medical institutions, expedite the research, development, and registration of products for the three-level prevention and control of birth defects, furthering the group’s integrated strategy in precise prevention, control, and treatment of genetic/rare diseases.
●XtalPi Holdings Limited Is About to Go Public
On May 26, 2024, the Hong Kong Stock Exchange (HKEX) website showed that XtalPi Holdings Limited (hereinafter referred to as: XtalPi) has passed the HKEX listing hearing and is about to go public, with CITIC Securities as the sponsor. The PharmaCube InvestGo investment and financing database shows that XtalPi has completed six rounds of financing previously, with a total financing amount exceeding 5 billion yuan. Its investors include top venture capital firms and corporate venture capitals (CVCs) from both China and abroad.
Moreover, on May 27, XtalPi announced that it had recently reached a strategic cooperation with the Shanghai Branch of SPDB and SPD International. The three parties signed a letter of intent for credit cooperation with a total amount of up to 5 billion RMB and exchanged views on various businesses such as fund management, group credit, and ecosystem incubation.
●Yilian Biotech and BioNTech Forge New Strategic Partnership
On May 27, Yilian Biotech announced a new strategic collaboration with BioNTech. BioNTech will leverage Yilian Biotech’s TMALIN® ADC technology platform to develop ADC products targeting several predefined cutting-edge innovative targets. As part of the agreement, Yilian Biotech will have the right of first refusal for future collaborations if BioNTech seeks to out-license or transfer these ADC products in any one or more regions of Greater China (Mainland China, Hong Kong, Macao, and Taiwan). Under the terms of the new agreement, Yilian Biotech will receive an upfront payment of $25 million and is eligible to receive up to $1.8 billion in development, regulatory, and commercialization milestone payments, as well as tiered royalties based on global annual net sales in the future.
Industry Highlights
●New Therapy May Offer Long-Term Relief for Allergic Asthma
On May 27, the team of Peng Min from the School of Basic Medicine, Tsinghua University, published a research paper titled "A single infusion of engineered long-lived and multifunctional T cells confers durable remission of asthma in mice" in the Nature Immunology, a sub-journal of Nature.
The study designed and developed CAR-T cells targeting the triggers of allergic reactions — 5TIF4 cells. A single injection of these CAR-T cells can durably suppress the signs and symptoms of allergic asthma in mice. This research may present a potential therapy for the long-term alleviation of allergic asthma.
