Qilu Pharmaceutical's ADC Drug Approved for Clinical Trial; Cefalexin Included in Large-Scale Group Procurement by Ten Provincial Regions

[March 19, 2021 / Pharmaceutical News Overview]Ten-province (autonomous region, and Xinjiang Production and Construction Corps) alliance launches volume-based procurement for cephalexin; Da An Gene: Runhong Pharmaceutical plans to apply to the National Equities Exchange and Quotations (NEEQ) system for termination of listing; Yiling Pharmaceutical’s net profit in Q1 2021 is expected to exceed RMB 700 million; Merck’s Keytruda rejected by the UK’s NICE for the treatment of urothelial carcinoma...Daily Fresh Pharmaceutical and Medical News: Quick Reads on What Matters to You!

Part 1 Policy Brief

Volume-Based Procurement of Cephalexin by the Ten-Province (Autonomous Region and Corps) Alliance

On the 19th, the Guangdong Pharmaceutical Exchange Center issued a notice publicly soliciting opinions on the “Document for Centralized Volume-Based Procurement of Cephalexin by the Drug Alliance Regions (Draft for Comments).” The draft specifies that Guangdong, Ningxia, Henan, Qinghai, Xinjiang, the Xinjiang Production and Construction Corps, Yunnan, Guangxi, Guizhou, and Hainan will jointly conduct volume-based procurement of cephalexin. The drug subject to this centralized volume-based procurement is cephalexin, including oral immediate-release formulations, oral liquid preparations, granules, effervescent tablets, and sustained-/controlled-release formulations. All specifications under the generic name cephalexin are included in this Guangdong-led alliance procurement. The procurement cycle for this cephalexin alliance volume-based procurement extends until June 30, 2023, calculated from the actual implementation date of the selected bid results. (Guangdong Pharmaceutical Exchange Center)

Jiangsu: Implementation of the Winning Results from the Fourth National Centralized Drug Procurement on April 27

On the 19th, the Jiangsu Provincial Healthcare Security Administration issued the "Notice on Doing a Good Job in the Implementation of the Results of the Fourth Batch of National Centralized Drug Procurement." The notice pointed out that Jiangsu Province will begin implementing the prices of the winning drugs from the fourth batch of national centralized procurement starting April 27. According to the notice, Jiangsu Province will implement the results of the fourth batch of national centralized procurement across all public medical institutions and military medical institutions within the province. (Jiangsu Provincial Healthcare Security Administration)

Part 2 Industry and Economics Observation

Daan Gene: Runhong Pharmaceutical Plans to Apply for Delisting from the National Equities Exchange and Quotations System

On the 19th, Da An Gene announced that its indirectly held subsidiary, Runhong Pharmaceutical, intends to apply to the National Equities Exchange and Quotations (NEEQ) for termination of its listing. Runhong Pharmaceutical is a high-tech enterprise primarily engaged in the research and development, production, and sales of medical biological dressings in the field of wound repair. (Da An Gene Announcement)

Xianju Pharmaceutical Plans to Establish a Joint Venture with Tsinghua University and Others to Enter the Diagnostic Testing Sector

Xianju Pharmaceutical announced that, in order to effectively leverage external R&D resources and strategically position itself in the diagnostic testing sector, the company plans to invest RMB 19.6073 million, together with Tsinghua University and Quanxin Jili (Ningbo) Biotechnology Partnership (Limited Partnership), to jointly establish “Hangzhou Zijing Biotechnology Co., Ltd.” (Xianju Pharmaceutical Announcement)

CR Sanjiu’s 2020 Net Profit Reaches RMB 1.6 Billion; President Qiu Huawei’s Compensation Totals RMB 3.78 Million

On the 19th, China Resources Sanjiu’s 2020 annual report showed that during the reporting period, the company achieved an operating revenue of RMB 13,637,258,153.77, a year-on-year decrease of 7.82%; the net profit attributable to shareholders of the listed company was RMB 1,597,489,175.27, a year-on-year decrease of 23.89%. During the reporting period, the total remuneration for directors, supervisors, and senior management amounted to RMB 24.5671 million. Chairman Wang Chuncheng did not receive any remuneration from the company, while Director and President Qiu Huawei received a total pre-tax remuneration of RMB 3.7842 million from the company. (Announcement by China Resources Sanjiu)

CR Double-Crane’s 2020 Net Profit Reaches RMB 1.005 Billion; Revenue from Chronic Disease Business Declines

On the 18th, China Resources Double-Crane Pharmaceutical’s 2020 annual report showed that during the reporting period, the company achieved an operating income of RMB 8,503,938,229.78, a year-on-year decrease of 9.35%; the net profit attributable to shareholders of the listed company was RMB 1,005,161,634.08, a year-on-year decrease of 4.74%. Among them, revenue from chronic disease business decreased by 1% year-on-year, revenue from specialty business increased by 1% year-on-year, and infusion business was severely affected by the COVID-19 pandemic, with revenue decreasing by 16% year-on-year. (China Resources Double-Crane Announcement)

