Pfizer Re-enters Weight-Loss Market; Borui's Novel Dual-Agonist Challenges Novo Nordisk; Bayer Completes Commercial Restructuring

A Total of 4 Brief News Items | Reading Time Approximately 4 Minutes◆◆ ◆

01

Qilu Pharmaceutical Accelerates Product Layout

The oncology market, as a potential market that large pharmaceutical companies must compete for, has always been highly focused on the layout surrounding major varieties.

Recently, the official website of the National Medical Products Administration released an announcement, declaring that Qilu Pharmaceutical's Trastuzumab for Injection (trade name: Anquluo) has officially received marketing authorization approval. This drug will be used for the treatment of HER2-positive early breast cancer, metastatic breast cancer, and metastatic gastric cancer.

In fact, Bevacizumab (Avastin), Rituximab (Rituxan), and Trastuzumab (Herceptin) have long been the three major brand drugs in Roche's product portfolio, also known as the "three pillars" of Roche's oncology field. Particularly, Trastuzumab holds a cornerstone position in the HER2 drug domain.

However, as the HER2 drug field continues to face price competition from biosimilars and direct challenges from ADC (antibody-drug conjugate) products, the pressure on Roche's branded drugs has increased significantly. Before the approval of Qilu Pharmaceutical's product this time, four companies' trastuzumab biosimilars had already received marketing approval.

Market analysis suggests that the field of biosimilars in China is experiencing vigorous growth. Numerous pharmaceutical companies are already competing for market share with biosimilar products of rituximab and bevacizumab. Policy-driven bulk procurement of biosimilars will also intensify price competition. In the HER2 drug market, whether it's trastuzumab biosimilars, pertuzumab biosimilars, or innovative products represented by subcutaneous injections and ADCs, all are further reshaping the competitive landscape.

Qilu Pharmaceutical Accelerates Product Layout

The market impact on Roche's "troika" begins with bevacizumab.

Qilu Pharmaceutical successfully obtained approval for the first domestically produced Bevacizumab (trade name: Ankeda) in 2019. Data shows that the Bevacizumab biosimilar achieved sales of 1.8 billion yuan in its first year on the market, drawing significant industry attention.

In the therapeutic area of rituximab, although Qilu Pharmaceutical has not directly developed biosimilars, its recently approved Bendamustine Hydrochloride Concentrated Solution for Injection (brand name: You Ran) has made progress in the indication of indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or after treatment with rituximab or rituximab-containing regimens.

The trastuzumab approved this time by Qilu Pharmaceutical has launched an offensive against Roche's heavyweights in the HER2 field clinical treatment.

As a HER2-targeted monoclonal antibody developed by Roche, the original drug Herceptin has become the cornerstone of HER2-positive breast cancer treatment since its FDA approval in 1998. By specifically binding to the HER2 receptor, it effectively blocks tumor cell proliferation signals, significantly improving patient survival rates.

According to incomplete statistics, Herceptin has accumulated sales of over 97 billion Swiss francs since its market launch, with peak annual sales exceeding 7 billion Swiss francs. However, with the expiration of the original product's patent and the subsequent approval of several biosimilars, the "patent cliff" has gradually challenged its market share.

Data shows that Qilu Pharmaceutical's trastuzumab biosimilar was initiated for research in 2017, using the same Chinese hamster ovary (CHO) cell expression technology as the original trastuzumab. During the non-clinical research phase, the pharmacokinetic characteristics, safety, and immunogenicity of this biosimilar in cynomolgus monkeys were highly similar to those of the original drug.

In terms of efficacy evaluation, the objective response rates (ORR) at 24 weeks for Qilu Pharmaceutical's trastuzumab biosimilar and the control group were 59.7% and 56.1%, respectively, with a risk ratio (RR) of 1.065, falling within the pre-set equivalence margin (0.8–1.25), fully demonstrating its similarity in efficacy to the reference product.

Industry insiders said that with the continuous development of biopharmaceutical technology and the enhancement of innovation capabilities in China, an increasing number of companies have started to venture into the research and production of biosimilars such as trastuzumab for injection. The entry of these companies not only enriches product options in China's pharmaceutical market but also provides patients with more cost-effective and reliable treatment solutions, which is expected to benefit a broader patient population.

