Two deals in a week: Chinese biotech's overseas journey continues.On July 9, Connexions announced that it had granted Belenos of the United States the exclusive rights to develop, manufacture, and commercialize two early-stage bispecific antibody products outside of Greater China for a total transaction value of $185 million.Notably, Connaught achieved a 30.01% stake in Belenos through its wholly-owned subsidiary, Yiqiao Hong Kong. Following this transaction, OrbiMed holds 50.26%, Connaught holds 30.01%, and the company's chairman has been nominated as one of Belenos’ four directors. Belenos, which partnered with Connaught in this deal, was established in June this year, reminiscent of Hengrui’s recent overseas collaboration model involving joint ventures with foreign capital.Unlike ConnaMed's previous successful multiple product out-licensing, on July 11, Yuyan Technology announced a collaboration with French pharmaceutical company Ipsen regarding the drug molecule FS001, marking the first time this Chinese biotech company has achieved a commercial closed loop.Yuyan Technology was incubated and established by Nest.Bio Capital at the end of 2021. The founder and chairman is Huang Chaolan. In addition to serving as the chairman of Yuyan Technology, Huang Chaolan is also the executive deputy director of the National Key Laboratory for Rare and Critical Diseases at Peking Union Medical College Hospital, a lifetime professor at the Chinese Academy of Medical Sciences and Peking Union Medical College, and a researcher at the Tsinghua-Peking Center for Life Sciences.Similarly, this week, there have been frequent personnel changes in multinational pharmaceutical companies.Pfizer and AbbVie Both Announce Changes in Chief Scientific Officers. Mikael Dolsten, Pfizer's Chief Scientific Officer and President of R&D, has left the company after serving for over 15 years. Dolsten joined Pfizer in 2009 following the acquisition of Wyeth, taking on the role of Global R&D President. Roopal Thakkar, AbbVie’s Senior Vice President of Global Therapeutics and Chief Medical Officer, will succeed Thomas J. Hudson, who is retiring, as AbbVie’s Executive Vice President of R&D and Chief Scientific Officer.Entering the second week of July, A-share and Hong Kong-listed pharmaceutical companies have successively announced their earnings forecasts, which can be described as a mixed bag of joy and sorrow.What other major events happened this week?NMPA Passes the Special Provisions on the Management of Traditional Chinese Medicine Standards:Recently, the National Medical Products Administration announced the issuance of the Specific Provisions on the Management of Traditional Chinese Medicine Standards (Announcement No. 93 of 2024). The Specific Provisions on the Management of Traditional Chinese Medicine Standards focus on establishing "the most rigorous standards" and set forth regulations from both policy and technical perspectives. These provisions integrate general requirements for drug standard management with the unique characteristics of TCM products, specifying fundamental principles for developing TCM standards, detailed requirements for various types of TCM quality standards, as well as procedures for revising and implementing standards. The provisions also clarify responsible entities and standardize key processes. The Specific Provisions on the Management of Traditional Chinese Medicine Standards will come into effect on January 1, 2025.The National Healthcare Security Administration Releases a List of Typical Issues Involving Illegal Use of Healthcare Security Funds:The official WeChat account of the "National Healthcare Security Administration" released a message on the 12th, stating that in April 2024, the National Healthcare Security Administration, together with the Ministry of Finance, the National Health Commission, and the National Administration of Traditional Chinese Medicine, issued the "Notice on Carrying Out the 2024 Medical Security Fund Fly-Check Work," officially launching the 2024 nationwide medical insurance fund fly-check work. At the same time, it summarized common illegal and regulatory violations in six fields: cardiology, orthopedics, blood purification, rehabilitation, medical imaging, and clinical laboratory. It distributed the "List of Typical Issues of Illegal Use of Medical Security Funds by Designated Medical Institutions" to various regions, requiring each province