《科创板日报》专注新兴产业与资本生态，深度覆盖新一代信息技术、半导体、AI、生物医药、新能源、新材料、元宇宙、新消费、产业基金、创投机构等行业，联合百家一线投资机构、创新创业型公司、龙头企业，形成专业的服务体系。①The State Administration for Drug Regulation solicits opinions on new regulations for export of drugs; the National Medical Insurance Bureau announced lists of 440 drugs that passed the preliminary review; ②Beigene's revenue in the first half of the year was nearly $12 billion, and sales of Baiyuzhe increased by 122% year-on-year; ③Novo Nordisk's Semaglutide and Eli Lilly's Tirzepatide both sold nearly $13 billion and $6.7 billion respectively in the first half of the year; ④Meilweiye and Xinmai Medical's domestic RDNs were approved for listing.
August 11th, Ke Chuang Ban Daily (Reporter Xu Hong, Intern Writer Xu Ye): This week (August 5th to August 11th), important dynamics in the medical industry include:
The State Administration for Drug Regulation solicits opinions on new regulations for export of drugs; the National Medical Insurance Bureau announced lists of 440 drugs that passed the preliminary review; Beigene's revenue in the first half of the year was nearly $12 billion, and sales of Baiyuzhe increased by 122% year-on-year; Novo Nordisk's Semaglutide sold nearly $13 billion in the first half of the year, and Eli Lilly's Tirzepatide sold $6.7 billion, the first adrenaline nasal spray was launched in the United States; Meilweiye and Xinmai Medical's domestic RDNs were listed; Kechuang Group submitted an application for IPO to the Hong Kong Stock Exchange; Bloomage Biotechnology Corporation Limited participated in this investment, and Ruijiming completed its Series A financing.
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>>>Policy
The State Administration for Drug Regulation solicits opinions on new regulations for exporting drugs to ensure the quality of domestically produced exported drugs
On August 6th, the State Administration for Drug Regulation issued the "Regulations on the Supervision and Administration of the Production of Exported Drugs (Draft for Soliciting Opinions)" and will solicit public opinions on the existing content before September 10th.
The "Draft for Solicitation of Opinions" stipulates that drug manufacturers bear the main responsibility for the quality and safety of exported drugs, and must strictly ensure that the entire process of drug production complies with relevant Chinese and importing countries (regions) laws, regulations, quality standards. Previously, there was no special regulation for exported drugs in China, and the quality and safety of production were mostly supervised by overseas regulatory authorities. However, according to statistics from the FDA official website, in the past three months, the FDA has issued 11 warning letters to Chinese pharmaceutical companies, far exceeding the data in previous years.
The National Medical Insurance Bureau announced lists of 440 drugs that passed the preliminary review
On August 7th, the National Medical Insurance Bureau released the "Announcement on Publicizing the List of Drugs and Related Information That Passed the Preliminary Review of the Adjustment of the National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug List in 2024", and publicly announced the preliminary review of the list of drugs that passed the preliminary review, with a total of 440 drugs. This public notice is from August 7th to August 13th. The National Medical Insurance Bureau will determine the final review list according to feedback.
According to statistics from Ke Chuang Ban Daily, in the first half of 2024, more than 40 new drugs are expected to be approved for the first time in China, and many of these drugs have entered the preliminary review list, including Zailab's Ripretinib capsule, Novartis' ipatropium chloride capsules, and Dizhe Pharmaceutical's recently approved Golvatinib capsule.
The Beijing Municipal Drug Administration has announced the list of the first batch of pilot institutions for optimizing and innovating clinical trial review and approval of innovative drugs
The State Administration for Drug Regulation recently issued the "Work Plan for Pilot Projects for Optimizing Innovative Drug Clinical Trial Review and Approval", proposed to optimize the mechanism for reviewing and approving clinical trials of innovative drugs, shorten the clinical trial start time to within 30 working days, carry out pilot projects in provinces that meet the conditions, and the project scope is 1 type of innovative drugs (excluding cell and gene therapy products, vaccine products, etc.) clinical trial applications, pilot institutions are generally national medical centers or national clinical medical research centers in pilot areas. Currently, Beijing and Shanghai have been approved as pilot areas.
