Yiling Pharma Surpasses Tongrentang in Market Cap; Four Chinese Drugmakers Enter World Top 500; Hengrui Sees Four Executives Depart; Former Chairman of *ST Jiyao Arrested

The Fall of a Billion-Dollar TCM Injection: Renowned Pharmaceutical Company Fined! Four Leading Companies Enter Fortune Global 500, Top 3 TCM Stocks See Changes in Market Value

Source: MiNei Net

Highlights: This week, new epidemic prevention policies were released successively, triggering a buying frenzy for antigen detection products and commonly used drugs for home treatment, influenced by positive news.Yiling PharmaMarket Value Hits a New High. The National Medical Insurance Negotiation Officially Announced a Delay, with the Fate of 280 Exclusive Products Drawing Significant Attention. Formerly Popular Traditional Chinese Medicine Injections Have Ceased Trading in Yunnan; Major Price Cuts for Several Best-Selling Drugs from Huiyu, Lunan Better, and Lepu. Hengrui Pharma and Hansoh Each Receive Approval for a First Generic Drug; Akeso’s AK112 Sets a New Record for Bispecific Antibody Licensing Deals. The Fortune Global 500 List is Released, Featuring Four Leading Domestic Companies… Key Events in the Pharmaceutical Industry This Week – A Must-See!

　　Four companiesChina PharmaLeading Enterprises Ranked in Fortune Global 500

On December 9, the Hurun Global 500 was released. China ranked second in terms of the number of companies, with 35 companies listed. The healthcare industry ranked third, with a total of 52 enterprises on the list. Specifically, Johnson & Johnson ranked eighth on the overall list with a value of 3.219 trillion yuan, making it the most valuable company in the healthcare industry; among Chinese enterprises, Mindray ranked 236th.Hengrui Pharma、WuXi AppTec(Maintain Rights)、Aier EyeRanked after 400th. Notably, WuXi Biologics,Chongqing Zhifei Biological Products Co.,Ltd.This year, it failed to make the list. The rankings in 2021 were 204th and 381st respectively. (Hurun Report Official Website)

　　China's National Healthcare Security Administration Officially Announces Postponement, 280 Exclusive Products Prepare for Negotiations

On December 6, the official website of the National Healthcare Security Administration announced that the on-site negotiations for the 2022 National Healthcare Security Drug Catalogue have been postponed. The validity period of negotiated drugs in the catalogue, whose agreements are set to expire at the end of the year, will be automatically extended until the official implementation of the new version of the catalogue. In September this year, a list of drugs that passed the initial formal review was published, involving 198 drugs outside the catalogue, of which 157 are exclusive products, with Hengrui Pharma preparing six major products; and 145 drugs within the catalogue, of which 123 are exclusive products, with 13 products under Novartis set to renew or add new indications. (Organized by Menet)

Viewpoint:

Overall, both exclusive and non-exclusive products face pricing pressures, but the reference price for exclusive products is based on their own, resulting in relatively moderate pressure to cut prices. This benefits innovative pharmaceutical companies, making the enhancement of innovation capabilities possibly the best choice for pharmaceutical enterprises. On the other hand, non-exclusive products will be subject to competitive bidding, the intensity of which may rival that of centralized procurement.

　　The Second Batch of Rare Disease Catalogue is Coming

On December 9, the official website of the National Health Commission (NHC) released a response to Proposal No. 5699 from the fifth session of the 13th National People's Congress, mentioning that the NHC will continue to advance work related to rare diseases. First, following the procedures for formulating the rare disease directory, the second batch of the rare disease directory will be adjusted and updated in a timely manner; relying on the Expert Committee on Diagnosis, Treatment, and Security of Rare Diseases and the Collaborative Network for Rare Disease Diagnosis and Treatment, the guidelines for the rare disease directory will be updated, training on rare disease diagnosis and treatment will be conducted, and the level of rare disease diagnosis and treatment in China will be improved. Second, actively cooperating with relevant departments to promote the construction of industry associations, increase hospitals' attention to rare diseases, and ensure proper guidance and supervision of rare disease-related work. (National Health Commission Official Website)

Highlight:

In May 2018, the "First List of Rare Diseases" was announced, covering 121 rare diseases including 21-hydroxylase deficiency, albinism, hemophilia, and more. Over four years since the issuance of the List, China’s rare disease initiatives have accelerated, with multiple rare disease drugs being included in the annual adjustment of the medical insurance catalog. In 2022, the preliminary review list for adjustments to the medical insurance catalog included another 19 rare disease drugs not yet listed, with results eagerly awaited.

