Takeda China Merges Two Key Product Lines in Gastroenterology Portfolio

[April 7, 2022/Medical News at a Glance] ViGeneron partners with Regeneron to develop a new generation of ophthalmic gene therapies; HBM7022 out-licensing agreement signed between Harbour BioMed and AstraZeneca; Henlius' PD-1 inhibitor for the treatment of small cell lung cancer granted Orphan Drug Designation by FDA... For the latest pharmaceutical news and medical information, PharmaExpress invites you to stay tuned!

Policy Brief

Guangdong Alliance's Online Bidding for Traditional Chinese Medicine Procurement to Begin on April 8

On April 6, the Guangdong Province Pharmaceutical Trading Center released a notice regarding the launch of online bidding for the Guangdong Alliance's bulk procurement of traditional Chinese medicines such as Qingkailing. The bidding time is from 9:00 AM to 12:00 PM (Beijing Time) on April 8, 2022 (Friday). The Guangdong Traditional Chinese Medicine Alliance, consisting of Guangdong, Shanxi, Henan, Hainan, Ningxia, and Qinghai, forms a procurement alliance to carry out bulk procurement for 132 drugs with large usage volumes and high procurement amounts within the national basic medical insurance drug directory. (Guangdong Province Pharmaceutical Trading Center)

Industry Observation

Takeda China Merges Two Major Product Lines

On the 6th, Takeda Pharmaceutical China confirmed the news that Pantoprazole Sodium Enteric-Coated Tablets and Vonoprazan Fumarate Tablets will merge their product lines. Takeda China stated that this product line adjustment does not involve significant personnel changes. The reason for the adjustment is mainly to better respond to the market environment, hoping for closer cooperation in this aspect moving forward. This adjustment represents Takeda's repositioning in its key gastroenterology sector. (CPhI China)

Betta Pharmaceuticals' Net Profit in 2021 was 383 Million Yuan, a Year-on-Year Decrease of 36.83%

On the 6th, Betta Pharmaceuticals announced its 2021 annual report. The company achieved an operating income of 2.246 billion yuan in 2021, a year-on-year increase of 20.08%; net profit attributable to shareholders of 383 million yuan, a year-on-year decrease of 36.83%; R&D investment of 861 million yuan, accounting for 38.32% of revenue; basic earnings per share of 0.92 yuan, a year-on-year decrease of 38.67%. The company will distribute a cash dividend of 2.50 yuan (including tax) for every 10 shares to all shareholders. (Sina Medicine News)

MedChem 2021 Net Profit Increased by 118% Year-on-Year

On the 6th, MedChemElite released its 2021 annual report, showing revenue of 1.167 billion yuan, a year-on-year increase of 75.28%; net profit attributable to shareholders of 282 million yuan, a year-on-year increase of 118.12%; non-recurring net profit of 271 million yuan, a year-on-year increase of 119.53%; basic earnings per share of 4.55 yuan. The company plans to distribute a cash dividend of 13.7 yuan per 10 shares (including tax) to all shareholders. (Sina Medicine News)

Kangzhi Pharmaceutical's Net Profit Increased by 17.65% Year-on-Year in 2021

Recently, Kangzhi Pharmaceutical released its annual report for 2021. During the reporting period, the company achieved operating revenue of 837 million yuan, a year-on-year decrease of 9.23%; net profit attributable to shareholders of listed companies was 10.99 million yuan, a year-on-year increase of 17.65%; basic earnings per share were 0.0244 yuan, a year-on-year increase of 17.31%. (Sina Medicine News)

Huiyu Pharmaceutical's revenue in 2021 increased by 33.69% year-on-year

On the 6th, Huiyu Pharmaceutical released its annual report for 2021. The company achieved operating revenue of 1.824 billion yuan, a year-on-year increase of 33.69%; net profit attributable to shareholders of listed companies was 446 million yuan, a year-on-year increase of 29.87%; net profit attributable to shareholders of listed companies excluding non-recurring gains and losses was 410 million yuan, a year-on-year increase of 26.22%; basic earnings per share were 1.2 yuan, a year-on-year increase of 26.32%. The company will distribute a cash dividend of 2.11 yuan (including tax) for every 10 shares to all shareholders. (Sina Medicine News)

Dongyangguang: Q1 net profit up 1149% to 1287% year-on-year

On April 7, Dongyangguang announced that the company expects the net profit attributable to shareholders of listed companies in the first quarter of 2022 to increase by 2.5 billion to 2.8 billion yuan compared with the same period last year, representing a year-on-year increase of 1148.99% to 1286.86%. During the reporting period, the sales volumes of the main products in the three major sectors of electronic new materials, alloy materials, and chemical products all increased significantly. The core products saw both volume and price increases, leading to a substantial growth in the company's performance compared to the same period last year. (Corporate Announcement)