On August 8th, the Beijing Municipal Drug Administration determined that 11 clinical trial institutions such as Peking Union Medical College Hospital and Cancer Hospital of Chinese Academy of Medical Sciences were the first batch of pilot institutions for optimizing and innovating clinical trial review and approval of innovative drugs.
>>>Major Events & Companies
Beigene released its H1 2024 performance report, and the sales revenue of Baoyueze increased by 122% year-on-year.
On August 7th, Beigene released its Q2 2024 earnings report for the US stock market and the semi-annual performance report for the A-share market. The A-share report shows that the company's revenue in the first half of the year was 11.996 billion yuan, a year-on-year increase of 65.4%. The US stock market report shows that Beigene's GAAP operating loss in the second quarter decreased by 66% compared with the same period last year, and the loss amount continued to narrow.
In the first half of the year, the company's main product, anticancer drug Baoyueze (Zebutinib capsules), had a sales revenue of US$1.126 billion, a year-on-year increase of 122%, of which revenue from the European and American markets accounted for more than 80%. Zebutinib has been approved in more than 70 markets worldwide and is the only BTK inhibitor that has achieved superior efficacy results compared to "star drug" Ibrutinib in head-to-head trials.
Novo Nordisk's semaglutide sales in H1 of this year approached $13 billion.
On August 7th, Novo Nordisk announced its first-half 2024 performance, with total revenue of DKK 133.409 billion (USD 19.366 billion), a year-on-year increase of 25%.
Among them, the sales of GLP-1 diabetes drugs reached DKK 72.017 billion (USD 10.454 billion), a year-on-year increase of 32%, accounting for 56% of the global GLP-1 market share. The sales of obesity drugs were DKK 24.939 billion (USD 3.62 billion), a year-on-year increase of 37%, and accounted for 91% of the global market share. Novo Nordisk is also a major leader in the Chinese GLP-1 market, with an estimated 79% market share.
Specifically, Ozempic, the sugar-lowering semaglutide injection, has maintained a high growth rate of 36% for many years, with half-year revenue of DKK 56.685 billion (USD 8.228 billion); Rybelsus, the semaglutide tablet for oral administration, generated revenue of DKK 10.931 billion (USD 1.587 billion), a year-on-year increase of 32%; Wegovy, the semaglutide injection for weight loss, generated revenue of DKK 21.036 billion (USD 3.054 billion), a year-on-year increase of 74%. The total revenue of the three products in the first half of the year was DKK 88.652 billion, or USD 12.869 billion, and is expected to exceed USD 25 billion for the full year.
In the Chinese market, the sales of Ozempic (semaglutide injection for sugar reduction) have reached DKK 2.935 billion (USD 0.426 billion, +38%). In January of this year, Rybelsus (semaglutide tablet for oral consumption) was also approved for marketing in China, making it the first GLP-1 receptor agonist approved for oral administration domestically. In less than half a year, Rybelsus has sold DKK 0.108 billion (USD 0.016 billion, +67%) in China.
Eli Lilly's tirzepatide sold $6.7 billion in H1.
On August 8th, Lilly released its Q2 report. The revenue in Q2 was USD 11.3 billion, a year-on-year increase of 36%, exceeding market expectations of USD 9.98 billion. Combining the first quarter, Lilly's revenue in the first half of the year was USD 20.071 billion, a year-on-year increase of 31%. Lilly announced that its full-year revenue is expected to be adjusted from USD 42.4-43.6 billion to USD 45.4-46.6 billion.
Among them, the sales of 'the strongest weight loss drug' tirzepatide topped the list, with sales of DKK 4.897 billion (USD 0.711 billion) for the sugar-lowering version Mounjaro and DKK 1.761 billion (USD 0.256 billion) for the weight-loss version Zepound, totaling USD 6.658 billion. The revenue of dulaglutide Trulicity for sugar-reducing was USD 2.702 billion, a year-on-year decrease of 29%. The revenue of the CDK4/6 inhibitor Verzenio was USD 2.382 billion, a year-on-year increase of 42%.
In addition, Lilly announced in its report that the GIP/GLP-1 receptor dual agonist, Tirzepatide, which is used to improve sleep apnea in obese patients with moderate to severe obstructive sleep apnea (OSA), has submitted a marketing application to regulatory agencies in Europe and the United States. FDA approval may be obtained as early as the end of this year.