　　Seven Non-Basic Drugs Halt Trading, Involving Traditional Chinese Medicine Injections

On December 5, the Yunnan Provincial Government Procurement and Transfer Center announced that due to force majeure reasons, the production enterprises were temporarily unable to supply products for online trading. Based on the applications from relevant enterprises and the certification documents issued by the food and drug regulatory departments where the production enterprises are located, seven non-essential drugs have ceased trading qualifications. These include Olopatadine Hydrochloride Tablets from Sichuan Ziren Pharmaceutical, Metamizole Sodium Injection from Xinxiang Changle Pharmaceutical, Alogliptin Benzoate Tablets from Sinopharm Group Guorui Pharmaceutical, Levornidazole Tablets from Hunan Warner Pharmaceutical, Carthamus Tinctorius Injection from Shanxi Huawei Pharmaceutical, Liangjie Cold Mixture (exclusive product) and Piracetam Capsules from Shaanxi Bailu Pharmaceutical. (Official website of Yunnan Province Medicine Centralized Procurement Platform)

Data says:

Safflower Injection was once a major traditional Chinese medicine injection product, used to treat occlusive cerebrovascular diseases, coronary heart disease, and vasculitis. Data from MiNe Network shows that the sales of this product in China's public medical institutions exceeded 1 billion yuan each year from 2013 to 2016. However, after 2017, sales rapidly declined, with only 40 million yuan in sales in the first half of 2022. Thus, a once "miracle drug" has fallen.

　　Huiyu, Lunan Better, Lepu... Best-Selling Drugs See Major Price Cuts

On December 6, the Shaanxi Provincial Public Resources Trading Center issued a notice. According to relevant regulations and routine adjustment requirements, the listing prices of 15 drugs have been reduced. SichuanHuiyu PharmaInvolved four drugs (counted by product name + specification, the same below), among which the price reductions for both specifications of Irinotecan Hydrochloride Injection exceeded 27%; Lunan Better Pharmaceutical involved two drugs, among which the price reduction for Isosorbide Mononitrate Dispersible Tablets (20mg) exceeded 45%; the price reduction for Betahistine Hydrochloride Tablets (8mg) from Lepu Hengjiuyuan Pharmaceutical was also over 20%. (Official website of Shaanxi Provincial Public Resources Trading Center)

　　Another Typical Case Exposed

The medical insurance fund isCommon PeopleThe "lifeline money" is crucial for safeguarding the security of medical insurance funds and enhancing deterrence. On December 7, the Shaanxi Provincial Medical Insurance Bureau announced the second batch of typical cases for 2022. These include the case of Zhang Mouying from Jintai District, Baoji City, who allowed others to use her medical insurance credentials under a false name; the case of Zichang Hexie Hospital defrauding medical insurance funds; and the case of Zhouzhi Fengrong Hospital’s improper use of medical insurance funds. The three cases involved a total amount of nearly 85,000 yuan in medical insurance funds. (Shaanxi Provincial Medical Insurance Bureau)

　　39 Companies Compete for a 600 Billion Market

As the epidemic prevention and control policies are gradually optimized, antigen testing is expected to become an important detection method. As of December 9, 39 companies in China have been approved for the registration certificates for COVID-19 antigen testing.Wantai Bio, Fosun Diagnostics, Zhuhai Livzon Reagent, BGI Health, and other companies. Some securities analysts believe that if China officially lifts restrictions on self-testing antigen kits, and considering the stockpiling habits of Chinese residents and enterprises, the annual demand for COVID-19 antigen testing products will reach 600 billion yuan. On December 8, the National Medical Products Administration (NMPA) announced that the validity period of the registration certificates for already approved SARS-CoV-2 antigen test kits would be extended by six months from their original expiration dates. (21st Century Business Herald)

　　Yiling Pharmaceutical Breaks into the TOP3 of Traditional Chinese Medicine Stock Market Value

On December 7, the new ten measures for further optimizing epidemic prevention and control were released, and on December 8, the Joint Prevention and Control Mechanism of the State Council issued the "Home Treatment Guidelines for COVID-19 Patients," accompanied by the "Reference List of Commonly Used Drugs for Home Treatment of COVID-19 Patients." Lianhua Qingwen Granules/Capsules, Ibuprofen, and Aspirin were all included in the list, leading to a surge in market demand for cold-related drugs. Lianhua Qingwen is an exclusive product of Yiling Pharmaceutical, which has reportedly faced multiple "out-of-stock" situations this year. The company stated that it is taking various measures to expand production, fully ensuring market supply and stabilizing supply prices. Due to favorable factors, the stock price of Yiling Pharmaceutical has increased by over 160% this year, with the company's total market value exceeding 85 billion yuan, ranking it among the top three in the traditional Chinese medicine stock market. (Investment Express)