to follow the "List of Issues," combine it with local policies, organize self-inspection and self-correction within designated medical institutions in their jurisdictions, and promptly and voluntarily return the illegally used medical insurance funds.The First National Centralized Procurement of IVD Reagents in China is About to Begin:On July 9, the Jiangxi Provincial Medical Security Bureau issued a letter, titled "Invitation from the Jiangxi Provincial Medical Security Bureau to Participate in the Inter-Provincial Alliance Procurement of Biochemical Test Reagents such as Sugar Metabolism," inviting alliance provinces to participate, with a deadline of July 16. This will be the second nationwide medical device procurement project led by a provincial medical security bureau following Fujian, after the issuance of Document No. 8 on May 20 by the National Medical Security Bureau promoting the "quality enhancement and scope expansion" of centralized procurement. It is also the first nationwide IVD reagent procurement project.Lilly to Acquire Morphic for Approximately $3.2 Billion:On July 8, Eli Lilly and Morphic Therapeutics reached an acquisition agreement with a total transaction value of $3.2 billion. Morphic's lead program is the development of MORF-057, a selective oral small-molecule α4β7 integrin inhibitor for the treatment of IBD, which has the potential to improve patient outcomes and expand treatment options. MORF-057 is currently being evaluated in two Phase 2 studies for ulcerative colitis (UC) and one Phase 2 study for Crohn's disease. This acquisition will expand Eli Lilly's immunology pipeline.Return of Roche's Ranibizumab Implant:On July 8, Roche announced that the FDA had approved the post-approval supplement to the Biologics License Application (BLA) for Susvimo (ranibizumab implant, specification: 100mg/mL), which updates the component descriptions for the Susvimo ocular implant and refill needle. Roche will soon re-launch the updated version of Susvimo in the market, nearly two years after Susvimo was temporarily withdrawn.Amgen Terminates Development of CLDN6/CD3 Bispecific Antibody:On July 8, according to the clinicaltrials.gov website, Amgen has terminated (TERMINATED) the Phase I clinical trial (NCT05317078) of CLDN6/CD3 bispecific antibody AMG 794 for the treatment of Claudin 6-positive non-small cell lung cancer, ovarian cancer, and other malignant solid tumors. The reason is "Amgen has made a commercial decision to terminate the development of AMG 794. The safety profile of AMG 794 remains unchanged."Pfizer Chief Scientific Officer to Step Down:On July 9, Pfizer announced that the company is initiating a process to identify a successor for Dr. Mikael Dolsten, Pfizer's Chief Scientific Officer and President of Research and Development. This process is expected to last several months and may continue into early next year. Pfizer will seek a new Chief Scientific Officer from outside the company. Dr. Dolsten will assist in the search and continue in his current role until a successor is in place and a necessary transition is completed.Thermo Fisher Officially Announces New President for China:On July 8, Thermo Fisher announced via an internal email that Miguel Faustino had been appointed as President of China, effective August 1. In this role, he will report to Senior VP and President, Regions, Mark Smedley; Miguel and his family will relocate to Shanghai in early August. The former President of China, Hann Pang (Feng Shihan), will remain in China until the end of 2024 before returning to Singapore; Hann Pang’s next position within Thermo Fisher will be announced later this year.GSK China Vaccine Business Leader to Step Down:On July 9, Sherman Yu, Vice President of GSK and General Manager of China, announced a significant personnel change to employees. Peggy Fung, Vice President of GSK and Head of China Vaccine Business, has decided to leave GSK, with her last working day being August 9, 2024. The announcement revealed that Peggy Fung decided to leave GSK for personal reasons in order to be with her family in Hong Kong and achieve a better work-life balance.AbbVie Chief Scientific Officer Retires:On July 10, AbbVie announced that Roopal Thakkar, the current Senior Vice President of Global Therapeutics and Chief Medical Officer, will succeed Thomas J. Hudson as the company's Executive Vice President of Research and Development and Chief Scientific