Madrigal announced its Q2 2024 financial report and NASH new drug sales far exceeded expectations.
On August 7, Madrigal Pharmaceuticals announced its Q2 earnings. The company's flagship product, and the first and only FDA-approved non-alcoholic fatty liver disease (NASH) treatment, Rezdiffra, achieved sales of $14.6 million in its first full quarter on the market, almost triple the analyst's expectations.
Rezdiffra is currently under evaluation by the European Medicines Agency's (EMA) Committee for Human Medicinal Products (CHMP). Madrigal plans to commercialize Rezdiffra independently in mid-2025 and does not seek local partners. The company's spending is currently higher than expected and will only increase as it enters the European market next year. After the report was released, Madrigal's stock price fell 13% that day.
Amgen released its Q2 2024 financial report, with growth exceeding expectations.
Amgen released its Q2 2024 financial report, with sales exceeding Wall Street's expectations, reaching $8.4 billion, surpassing the average analyst's forecast of $8.34 billion.
Sales growth was mainly driven by old drugs like Prolia for osteoporosis and Repatha for cholesterol reduction, including the newly launched IMDELLTRA for tumors in May this year. The company has 12 products that achieved at least double-digit sales growth.
Amgen's growth in the second quarter has laid the foundation for its expansion into other areas. The company stated that it will also raise its full-year capital expenditure expectations to increase investment in the weight-loss drug MariTide. Although the frequency of use for MariTide is low compared to the best-selling drugs of Eli Lilly and Co. and Novo Nordisk A/S, Amgen is bullish on the future development of the weight-loss drug market. Product structure, the operating income of 10-30 billion yuan products was 401/1288/60 million yuan respectively.
Merck & Co. has reached the final agreement with TRC201 of Tongrun Biopharm for the CN201 acquisition
On August 9, Merck & Co. announced that it has reached the final agreement with Tongrun Biopharm for the acquisition of the global rights of CN201, a new investigational clinical-stage bispecific antibody for the treatment of B-cell-related diseases. Merck & Co. will pay a cash upfront payment of $0.7 billion and a maximum of $0.6 billion in milestone payments to obtain the global rights of CN201.
CN201 is a new type of bispecific antibody that targets CD3/CD19, mediates the activation of T cells, and clears B tumor cells. It is currently in phase 1 and 1b/2 clinical trials for the treatment of relapsed or refractory non-Hodgkin's lymphoma (NHL) and relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). Initial clinical data have shown good prospects for CN201 in the treatment of patients with relapsed or refractory B-cell hematological malignancies.
JahwaBio licensed CD3/CD20 bispecific antibody GB261 to TRC 2004, and the "NewCo model" helps to go overseas.
On August 5th, JahwaBio announced that it has granted the global rights outside Greater China of CD3/CD20 bispecific antibody GB261 to TRC 2004. TRC 2004 will pay objective equity, tens of millions of dollars in advance, $0.443 billion in milestone payments, and a single to double-digit ratio of sales sharing.
This business model, called the "NewCo model," involves working with overseas capital to set up a new company. While granting product rights, it also takes a certain degree of dominance in the new company. Hengrui Pharmaceuticals, with its GLP-1 product portfolio, has joined forces with Bain Capital, Atlas and other companies to go overseas, and Kangenya Biosciences has teamed up with OrbiMed to go overseas. The NewCo model is gradually becoming an important way for domestic innovative drugs to go overseas.
Sangamo Therapeutics has reached a licensing agreement with Genentech to develop gene therapy for Alzheimer's disease.
On August 7th, Sangamo Therapeutics announced that it has reached a licensing agreement with Genentech, a subsidiary of Roche, to develop intravenous gene therapy for the treatment of neurodegenerative diseases, including Alzheimer's disease.
Under the agreement, Sangamo will receive an upfront payment of $50 million and is eligible to receive up to $1.9 billion in development and commercial milestone payments. Genentech will be responsible for all clinical development, regulatory, manufacturing, and commercial activities, and will have rights to develop epigenetic inhibitors based on zinc finger proteins and to use Sangamo's unique adeno-associated virus (AAV) coat STAC-BBB.