From Similar Drugs to ADC: Multi-Product Competition

Injectable Trastuzumab is a major blockbuster in anti-tumor drugs. In 2023, the sales of injectable trastuzumab in Chinese urban public hospitals, county-level public hospitals, urban community health centers, and township health clinics reached 6.8 billion yuan, with a growth rate of 4.52%.

As China-produced biosimilars of trastuzumab for injection have been successively approved and launched, Roche must face an increasing number of market competitors. Currently, trastuzumab products available in China are provided by multiple pharmaceutical companies. In addition to Roche, Henlius, Anke Bio, Biocytogen, CTTQ, and Qilu Pharmaceutical have already sounded the horn for the market competition.

However, as a pioneer in HER2-targeted therapy, Roche obviously does not want to give up easily. In the HER2 product field, in addition to trastuzumab, the market launch of pertuzumab and the "dual-target" treatment regimen, as well as the approval and inclusion of subcutaneous injection products into medical insurance, still extend the product lifecycle in this niche to a certain extent. Earlier this year, Roche's subcutaneous formulation combining trastuzumab and pertuzumab (Herceptin Hylecta) was approved for marketing in China. This product not only combines the two drugs, pertuzumab and trastuzumab, but also further simplifies the treatment process.

Notably, pertuzumab has also gained attention and strategic focus from pharmaceutical companies in China. Multiple pharmaceutical enterprises have started developing biosimilars of the drug and have made significant progress.

Previously, Qilu Pharmaceutical Co., Ltd. has already submitted the first marketing application for a pertuzumab biosimilar (QL1209) in China. Other domestic pharmaceutical companies such as Zhengda Tianqing, Shijiazhuang Pharmaceutical Group, Henlius, Double-Crane Pharmaceuticals, and Hisun Pharmaceutical are also accelerating the research and development process of biosimilars for this product.

If the market pressure brought by the competition of biosimilars in the HER2 product field is more reflected in pricing, the emergence of novel ADC drugs has also caused considerable trouble for Roche.

AstraZeneca/Daiichi Sankyo's Trastuzumab Deruxtecan (DS-8201) has become an undeniable presence, with strong clinical data and treatment outcomes likely to bring about a disruptive shift in the HER2 market.

Hengrui Medicine, a leading enterprise in China's innovative drug sector, has also made significant advances in the field of HER2-positive breast cancer. Its developed drug, Pyrotinib, as a highly selective HER2 TKI, has demonstrated good efficacy in combination therapy regimens; additionally, Hengrui is also making strides in the ADC drug sector, such as with Recombinant Trastuzumab (SHR-A1811), further enriching its product pipeline. Kelun Pharmaceutical’s efforts in this area are mainly concentrated in ADC drugs, with its developed Injectable A166 (Bodu Trastuzumab) becoming the first domestically produced HER2 ADC for breast cancer to be submitted for marketing approval in China.

Rongchang Bio recently announced that Disitamab Vedotin (trade name: Aidixi®) achieved positive results in the Phase III clinical trial for treating HER2-positive advanced breast cancer patients with liver metastases, reaching the primary endpoint. The company plans to submit a marketing application to the CDE soon.

(Source: Pharmaceutical Economy Report)

02

Bayer to Complete Restructuring of Pharmaceutical Commercialization Team Within the Year

On July 10, Ross, the global commercialization head of Bayer's pharmaceutical division, told foreign media that the company would basically complete layoffs in its "pharmaceutical commercial team" within this year. This is one year ahead of the company's overall layoff plan.

After the layoffs, Bayer will simultaneously promote a management model called "Dynamic Shared Ownership" to reduce management levels, abbreviated as DSO. According to foreign media reports, in Bayer's U.S. pharmaceuticals division alone, 40% of management positions will be at risk of elimination. More decisively than expected, new job responsibilities for the remaining staff will be implemented by the end of this year.

Nowadays, Bayer's determination to transform is unshakable, and there is already a trend of expanding to other regions. It is reported that Bayer China may also implement the DSO system adjustment, which has started from June this year, and the selection results of relevant personnel at all levels of each business department will be announced successively.