Tianyi Medical's ChiNext IPO Opens Below Issue Price, Closes Up 20.93%

On April 7, Tianyi Medical landed on the ChiNext Board with an issue price of 52.37 yuan per share. It opened below the issue price at 49.98 yuan per share, a drop of 4.56% from the issue price. However, not long after, Tianyi Medical "turned the situation around," surged in a straight line, triggering a temporary suspension. The highest price reached 75 yuan per share, up 43.21%. As of today's closing, Tianyi Medical was at 63.33 yuan per share, up 20.93%, with a total market value of 3.733 billion yuan. (Sina Medicine News)

MSD Expands Production Facilities to Increase HPV Vaccine Supply

Recently, MSD announced that the company has made substantial investments in production. It recently expanded its vaccine manufacturing facility located in Elkton, Virginia, USA. Upon regulatory approval, the construction added 120,000 square feet of space and created 150 new jobs, further enhancing the company’s production and supply capacity for the HPV vaccine. MSD expects that as the company continues to expand the capacity of its existing facilities and bring new ones online, its HPV vaccine supply will double again between 2020 and 2023. (Sina Medicine News)

ViGeneron Partners with Regeneron to Develop Next-Generation Ophthalmic Gene Therapies

Recently, gene therapy company ViGeneron announced a research and development collaboration agreement with Regeneron targeting a specific antigen. The two parties will develop and commercialize a gene therapy for a hereditary retinal disease based on ViGeneron’s engineered recombinant adeno-associated virus vector. (WuXi AppTec)

HBM7022 Out-License Agreement Signed Between Harbour BioMed and AstraZeneca

On the 7th, Harbour BioMed announced that the company had entered into an out-licensing agreement with AstraZeneca for the development and commercialization of the bispecific antibody HBM7022. According to the agreement, AstraZeneca will obtain a global exclusive license for the research, development, registration, manufacturing, and commercialization of HBM7022 and will be responsible for all costs related to the further preclinical development and commercialization of HBM7022. Harbour BioMed will receive a $25 million upfront payment, up to $325 million in milestone payments, as well as royalties based on future HBM7022 sales. (Corporate Announcement)

Everest Medicines and CR Pharmaceutical Reach Cooperation on mRNA Vaccine Business, Plan to Establish Independent Company

Today, Everest Medicines announced that it has signed a memorandum of cooperation with China Resources Pharmaceutical Group Limited to establish an independent company focused on the discovery, development, and commercialization of mRNA vaccines. In addition, China Resources Pharmaceutical Group plans to make a strategic equity investment in Everest Medicines' mRNA technology platform. (Sina Medicine News)

Pharmaceutical News and Medical Information

FDA Approves Novartis PI3K Inhibitor

On the 6th, Novartis announced that the U.S. FDA granted accelerated approval to Vijoice (alpelisib) for the treatment of PIK3CA-Related Overgrowth Spectrum (PROS) in adult and pediatric patients aged 2 years and older who require systemic therapy and exhibit severe manifestations. The press release noted that Vijoice is the first PROS-targeted treatment approved by the U.S. FDA, addressing the underlying cause of the disease in specific patients. (WuXi AppTec)

Igalmi Sublingual Film Approved for Marketing

Today, BioXcel Therapeutics announced that the U.S. FDA has approved Igalmi (dexmedetomidine) sublingual film for the acute treatment of agitation associated with schizophrenia or bipolar I/II disorder. The press release noted that this is the first FDA-approved orally dissolving sublingual film for treating mild, moderate, or severe agitation in this patient population. (WuXi AppTec)

Huahai Pharmaceutical's Linagliptin and Metformin Hydrochloride Tablets Receive Tentative Approval from U.S. FDA

On the 7th, Huahai Pharmaceutical announced that the company's Abbreviated New Drug Application (ANDA, i.e., U.S. generic drug application) for Linagliptin Metformin Hydrochloride Tablets submitted to the U.S. FDA has received tentative approval. (Corporate Announcement)

Henlius' PD-1 Inhibitor for the Treatment of Small Cell Lung Cancer Granted Orphan Drug Designation by FDA

On the 7th, Henlius announced that its self-developed PD-1 inhibitor H drug Hansizhuang (Seriulimab) has been granted orphan drug designation by the U.S. FDA for the treatment of small cell lung cancer. (Sina Medicine News)

Huahai Pharmaceutical's Levetiracetam Injection Concentrate Receives Drug Registration Certificate