Top 5 TCM Companies by Market Value in China's A-Share Market

Statistics as of the afternoon closing on December 9

　　Over $5 Billion! Akeso Biopharma Sets New Record for Overseas Expansion

On December 6, Akeso Biopharma announced its plan to list on the STAR Market. On the same day, it further issued an announcement stating that it had reached a collaboration with the UK-based pharmaceutical company Summit Therapeutics. The agreement grants Summit exclusive rights for the development and commercialization of Akeso’s investigational PD-1/VEGF bispecific antibody AK112 in the US, Canada, Europe, and Japan. Akeso Biopharma will receive an upfront payment of $500 million, with additional payments tied to product development, regulatory, and commercial milestones. The total transaction value could reach $5 billion, equivalent to nearly 35 billion RMB, setting a new record for the highest overseas deal amount for a bispecific antibody in China. An insider from Akeso Biopharma stated that AK112 has already entered Phase III clinical trials in China, offering higher certainty compared to some products that were licensed out during Phase II or Phase I trials, making the higher upfront payment reasonable. (Jian Shi Ju)

　　Hausen Secures Major Injection as the First Domestic Generic in China

News from the NMPA official website on December 8th, Hansoh's Icatibant Acetate Injection has been approved for marketing in China, indicated for acute attacks of hereditary angioedema. This is the first approved generic version of Icatibant in China. The original injection was developed by Takeda, with global sales reaching 26.7 billion yen (approximately 200 million US dollars at the current exchange rate) in 2021. The original Icatibant Acetate Injection was approved to enter the Chinese market in April 2021 and has been included in the medical insurance negotiation directory. (Compiled by MIRNET)

Source: MiNei Network New Database

　　Kelon PharmaClinical Data of TROP2-ADC Drug Disclosed

Central U.S. time on December 6, the 45th San Antonio Breast Cancer Symposium (SABCS) officially opened. The efficacy and safety data from the Phase II expansion study of Kolon Pharmaceuticals' holding subsidiary Kolon Biotech's TROP2-ADC (SKB264, MK-2870) for locally advanced or metastatic triple-negative breast cancer (TNBC) patients was accepted by the conference in poster form and presented and discussed at the conference site. In terms of efficacy, among 55 evaluable patients, the confirmed objective response rate (ORR) was 40%, and the disease control rate (DCR) was 80%. Based on preliminary clinical data, SKB264 is currently conducting multiple Phase II and III clinical trials as monotherapy or combination therapy for various tumor types. In 2022, SKB264 has made rapid progress in its development, with six clinical studies approved since January (five in China, one in the U.S.). (Securities Times)

　　Hengrui Pharma Sees Departure of Four Senior Executives This Year

On December 5, Hengrui Pharma announced that Zhang Xiaojing had applied to resign from her positions as Vice General Manager and Chief Medical Executive Officer (Oncology) due to personal reasons. On December 7, Antengene Corporation announced the appointment of Zhang Xiaojing as the company’s Chief Medical Officer (CMO). So far this year, four senior executives of Hengrui have resigned: In February, Zhang Yuehong resigned from the position of Vice General Manager; in April, Zou Jianguo resigned from the position of Vice General Manager due to personal reasons; in October, Tao Weikang applied to resign from the position of Vice General Manager due to personal reasons… Industry insiders believe that Hengrui's performance has been under pressure in recent years. To accelerate the company’s transformation and development, executive changes will be more conducive to stimulating team vitality and increasing momentum for transformation. (Company Announcement)

　　Yuandong BiologicsRe-certified as a High-tech Enterprise

On December 6, Yuandong Biotech announced that it had recently received the "High-tech Enterprise Certificate" jointly issued by the Sichuan Provincial Department of Science and Technology, the Sichuan Provincial Department of Finance, and the State Administration of Taxation of Sichuan Province. The certificate is valid for three years. According to relevant tax policies, the company can continue to enjoy national tax incentives for three consecutive years from the date of re-certification as a high-tech enterprise. (Company Announcement)

　　Well-known pharmaceutical company fined! Former chairman already arrested

December 9*ST Ji Medicine(Maintain Rights)Announcement revealed that the company received administrative penalties from the Jilin Securities Regulatory Bureau due to suspected illegal and non-compliant information disclosure. The Jilin Securities Regulatory Bureau intends to issue warnings and impose combined fines of 3.9 million yuan on the company and relevant responsible persons (Sun Jun, Xu Wei). Public information shows that Sun Jun began serving as the company's chairman in October 2017 and left the company in June 2022. *ST Ji Medicine previously announced in August this year that the former chairman Sun Jun and the former director and deputy general manager Wang Deheng had been approved for arrest on suspicion of duty-related crimes. (China Securities Journal)

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Editor: Chang Fuqiang