It is imminent that the hurricane of Bayer's global layoffs will land in China.

Each reported project has to go through 12 levels of management.

Under the DSO operating model, the scale of layoffs disclosed by Bayer this time is not small. After the reorganization of the pharmaceutical division’s commercial team, Bayer plans to integrate the sales teams that previously handled products with other parallel functional teams. For instance, functions such as marketing, market access, medical affairs, and patient advocacy will be unified under Global Capability Teams, replacing the single-product group model, with expected goals set.

In other words, with fewer people in the commercialization team, each person ends up with more tasks.

At the same time, other positions in the pharmaceutical sector are also being adjusted. In Bayer's pharmaceutical division, the responsibilities of employees in late-stage development, registration, commercialization, and lifecycle management are being reshaped, with regulatory and development functions transferring to the R&D department.

Bayer's DSO model adjustment is global, and China may be the next stop. Industry sources revealed that on July 10, Zhou Xiaolan, Global Executive Vice President of Bayer Group’s Prescription Drug Division and President of Bayer Group in China, as well as President of Bayer Greater China, announced a major operational initiative to employees: Bayer China will be restructured into five business units and six functional departments.

Specifically, the five major business units include: the Core Product Business Team, responsible for products such as Verquvo, Adalat, Xarelto, and Kovaltry; the Cardiovascular, Renal, and Metabolic Business Team, responsible for Kerendia and Hua Tang Ning; the Women's Health Business Team, responsible for women’s health products across all channels; the Specialty Medicine Business Team, responsible for Eylea and the entire oncology portfolio; and the Retail Business Team, responsible for the commercial operations of all Bayer prescription drugs in retail channels. Additionally, the six key functional departments include: Strategic Planning and DSO Transformation, Medical Affairs, Market Access, Distributor Management, Excellence in Commercial Operations, and Digital Innovation Team.

Insiders revealed that Bayer China will successively announce the selection results of relevant personnel at all levels in each business unit, and all will be completed before the end of September this year. At that time, Bayer China is bound to undergo a "slimming down" process akin to a bloodbath.

Notably, the DSO's new operational model was only introduced in January this year. Prior to this, Bayer had to navigate through as many as 12 layers of corporate management to report a single project. The convoluted system caused significant internal inefficiencies within Bayer, and the restructuring required adjusting a large number of personnel.

After adjustment, the prenatal vitamin group can compress the project time from 21 months to 7 months, greatly improving the company's operational efficiency.

After reorganization, the process can reduce 80 pages of materials.

Currently, Bayer China has not yet responded to the news of this structural adjustment. However, since the group level has already decided to complete the adjustment of the pharmaceutical commercialization team by the end of the year, it is believed that internal actions have already begun.

The industry is concerned about how to achieve self-sufficiency if Bayer's subsequent product commercialization capabilities decline?

Currently, Bayer has launched a product commercialization team under the new DSO operational model, placing its hopes on the prostate cancer drug Darolutamide and the menopause drug Elinzanetant.

Some analysts predict that the peak sales of darolutamide will exceed 3 billion euros annually. Bayer is attempting to expand the scope of darolutamide through a Phase III trial for metastatic hormone-sensitive prostate cancer, which was preliminarily completed on June 7. Bayer stated that under the DSO model, the drug's submission process requires about 80 fewer documents. The "potential blockbuster drug" elinzanetant will also break away from the original channel to directly market to consumers.

The acceleration of the process will undoubtedly help Bayer enhance its pharmaceutical commercialization capabilities, but whether it can achieve the desired results still needs to be validated over time.

In addition, Bayer stated that the DSO model is expected to advance early-stage projects more quickly. "The core of the DSO strategy is to continue investing and addressing pipeline gaps," said Ross, Head of Global Commercialization at Bayer Pharmaceuticals. The restructured Bayer has a clear vision of its future areas of focus. In March this year, Bayer disclosed updates on its 2023 R&D pipeline, with four drugs showing first-in-class potential globally anticipated to enter Phase II clinical trials by the end of 2024 in the fields of cardiovascular diseases, oncology, immunology, as well as neuroscience and rare diseases.