On the 7th, Huahai Pharmaceutical announced that the company had recently received the "Drug Registration Certificate" for Levetiracetam Injection Concentrate issued by the National Medical Products Administration. (Corporate Announcement)

Hainan Better's Voriconazole for Injection Approved for Production and Considered to Have Passed the Evaluation

On the 6th, the official website of the National Medical Products Administration showed that Hainan Better Pharmaceutical Co., Ltd. received approval for the production of Voriconazole for Injection, submitted as a Category 4 generic drug, and it was considered to have passed the evaluation, making it the fifth domestically produced version in China. Voriconazole is a broad-spectrum triazole antifungal agent that inhibits 14α-sterol demethylation mediated by cytochrome P450 in fungi, thereby suppressing ergosterol biosynthesis and ultimately leading to fungal cell death. (National Medical Products Administration)

Yangtze River Pharmaceutical Group Secures First Generic of Super Antibiotic

On the 6th, the official website of the National Medical Products Administration (NMPA) showed that Yangtze River Pharmaceutical's Category 4 generic drugs, Tedizolid Phosphate for Injection and Levetiracetam Tablets, were approved for production and considered to have passed the evaluation. The Tedizolid Phosphate for Injection is the first generic version. Tedizolid Phosphate is a derivative of Linezolid and is a second-generation oxazolidinone antibiotic. Levetiracetam is a pyrrolidone derivative that can be used as an add-on treatment for partial seizures in adult and pediatric epilepsy patients over 4 years old. (National Medical Products Administration)

Hotgen Biotech's COVID-19 Antigen Test Kit (Anterior Nasal) Receives Certification from Hong Kong Government Health Department

On the 7th, Hotgen Biotech announced that its product, "Hotgen Biotech Beijing Novel Coronavirus 2019-nCoV Antigen Test Kit (Anterior Nasal)," has received certification from the Hong Kong Government Department of Health. (Corporate Announcement)

Baike Biotech's Shingles Attenuated Live Vaccine Proposed for Priority Review

On the 7th, the CDE official website showed that the varicella-zoster vaccine (live, attenuated) produced by Baike Biotechnology is proposed to be included in the priority review for the prevention of herpes zoster. (CDE)

Kelon Pharmaceutical's Medium and Long Chain Fat Emulsion/Amino Acids (16)/Glucose (30%) Injection to Be Approved Soon

Recently, the official website of the National Medical Products Administration (NMPA) showed that the Medium and Long Chain Fat Emulsion/Amino Acids (16)/Glucose (30%) Injection reported by Sichuan Kelun Pharmaceutical for generic drug category 3 has entered the administrative approval stage. The domestic market for this product is currently vacant. (NMPA)

AstraZeneca Announces Phase III Trial Data for Long-Acting C5 Inhibitor in gMG

Recently, AstraZeneca announced the long-term follow-up results from the open-label extension phase of the Phase III CHAMPION-MG trial. The data showed that: In adult patients with generalized myasthenia gravis who are positive for anti-acetylcholine receptor antibodies, the long-acting C5 complement inhibitor Ultomiris (ravulizumab) demonstrated long-term efficacy. During the 60-week treatment period, patients experienced improvements in activities of daily living, muscle strength, and quality of life. Throughout the analysis, Ultomiris was well tolerated. (Sina Medicine News)

Positive Results from Pivotal Phase 3 Clinical Trial of IL-2 Receptor-Targeted Therapy for Cutaneous T-Cell Lymphoma

Today, Citius Pharmaceuticals announced positive topline results from the pivotal Phase 3 clinical trial of its investigational therapy I/ONTAK (E7777) for the treatment of patients with persistent or relapsed cutaneous T-cell lymphoma (CTCL). I/ONTAK is an engineered IL-2 diphtheria toxin fusion protein. Based on these positive results, the company anticipates submitting a Biologics License Application (BLA) to the U.S. FDA in the second half of this year. (WuXi AppTec)

Huadong Medicine's Controlled Subsidiary's DR10624 Injection Approved for Clinical Trials in New Zealand

On the 7th, Huadong Medicine announced that its controlling subsidiary, Daor Biologics, had received final approval from New Zealand's Medicines and Medical Devices Safety Authority and the Health and Disability Ethics Committee to conduct a Phase I clinical trial of injectable DR10624 locally for the treatment of type 2 diabetes, obesity, metabolic syndrome, etc. (Corporate Announcement)

Europe Delays Second Booster Shot for People Aged 80 and Under

European drug regulators and vaccine expert advisors recently stated that it may be premature to administer a fourth booster dose of the Pfizer or Moderna mRNA COVID-19 vaccine in the general population at this stage. (Sina Medicine News)