In recent years, there have been continuous breakthroughs in new drugs for Alzheimer's disease, including Leqembi developed by Jointown Pharmaceutical Group and Bojian, and Kisunla developed by Eli Lilly and Co. The advantage of Sangamo's gene therapy lies in the high expression level of STAC-BBB-delivered transgenes in brain tissue, and it is applicable to a wide range of central nervous system tissues with individual variability.
>>>Products
Shanghai Antaike Medical Technology Co., Ltd.'s balloon cryoablation catheter listed for sale, used in conjunction with cryoablation instrument.
On August 6th, the balloon cryoablation catheter independently developed by Shanghai Antaike Medical Technology Co., Ltd. was approved for listing by the National Medical Products Administration.
The product consists of a balloon cryoablation catheter and a hand-operated retractor, which is used in conjunction with the company’s cryoablation instrument that has been approved for sale to treat adult patients with drug-resistant, recurrent, and symptomatic paroxysmal atrial fibrillation. Compared with similar products at home and abroad, the technology of this product is innovative, which can reduce the damage to adjacent tissues and the risk of other clinical operations while ensuring the therapeutic effect of cryoablation. Further serving the diverse clinical needs of "simple ablation" for atrial fibrillation in China.
Shanghai MeiLiWeiYe Medical Technology Co., Ltd.'s Netrod Star Belt mesh renal artery radiofrequency ablation system and Suzhou XinMai Medical Technology Co., Ltd.'s renal nerve marker/selective ablation system for the treatment of refractory hypertension and drug-resistant hypertension patients were both approved for listing on the same day.
On August 6th, Shanghai MeiLiWeiYe Medical Technology Co., Ltd.'s Netrod Star Belt mesh renal artery radiofrequency ablation system, and Suzhou XinMai Medical Technology Co., Ltd.'s renal nerve marker/selective ablation system, were approved for listing by the National Medical Products Administration on the same day. Both products are suitable for the auxiliary treatment of patients with refractory hypertension and drug-resistant hypertension.
The first adrenaline nasal spray for emergency allergy treatment has been approved for sale in the United States.
On August 10, the Neffy (adrenaline nasal spray) developed by ARS Pharmaceuticals was approved for sale in the United States by the U.S. FDA for the emergency treatment of type I allergic reactions in adults and children weighing at least 30 kg, including potentially life-threatening anaphylactic shock. This approval represents the first significant innovation in the delivery of adrenaline in 35 years. Previously, adrenaline could only enter the body through injection, and adrenaline is also the only treatment for anaphylactic shock that can save lives. The nasal spray will greatly improve the convenience of medication and the success rate of emergency treatment.
Roche children's influenza drug Marburysorvay suspension officially launched in China.
On August 8th, Roche Pharmaceuticals China announced in Shanghai that its innovative anti-influenza drug Sovaldyollision suspension (generic name: Marburysorvay suspension) was officially launched in China.
This drug is a strawberry-flavored dry mixed suspension designed specifically for children. The dry mixed suspension is a powder or granule made of insoluble drugs and appropriate excipients, which can be dispersed into a suspension for oral administration by adding water. Parents can accurately administer the drug based on the child's weight, and only one dose is required for the whole course of treatment, overcoming the difficulties faced by parents in dosing and determining the dosage for children for a long time.
Boan Biotechnology's GLP-1 Clinical Trial Approved in the US
On August 5th, Boan Biotechnology announced that its self-developed Dulaglutide Injection (BA5101) has obtained FDA approval to conduct clinical trials in the United States.
Dulaglutide is a long-acting GLP-1 receptor agonist injected once a week, intended for blood glucose control in type 2 diabetes patients. The drug can improve the function of pancreatic β cells, stabilize and lower blood glucose and glycated hemoglobin levels, and reduce the risk of weight, blood lipids, renal disease and long-term cardiovascular diseases.
Dulaglutide is a biosimilar drug of Lilly's Trulicity, which has been approved for marketing in several countries and regions including China. Currently, BA5101 has entered the review and approval stage of listing application in China.