Bayer once envisioned: achieving $10 billion in cancer drug revenue by 2030. However, as key products like Xarelto and Eylea face the patent cliff one after another, the company lacks blockbuster drugs, and its pharmaceutical segment is gradually weakening. Among the top three best-selling products of the pharmaceutical division last year, none were from the oncology pipeline. Under the new DSO system, can Bayer make a short-term comeback?

(Source: Jian Shi Ju)

03

Pfizer Re-enters the Weight Loss Drug Market

Pfizer, a world-renowned pharmaceutical company, has decided to enter the lucrative weight-loss drug market in order to improve its sluggish performance post-pandemic and achieve a turnaround.

First, Pfizer assessed the prospects of the weight-loss drug market. Pfizer anticipates that the weight-loss drug market will grow to approximately $130 billion within the next decade, with oral tablets expected to capture about one-third of this market. Consequently, Pfizer aims to compete with Novo Nordisk and Eli Lilly's popular weight-loss injectables by developing an oral weight-loss drug called danuglipron. This oral medication, which does not require injections, has the potential to rival traditional injectable drugs.

However, Pfizer has made little progress in the treatment of obesity. In December last year, Pfizer halted the development of its twice-daily Danuglipron treatment after many patients in a mid-stage study involving about 1,400 people dropped out due to side effects such as nausea and vomiting. A few months earlier, Pfizer had also abandoned another oral weight-loss drug after trials found it had an adverse effect on the liver.

Thus, Pfizer began a new attempt. On Thursday, July 11, Eastern Time, Pfizer announced a small study involving 20 participants, testing four different formulations to reduce the drug's dosing frequency from twice daily to once daily, in order to determine which formulation might be the most effective. Although the company did not disclose which formulation worked best, stating only that one formulation showed "the most favorable profile," outgoing Chief Scientific Officer Mikael Dolsten noted that several versions of the drug yielded "encouraging" results, expressing confidence that "a once-daily formulation has competitive potential in the weight-loss drug market."

Affected by this news, Pfizer's stock price rose nearly 6% before the U.S. stock market on Thursday, and the increase expanded to 3.1% at the beginning of the trading session, then halved.

Looking ahead, Pfizer plans to advance this drug into the mid-stage research phase in the second half of this year. Some analysts had originally believed that, in order to close the gap with Eli Lilly and Novo Nordisk, Pfizer might skip this step and move directly into the later-stage research phase in hopes of gaining regulatory approval as soon as possible. The company stated that the next trial will aim to identify the optimal dosage of the drug, and if successful, it will move into the final development stage.

However, Sam Fazeli, head of media intelligence research, said that in the best-case scenario, the drug might not hit the market until 2028, by which time there could already be multiple competitors.

Declining Performance and Departure of Chief Scientific Officer: Pfizer Shrouded in "Gloom"

Pfizer CEO Albert Bourla Faces Mounting Pressure as Investors Doubt Ability of New Drug Pipeline to Reverse Post-Pandemic Revenue Decline

Pfizer Just Announced That Mikael Dolsten, Chief Scientific Officer for 15 Years, Is Leaving. Under His Leadership, Pfizer Developed Blockbuster Drugs Like Eliquis and Prevnar, But These Are Now Facing Intense Competition, And Pfizer Has Yet to Find New Products to Replace Them.

During the pandemic, Pfizer's COVID-19 vaccines and drugs generated over $100 billion in sales within just two years, providing the company with a brief respite. However, this success did not last. Market demand for booster shots plummeted, and Pfizer had to withdraw large quantities of its drugs from the government last year. Currently, the company’s stock price is near its lowest point in a decade.

What do analysts think?

The media pointed out that, in contrast, Pfizer lags behind Novo Nordisk and Eli Lilly. Eli Lilly's once-weekly injectable drug Zepbound was approved in the United States last year, and the market anticipates high sales. Eli Lilly also has an oral weight-loss medication that has entered the final stage of development, with key trials expected to conclude in April. Besides, market competition is fierce, as AstraZeneca, Structure Therapeutics, and other companies are also developing oral weight-loss drugs.

As Pfizer did not immediately respond to inquiries about whether it would release more detailed research data on danuglipron, analysts, lacking specific information, found it difficult to accurately assess the results of the study. Therefore, analysts have remained relatively cautious about this progress by Pfizer.