Yiling Pharmaceutical’s Net Profit in Q1 2021 Expected to Exceed RMB 700 Million

Yiling Pharmaceutical Recently Released Its First Quarter 2021 Earnings Forecast: Net Profit Attributable to Shareholders of the Listed Company During the Reporting Period Was RMB 656.9624 Million–RMB 700.7599 Million, Representing a Year-on-Year Increase of 50%–60%; Basic Earnings Per Share Were RMB 0.55–RMB 0.59 per Share. (Yiling Pharmaceutical Announcement)

Yatai Pharmaceutical: Judicial Sale of 27 Million Shares Held by Yatai Group and Yatai Real Estate Has Been Suspended

Yatai Pharmaceutical announced that, due to a dispute over a financial loan contract between the company’s controlling shareholder, Yatai Group, and its subsidiary Yatai Real Estate, as well as Chen Yaogen and Zhong Wanzhen, and China Minsheng Bank Co., Ltd. Shaoxing Branch, the Yuecheng District People’s Court of Shaoxing City, Zhejiang Province, conducted a public sale on its Taobao Judicial Auction Network Platform starting at 10:00 on March 7, 2021. The shares involved included 11 million shares of Yatai Pharmaceutical held by Yatai Group and 16 million shares held by Yatai Real Estate. Recently, as the applicant for enforcement withdrew their application, this judicial sale has been suspended. (Announcement from Yatai Pharmaceutical)

Chairman of WisePharma Detained Within Three Months of Taking Office

On the evening of the 17th, Raywise Medicine issued an announcement stating that its Chairman, Woo Swee Lian (Hu Ruilian), was involved in an equity dispute concerning Jilin Jifu Ginseng Biological Development Co., Ltd., a company in which he had made personal investments. He was subjected to criminal detention by public security authorities on suspicion of occupational embezzlement. The relevant matters are still under further investigation by the public security authorities. (E-Pharma Manager)

Part 3 Pharmaceutical News

Another COVID-19 Vaccine Approved for Emergency Use in China

Recombinant Novel Coronavirus Vaccine (CHO Cell), jointly developed by the Institute of Microbiology, Chinese Academy of Sciences and Anhui Zhifei Longcom Biopharmaceutical Co., Ltd., has recently been approved for emergency use following recommendations from the National Health Commission and evaluation by the National Medical Products Administration. It is understood that recombinant vaccines are produced by expressing and purifying pathogen antigen proteins in engineered cells through genetic engineering techniques, and then formulating them into vaccines. Unlike adenovirus vector vaccines and inactivated vaccines, this is a new technological approach for developing COVID-19 vaccines. (Xinhua News Agency)

MSD’s Keytruda Rejected by UK’s NICE for Treating Urothelial Carcinoma

On the 18th, the UK National Institute for Health and Care Excellence (NICE) issued its second final evaluation document, rejecting Merck’s Keytruda for the treatment of advanced bladder cancer. The evaluation document indicated that Merck could collect further efficacy evidence for Keytruda under this indication, which would then be reviewed by NICE as part of its final decision. (Sina Pharmaceutical News)

AstraZeneca’s CLL Drug Calquence Approved by UK’s NICE

Recently, the UK’s National Institute for Health and Care Excellence (NICE) decided to recommend AstraZeneca’s BTK inhibitor Calquence (acalabrutinib) for inclusion in the UK National Health Service (NHS) for the treatment of certain adults with chronic lymphocytic leukemia (CLL). As a result, the drug has become the first targeted oral therapy for CLL patients in the UK who are unable to undergo first-line chemotherapy. (Sina Medical News)

CStone Pharmaceuticals’ “Avapritinib Tablets” Set for Imminent Market Approval

Recently, the official website of the National Medical Products Administration (NMPA) showed that the marketing application for CStone Pharmaceuticals’ precision targeted drug avapritinib tablets is currently “under review,” with approval expected in the near future. The two indications pending approval are: ① treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST) harboring platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutations (including the PDGFRA D842V mutation); and ② treatment of adult patients with unresectable or metastatic GIST in the fourth-line setting. (PharmaCube)

Zai Lab’s “Repotrectinib Tablets” Are Set for Imminent Approval and Market Launch

According to the official website of the National Medical Products Administration (NMPA), the marketing application for Zai Lab’s repotrectinib tablets (Acceptance Number: JXHS2000121) is currently in the “under review” stage and is expected to receive NMPA approval for market launch in the near future. The drug is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumors (GIST) who have previously received treatment with three or more kinase inhibitors, including imatinib. (PharmaCube)