Officer. In the future, she will lead a global R&D organization with more than 14,000 employees, promoting the development of all product lines in pharmaceuticals and aesthetics businesses. She will also be responsible for six major R&D Centers of Excellence located in the United States, Germany, and Japan.Bayer to Complete Restructuring of Pharmaceutical Commercialization Team Within the Year:On July 10, Ross, the global head of commercialization for Bayer's pharmaceutical division, told foreign media that the company would essentially complete layoffs within its "pharmaceutical commercial team" by the end of this year. This is a year ahead of the overall layoff plan for the company. After the layoffs, Bayer will simultaneously promote a "Dynamic Shared Ownership (DSO)" management model to reduce management levels. On the same day, Zhou Xiaolan, Global Executive Vice President of Bayer Group’s Pharmaceuticals Division and President of Bayer Group in China, as well as President of Greater China, announced a major operational initiative to employees. Under Bayer’s push for the "DSO operational model," Bayer China will establish five business units (Core Product Business Team; Cardiovascular, Renal, and Metabolic Business Team; Women’s Health Business Team; Specialty Medicine Business Team; Retail Business Team) and six functional departments (Strategic Planning and DSO Transformation, Medical Affairs, Market Access, Distributor Management, Commercial Excellence Operations, Digital Innovation Team).Novo Nordisk's Once-a-Week Insulin Rejected by FDA:On July 10, Novo Nordisk announced that it had received a Complete Response Letter (CRL) from the FDA regarding the marketing application for its once-weekly insulin Icodec. The FDA's requests primarily concern manufacturing processes and the Type 1 diabetes indication. Novo Nordisk is in close communication with the FDA to meet these requirements, but the company expects that this will not be completed within this year. Icodec has already been approved for marketing in Europe, China, and other regions. Previously, the main issue discussed by the FDA advisory committee was the risk of hypoglycemia associated with the Type 1 diabetes indication. Although specific reasons were not disclosed in this CRL, the Type 1 diabetes indication was mentioned again, along with concerns about manufacturing.Pfizer Continues to Advance Oral GLP-1 Development:On July 11, Pfizer stated that based on the results of the ongoing pharmacokinetic study (NCT06153758), the preferred extended-release formulation for the oral GLP-1R agonist Danuglipron (PF-06882961) with once-daily dosing has been identified. In addition, Pfizer plans to initiate a dose optimization study of this extended-release formulation in the second half of 2024 to evaluate the efficacy and safety of multiple doses, providing reference for registrational studies.Neusoft Medical Receives Strategic Investment from China General Technology Group:Recently, the Capital Company affiliated with the General Technology Group, together with the China State-Owned Enterprise Mixed-Ownership Reform Fund Co., Ltd., signed an investment agreement with Neusoft Medical Systems Co., Ltd., strategically investing in Neusoft Medical. As a concrete practice of collaboration between central state-owned enterprises (SOEs) and private enterprises in the development of high-end medical equipment industry, this strategic cooperation marks the entry of the General Technology Group into the field of large-scale digital medical equipment R&D and manufacturing, achieving a strategic layout from medical services to medical technology. It also signifies that Neusoft Medical’s technological innovation capabilities, commercial value, and development potential have been fully recognized. This strategic cooperation is of great significance for the General Technology Group to accelerate the layout of strategic emerging industries, strengthen and expand the pharmaceuticals and healthcare industry, and expedite Neusoft Medical’s leapfrog development.Hengrui's Second HER2 ADC Initiates Phase II Clinical Trial with 240 Participants:On July 9, Hengrui Medicine registered the phase II clinical trial of SHR-4602 on the Drug Clinical Trial Registration and Information Disclosure Platform website. According to the information disclosed by Hengrui Medicine at this year's AACR, SHR-4602 is a new HER2 ADC drug, with a molecular design of