Jefferies analyst Akash Tewari pointed out that some key questions surrounding danuglipron remain unanswered. Evercore analyst Umer Raffat believes that Pfizer may be "buying time" to observe the performance of another weight-loss drug it is studying.

Wall Street has been pinning its hopes on weight-loss drugs, viewing them as a way for companies to achieve a recovery in performance. They have been constantly probing Bourla about the company's plans in the weight-loss drug market. During Pfizer's earnings call last quarter, analysts raised this question four times in various creative ways. One of them even mentioned a job posting on the company’s website seeking clinicians with experience in weight-loss drugs.

Pfizer will release its earnings report later this month, giving analysts an opportunity to further discuss the research findings published this Thursday and its future in the weight-loss drug market.

(Source: Wall Street CN)

04

BrightGene's Weight Loss Drug Challenges Novo Nordisk

Good news again for weight-loss drugs with multiple targets produced in China.

On July 9, preliminary blinded results from two Phase II clinical studies of BGM0504, a weight-loss drug developed by BrightGene Bio-Medical (688166), showed that in patients with type 2 diabetes and in overweight/obese patients, indicators such as HbA1c, fasting blood glucose, and 2-hour postprandial blood glucose significantly decreased from baseline across all dose groups. Additionally, the body weight of subjects in all dose groups also significantly decreased from baseline.

In just 18 months, BGM0504 injection completed the remarkable progress from clinical trial approval to Phase III clinical research.

It is worth mentioning that, among the current GLP-1 class of drugs, domestic companies in China are involved in both generic drug development and independent innovation of new drugs. Generic drug development mainly focuses on liraglutide and semaglutide, while the independent innovation of new drugs centers on multi-target and multi-agonist GLP-1 drugs, which have high research and development thresholds and are protected by patents.

Although the compound patent for Novo Nordisk's semaglutide is not set to expire until 2026, there are already at least dozens of Chinese generic versions in clinical stages. Abhijit Zutshi, Chief Commercial Officer of Indian pharmaceutical giant Biocon, stated that they are researching innovative methods for drug synthesis, filling, and manufacturing injection devices, which could potentially reduce costs by at least half and might eventually bring the price down to one-tenth of the current drug’s selling price.

Therefore, every research and development advancement in China's multi-target agonist weight-loss drugs can not only avoid the intense competition in the semaglutide generic drug market but also secure a share in the global weight-loss market as a patented drug.

Clustering

On June 25, the National Medical Products Administration (NMPA) approved Novo Nordisk's Wegovy (semaglutide injection for long-term weight management) for marketing in China. This is currently the world’s first and only once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist approved for long-term weight management, achieving an average weight loss of 17% (16.8 kg) and offering patients multiple health benefits beyond weight reduction. Its safety has been widely validated.

In 2023, the sales of Novo Nordisk's Ozempic in China more than doubled, reaching approximately USD 700 million, accounting for 5% of the drug’s global total sales. The total sales of Ozempic in 2023 reached about USD 21.158 billion. Among this, the sales of Wegovy injection for obesity amounted to approximately USD 4.548 billion, a year-on-year increase of 407%. In the first quarter of 2024, according to Novo Nordisk's announced Q1 2024 performance, the sales of semaglutide reached an astonishing USD 6.1 billion. Among this, the sales of the weight-loss version of semaglutide injection (Wegovy) achieved a year-on-year doubling, reaching DKK 9.377 billion, equivalent to approximately USD 1.363 billion.

With the official approval of Novo Nordisk's Wegovy in China, this data is expected to continue growing significantly.

However, as the patent for Semaglutide in China is set to expire in 2026, records from clinical trial websites indicate that at least 15 generic versions of Semaglutide have entered clinical trials in China, with at least 11 reaching the later stages of clinical trials. Companies that have completed or are currently recruiting for Phase III clinical trials include: Hangzhou Jiuyuan Gene Engineering, Livzon Group, Chenan Biotech/Bowei Biotech, CSPC Pharmaceutical Group, Huadong Medicine, China National Biotech Group, Qilu Pharmaceutical, and others.