Qilu’s $35 Million ADC Acquisition Approved for Clinical Trials

On the 19th, the CDE website showed that Qilu’s Vicinium (oportuzumab monatox, VB4-845) had been automatically approved for clinical trials, intended for the treatment of non-muscle-invasive bladder cancer. On July 31, 2020, Qilu and Sesen Bio entered into an exclusive licensing agreement, granting Qilu the exclusive rights to develop and commercialize Vicinium in Greater China (Mainland China, Hong Kong, Macau, and Taiwan). The drug is being developed for the treatment of Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer as well as other types of cancer. The total value of this collaboration was $35 million. (PharmaCube)

First FDA-Approved Therapy for Pericarditis! IL-1 Inhibitor Poised to Transform Treatment Paradigm

Kiniksa Pharmaceuticals Announces FDA Approval of Arcalyst (rilonacept), an IL-1 Inhibitor Developed by the Company, for the Treatment of Patients Aged 12 Years and Older with Recurrent Pericarditis and to Reduce the Risk of Recurrence. The press release noted that this is the first FDA-approved therapy for recurrent pericarditis. (WuXi AppTec)

Haili Bio's COVID-19 Antigen Test Kit Obtains CE Certification

Haili Bio announced that, in addition to its wholly-owned subsidiary Jemen Bio’s products obtaining EU CE certification, similar products from companies in other countries (including China) are also available on the market, thereby exposing the company to competitive risks from similar or other diagnostic products. The product in question is the SARS-CoV-2 Antigen Test Kit (Colloidal Gold Method) [SARS-CoV-2 Antigen Test Kit (Colloidal Gold)], with a validity period from March 17, 2021, to March 16, 2022. (Haili Bio Announcement)

Low Doses Led to Tumor Shrinkage in 80% of Patients: Preliminary Clinical Results of TCR Therapy for Solid Tumors Are Promising

Immatics Announces Early Anti-Cancer Activity of Its TCR Cell Therapy in Dose-Escalation Clinical TrialRecently, Immatics announced that its developed TCR cell therapy demonstrated anti-cancer activity in the early stages of a dose-escalation clinical trial. Among the 10 patients treated, 8 experienced tumor shrinkage, and 1 achieved partial response. (WuXi AppTec)

Eli Lilly Antibody Bamlanivimab Distribution Halted in Three U.S. States

According to Endpoints News, on the 17th, Janet Woodcock, Acting Commissioner of the U.S. FDA, announced to physicians attending an American Medical Association webinar that the U.S. government would no longer distribute Eli Lilly’s bamlanivimab to California, Arizona, and Nevada, as virus variants insensitive to this monoclonal antibody had begun to prevail. (Sina Pharmaceutical News)

Semaglutide Combination Therapy for NASH: Novo Nordisk/Gilead Expand Collaboration

Gilead Sciences and Novo Nordisk Jointly Announce Expansion of Clinical Collaboration for Non-Alcoholic SteatohepatitisGilead Sciences and Novo Nordisk have jointly announced an expansion of their clinical collaboration targeting non-alcoholic steatohepatitis (NASH). Under the agreement, the two companies will initiate a Phase 2b clinical trial evaluating semaglutide, Novo Nordisk’s GLP-1 receptor agonist, either as monotherapy or in combination with a fixed-dose combination regimen comprising cilofexor, Gilead Sciences’ investigational farnesoid X receptor (FXR) agonist, and firsocostat, an acetyl-CoA carboxylase (ACC) inhibitor, for the treatment of NASH patients with compensated cirrhosis. (WuXi AppTec)

$2.2 Billion to Fuel New Strategies Targeting “Undruggable” Targets: Takeda Strikes Deal

Anima Biotech Announces Strategic Collaboration with Takeda to Discover and Develop Small-Molecule Drugs Targeting mRNA Translation for the Treatment of Neurological Disorders with Specific Genetic ProfilesTraditional small-molecule drugs face challenges in targeting “undruggable” targets because these protein targets lack binding “pockets” for small molecules. In contrast, Anima Biotech’s strategy does not directly target the protein itself, but rather the translation process of the mRNA encoding the target protein. (WuXi AppTec)

The Lancet: 6.9% of Wuhan Population Tested Positive for COVID-19 Antibodies, with 82% Being Asymptomatic

The latest issue of The Lancet has been released, featuring a landmark publication of Wuhan’s first long-term serological study on SARS-CoV-2 antibodies. Data from the study, which began after Wuhan’s “lockdown lift” in April 2020 and continued with follow-ups through December 2020, indicate that 6.9% of Wuhan’s population possessed SARS-CoV-2 antibodies. Among those who tested antibody-positive, 40% had detectable neutralizing antibodies that remained stable for nine months, and 82% had experienced asymptomatic infections. These milestone findings suggest the durable protective effect of neutralizing antibodies, while also indicating that the majority of the population remained uninfected, necessitating large-scale vaccination to achieve herd immunity. (New Perspectives in Medicine)