pertuzumab conjugated with an eribulin derivative. The design goal is for later-line treatment in patients resistant to DS-8201 or SHR-A1811. Preclinical studies have shown that SHR-4602 still exhibits excellent anti-tumor activity in DS-8201 and SHR-A1811-resistant JIMT-1 models. SHR-4602 was submitted for approval in January 2023 and received clinical approval in April.Simcere Pharmaceutical's Oral Anti-COVID Drug Receives Full Approval:On July 11, Simcere Pharmaceutical announced that Xianorin (a combination package of Xianortrelvir Tablets and Ritonavir Tablets) has been granted regular approval by the National Medical Products Administration (NMPA) after transitioning from conditional approval. It is indicated for the treatment of adult patients with mild to moderate Coronavirus Disease 2019 (COVID-19). Xianorin has become the first orally administered anti-COVID-19 drug in China to receive regular approval.Yuyan Company and Ipsen Reach ADC Product Collaboration Worth Over $1 Billion:On July 11, Ipsen and Foreseen Biotech jointly announced that they had reached an exclusive global licensing agreement for the ADC product FS001. According to the terms of the agreement, Foreseen Biotech will receive up to $1.03 billion, including an upfront payment, milestone payments for development, regulatory, and commercial achievements, as well as tiered royalties on global sales following successful development and regulatory approval. Ipsen has obtained exclusive rights to develop, manufacture, and commercialize FS001 globally. Ipsen will be responsible for Phase I preparatory activities for FS001, including submitting the Investigational New Drug (IND) application, as well as all subsequent clinical development, manufacturing, and global commercialization activities.Fosun Pharma Claims 2.55 Billion Yuan from Ailis:On July 10, Ailis announced the receipt of an arbitration notice. The announcement revealed that recently, Fosun Pharma filed an arbitration application with the Shanghai International Economic and Trade Arbitration Commission under agreements such as the "Exclusive Promotion Agreement," requesting a ruling for Ailis to pay promotional service fees, legal fees, return the deposit, and compensate, totaling 255 million yuan. The arbitration case mainly arises because Jiangsu Fosun previously had exclusive sales rights for Ailis' core product, Fomepafenib Mesylate Tablets. Ailis believes that during this period, Jiangsu Fosun committed multiple breaches of the agreement, preventing the realization of the contract’s purpose. As a third-generation lung cancer drug, Fomepafenib is considered a "blockbuster product" in the field of oncology drugs in terms of commercial performance. According to data from Guotai Junan, Fomepafenib's sales in 2023 were close to 2 billion yuan.In-body CAR-T therapy enters human clinical trials for the first time:On July 10, Interius BioTherapeutics announced that it had received approval from the Human Research Ethics Committee (HREC) of the Australian Therapeutic Goods Administration (TGA) and a Clinical Trial Notification (CTN) authorization to conduct a Phase 1 clinical trial of its investigational in vivo CAR-T therapy, INT2104, for the treatment of B-cell malignancies. Interius plans to initiate the trial in the fourth quarter of 2024 and expects to reach a key milestone in the first quarter of 2025.Amylyx Acquires GLP-1R Antagonist:On July 10, Amylyx announced that it would acquire Avexitide from Eiger BioPharmaceuticals for $35.1 million. If Avexitide is approved for marketing in the future, Amylyx will also need to pay a 3% royalty on sales of Avexitide for the post-bariatric hypoglycemia (PBH) indication to certain academic institutions.Connie Bio 1.85 Billion USD Overseas Launch of Two Bispecific Antibodies:On July 9, Keymed Biosciences announced on its official website that the company had entered into a licensing agreement with Belenos Biosciences (“Belenos”) for two self-developed bispecific antibodies. According to the terms of the agreement: Keymed Biosciences grants Belenos exclusive rights to develop, manufacture, and commercialize preclinical drugs CM512 and CM536 globally (excluding Greater China). As consideration, Keymed Biosciences will receive an upfront payment and near-term payment totaling US$15 million, while its wholly-owned subsidiary, Yiqiao Hong Kong Holding Limited, will acquire approximately 30.01% of Belenos’ equity. Additionally, based on the achievement of development, regulatory, and commercial milestones for the projects, Keymed Biosciences is also eligible to receive up to US$170 million in additional payments.Sirnaomics' $20 Million Investment in Financial Products Explodes:On July 8, Hong Kong Stock Exchange 18A-listed Sirnaomics announced: Due to the potential default of the private debt issuer invested in by the fund subscribed by the company, a significant loss in the investment fund is expected. This is a private equity fund in which Sirnaomics has invested a total amount of US$20 million. The fund is managed by TradArt Flagship Investment SPC. Sirnaomics stated that as of the date of the announcement, the company had only redeemed US$200,000. The Board has established an investigation committee and reserved the right to hold the fund management accountable in order to mitigate the losses caused by this incident.Wantai Bio Performance Drops by 80%:On July 10, Wantai Bio announced its 2024 semi-annual earnings forecast: In the first half of this year, the company expects to achieve a net profit attributable to shareholders of approximately 240 million yuan to 290 million yuan, a decrease of 1.412 billion yuan to 1.462 billion yuan compared with the same period last year, representing a decline of 83%-86%. Wantai Bio explained that in the vaccine sector, the revenue and profits of the bivalent HPV vaccine continued to decline year-on-year due to the expanded age range for the nine-valent HPV vaccine, increased market competition, and inventory reduction. The diagnostics sector performed steadily overall.North China Pharmaceutical Expects 164% Year-on-Year Increase in Net Profit for the First Half:On July 10, North China Pharmaceutical announced that it is expected to achieve a parent company net profit of approximately 70 million yuan in the first half of 2024, representing a year-on-year increase of 164%. The company noted that the reasons for the growth in performance are the implementation of measures such as adjusting the product structure, strengthening procurement management, reducing procurement costs, promoting lean management, and deeply exploring cost and expense control, which have led to an improvement in profitability.Flagship Raises $3.6 Billion for Biotech Investments:On July 10, life sciences investment firm Flagship Pioneering announced it had raised $3.6 billion to create and advance approximately 25 groundbreaking new companies. The company also announced the promotion of nine employees to partner roles and the appointment of five new senior executives. This funding includes $2.6 billion allocated for Flagship's eighth flagship fund and $1 billion for a sidecar fund.Biokin's HKEX IPO Application Accepted by HKEX:On July 10, Biokin's Hong Kong IPO prospectus was officially released. As of the closing on July 9, Biokin's market value at the Shanghai Stock Exchange exceeded 69 billion yuan. This marks Biokin’s second IPO application a year after its listing on the STAR Market, which will further expand Biokin’s international development. Currently, Biokin has six ADC new drugs, including BL-B01D1, in the clinical stage, with approximately 60 clinical studies underway, including nine late-stage Phase III clinical trials and thirteen first-line Phase II clinical trials. Meanwhile, in terms of multispecific antibody drugs, four GNC multispecific antibodies have entered the clinical stage, with ten clinical studies initiated."Chronic Disease Management Platform" Ark Jianke Officially Listed on the Hong Kong Stock Exchange:On July 9, chronic disease management platform Ark Cloud Health went public on the Hong Kong Stock Exchange, with an issue price of HK$8.18 per share. It opened 41.6% lower at HK$4.68; by the close of trading that day, each share had fallen 44.62% to HK$4.53, giving it a total market value of HK$6.071 billion. The prospectus shows that, based on average monthly active users in 2023, Ark Cloud Health is China's largest online chronic disease management platform, providing comprehensive medical services and online retail pharmacy services through the Jianke platform. Additionally, it offers customized and marketing solutions for pharmaceutical companies, committed to providing tailored medical care and precision medicine for the growing number of chronic disease patients.First Trial | Huang Jia
Second Review | Li Fangchen
Third Review | Li Jingzhi