In April this year, the marketing application for "Jiuyou Tai," a semaglutide injection submitted by Hangzhou Jiuyuan Gene Engineering Co., Ltd. ("Jiuyuan Gene"), was accepted. This is China's first reported biosimilar of semaglutide to be marketed. In June of the same year, the marketing application for a semaglutide injection from Livzon Group Xinpjiang Pharmaceutical Co., Ltd. ("Livzon Group") was also accepted, making it the second company to report its product for marketing after Jiuyuan Gene.

Relevant data shows that there are more than 100 GLP-1 drugs under development globally, with nearly half coming from pharmaceutical companies in China. Some industry insiders have expressed concerns: With the boost from capital, could the GLP-1 market face a repeat of the clustering and homogenization issues seen with PD-1-targeted cancer drugs?

Innovation

After the popularity of the "weight-loss wonder drug" Semaglutide, reports emerged about its side effects such as loss of appetite, depression, and high rebound rates. A new diabetes drug, "Tirzepatide," has gradually captured public attention. It is claimed that this new drug shows relative advantages in these side effects and demonstrates better weight-loss results. Clinical studies report an average weight loss of 48 pounds over 72 weeks.

Behind Tirzepatide is another pharmaceutical giant, Eli Lilly. Compared to the single-target Semaglutide, Eli Lilly directly adopted a more advanced dual-target (GLP-1R/GIPR) approach. Mounjaro, the version of Tirzepatide for treating type 2 diabetes, and Zepbound, the weight-loss version, were launched in the U.S. in 2022 and 2023, respectively. Last year, these two products generated over $5 billion in revenue and are expected to rank among the best-selling drugs in history, alongside Novo Nordisk's similarly effective drug, Semaglutide. As a result, Eli Lilly's valuation surged, with its market capitalization approaching $850 billion, making it the most valuable pharmaceutical company globally.

Compared with single-target GLP-1 agonist drugs such as semaglutide, tirzepatide can simultaneously activate GLP-1 and GIP receptors, theoretically providing better control of blood sugar and weight. In clinical trials, it has demonstrated the most effective weight loss data among current non-head-to-head GLP-1 class drug studies.

According to a clinical study on tirzepatide, different doses (5mg, 10mg, 15mg) of tirzepatide can significantly and continuously reduce body weight in obese patients, with the highest dose group achieving an average weight loss of 48 catties over 72 weeks.

For semaglutide, The New England Journal of Medicine (NEJM) published the results of the STEP 3a phase clinical trial, which involved 4,500 obese or overweight adult patients without type 2 diabetes. Obese patients receiving semaglutide treatment experienced an average weight loss of 17% (16.8 kg) over 68 weeks. The trial demonstrated that the treatment was safe and well-tolerated.

From the target perspective, semaglutide is a single-target drug (GLP-1). GLP-1 is a neuroendocrine hormone secreted by the small intestine after eating. It promotes insulin secretion in a glucose-dependent manner, inhibits glucagon secretion, delays gastric emptying, increases satiety, and reduces food intake.

The dual targets of Tirzepatide lie in the addition of GIP, a peptide composed of 42 amino acids that exerts its effects through the GIP receptor (GIPR). GIPR is widely expressed, with locations including but not limited to the pancreas, stomach, bones, small intestine, adipose tissue, lungs, and multiple regions of the central nervous system. The most well-defined role of GIP is in the pancreas, where it promotes insulin secretion in a glucose-dependent manner. At the same time, it can also regulate glucose concentration dependence, preventing blood sugar from dropping too low.

A month ago, Eli Lilly's tirzepatide was approved for marketing in China, with the diabetes indication approved to improve blood sugar control in adult patients with type 2 diabetes. The weight loss indication is still awaiting approval.

Perhaps inspired by Eli Lilly's "Tirzepatide," many pharmaceutical companies in China have adopted a multi-target R&D approach when entering the weight-loss drug market. This strategy not only avoids the crowded field after the expiration of Semaglutide’s patent but also allows them to develop a class of innovative drugs with unique advantages, enabling them to compete globally with Novo Nordisk and Eli Lilly as patented drugs in the weight-loss pharmaceutical arena.