IPO
Dakewe Biotech's Listing on the Shenzhen Stock Exchange IPO has been Terminated
On August 5th, Dakewe Biotechnology Co., Ltd. and the lead underwriter CITIC Guofu Securities Co., Ltd., actively withdrew the registration application document of the Shenzhen Stock Exchange, and the company's IPO listing was terminated. In September 2021, Dakewe Biotechnology's GEM IPO was accepted, and in July 2022, Dakewe Biotechnology passed the GEM IPO review and submitted the registration in the same year. However, after a year and a half, the IPO was not further progressed, and the company eventually chose to withdraw from the market.
Dakewe Biotechnology is a professional provider focusing on life science research services and pathological diagnosis. Its services include bio-pharmaceutical companies, national top three hospitals, universities and research institutes, etc. At present, the company is facing the risk of fluctuation in performance due to economic downturn and has always maintained a high level of R&D investment.
CStone Pharmaceuticals Group files for Hong Kong IPO
Recently, oncology innovative therapy biopharmaceutical company CStone Pharmaceuticals Group submitted a prospectus to the Hong Kong Stock Exchange, planning to list on the Main Board IPO, with CITIC Securities as its sole sponsor.
CStone Pharmaceuticals Group is committed to researching how to treat 'cold tumors' resistant to anti-cancer drugs from the perspective of the tumor microenvironment. Currently, the company has six innovative pipelines, four of which are in clinical stage and two are in preclinical stage, and there is no commercialized product yet. The company's investment partners are strong, and Lilly Asia Fund has invested in CStone Pharmaceuticals through LAV USD and has participated in A+ and B rounds of financing. In addition, Shanghai Lile, Hillhouse Capital, Greater Bay Area Fund, and Huiding Investment are also the company's investors.
Baozhong Baoda's Listing on the SSE IPO has been Terminated
Recently, the Shanghai Stock Exchange official website showed that Jiangsu Baozhong Baoda Pharmaceutical Co., Ltd. and the sponsor actively withdrew the IPO application, and the listing on the main board was terminated.
Baozhong Baoda is mainly committed to providing customized production services for global crop protection, new materials, and pharmaceutical companies, and is engaged in the production and sales of some veterinary drugs and self-owned pharmaceutical product series. The company has established three core technology platforms of chemical synthesis, process optimization, and engineering technology, which can provide customers with intermediate or API customized production services in the fields of crop protection, new materials, and medicine.
Primary Market
Rigiming completes Series A Financing，Hua Xing Bio-medicine increases investment in the field of regenerative aesthetics
Recently, Marine biological regeneration medical beauty raw material company Rugiming (Shandong) Biotechnology Co., Ltd. completed a series A financing, led by Hohxing Capital Venture Capital (Huzhou) Co., Ltd., with Shanghai Shuiyang Management Consulting Co., Ltd. as the follow-up investment to promote its independent R&D of nucleic acid series raw materials commercialization production and international market process. The amount of financing has not been disclosed.
In November last year, Huiyu Investment and Bloomage Biotechnology, together with Huzhou Industrial Investment, officially signed an agreement to establish an industrial investment fund focused on life science and healthy living, with a total size of 1 billion RMB. This financing is Huiyu Investment's first external investment after the medical health industry fund, and has significant strategic significance. For Bloomage Biotechnology, this investment can fully leverage the industrial synergy effect of Bloomage Biotechnology and Regeneron, and also means another important layout in the field of regenerative medicine and beauty for Bloomage Biotechnology.
Zhengxu Biosciences has completed a round of A+ financing of more than 100 million RMB, accelerating the promotion of the hemoglobin disease pipeline.
On August 8th, Zhengxu Biosciences, which was incubated by ShanghaiTech University, announced the completion of a round of A+ financing of more than 100 million RMB. This round of financing was led by Shanghai Guotou Futeng Capital, with follow-up investments from Lianxin Capital, Boyu Capital, Lilly Asia Ventures, Matrix Partners China, and Sequoia China. The funds will be used to accelerate the clinical research and commercialization of CS-101.
Zhengxu Biosciences is a clinical-stage biotechnology company focused on innovative gene editing technology, with multiple pipelines for genetic diseases, metabolic diseases, and cardiovascular diseases. CS-101 is the first pipeline in its layout, which is an innovative gene editing therapy developed for hemoglobin diseases and has received clinical trial approval (IND) from the National Medical Products Administration in April this year.