Speed

Currently, GLP-1 class drugs are fiercely competitive in China. In addition to several companies developing liraglutide and semaglutide analogs, the research and development of weight-loss drugs in China still mainly focus on single-target GLP-1. Some companies with deep involvement in this field have expanded their layout to include dual-target GLP-1/GIP, GLP-1/GCGR, and even triple-target approaches, seeking differentiated competition.

As a rising star in multi-target weight loss drugs, BrightGene Bio-Medical Technology's self-developed GLP-1/GIP dual agonist product BGM0504 injection is a dual agonist of GLP-1 (glucagon-like peptide 1) and GIP (glucose-dependent insulinotropic polypeptide) receptors. It is an innovative chemical drug classified as Category 1 with independent intellectual property rights protection and has not been marketed either domestically or overseas.

According to the latest release from CRO company Novo Demei, Professor Ji Lirong, a leading figure in endocrinology at Peking University People's Hospital, emphasized that BGM0504 injection, with its novel and unique dual-target mechanism, is expected to provide more comprehensive and effective treatment options for patients with diabetes and obesity.

Currently, BGM0504 Injection is in Phase III clinical trials. Preliminary results from the double-blind Phase II clinical studies of BGM0504 Injection in patients with type 2 diabetes and overweight/obese patients indicate that after dose titration over 2 to 6 weeks, followed by 12 weeks of treatment at target doses of 5mg, 10mg, and 15mg, the drug showed good tolerability and safety. Significant reductions from baseline were observed in indicators such as HbA1c, fasting blood glucose, and 2-hour postprandial blood glucose across all dose groups. Additionally, subjects in all dose groups experienced significant weight loss compared to baseline.

As early as the previously completed Phase Ia clinical trial, at doses of 2.5-15 mg, after 1 to 2 administrations, the average weight of healthy volunteers decreased by 3.24%~8.30% compared to baseline. Within the dose-escalation range of 2.5-15 mg for the BGM0504 injection, its exposure levels (including Cmax and AUC0-t) were higher than those of tirzepatide at equivalent doses. It is claimed that BGM0504 is an "enhanced version" of tirzepatide.

Currently, Masmorin (IBI362), a GLP-1R/GCGR dual agonist co-developed by Innovent Biologics and Eli Lilly, has reached the primary endpoint in its Phase 3 clinical trial (DREAMS-2) conducted among Chinese subjects with type 2 diabetes. It demonstrated significant glucose-lowering efficacy and showed comprehensive advantages in metabolic indicators such as weight loss.

Innovent Biologics plans to read out another Phase 3 DREAMS-1 clinical study result by mid-2024 and submit a new drug application to China's NMPA for the treatment of type 2 diabetes with Mazdutide. The first weight loss indication is also under review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA).

Hengrui Medicine's product HRS9531, a GLP-1R/GIPR dual agonist, has now entered Phase III clinical trials for obesity and is expected to complete the study by July 2025.

DR10624, a product of Huadong Medicine, is a GLP-1R/GCGR/FGF21R triple agonist. It has been approved for clinical trials in China and is intended for weight management in overweight or obese populations. Previously, a Phase 1 clinical trial was conducted in New Zealand to evaluate its safety and tolerability, among other factors. DR10624 is a potential "first-in-class" drug with triple agonistic activity, exerting synergistic effects by simultaneously modulating three receptor-mediated signaling pathways to achieve blood glucose reduction, weight loss, and lipid-lowering effects.

Compared with single-target drugs, multi-target drugs have greater potential and advantages in treating complex diseases such as obesity. Therefore, an increasing number of companies are beginning to enter the multi-target weight-loss drug market. In China, companies focus on independent innovation in the research and development of multi-target weight-loss drugs while actively cooperating with well-known international enterprises. This cooperation model helps accelerate the drug development process and enhance the competitiveness of the drugs.

According to Barclays' forecast, the global market size for GLP-1 drugs treating obesity is expected to reach $100 billion by 2030. JPMorgan Chase also raised its sales forecast for weight-loss drugs, predicting that annual sales of GLP-1 receptor agonist drugs will exceed $100 billion by 2030. With the growing severity of obesity and increasing attention to health management, the demand for weight-loss solutions will continue to grow.

Due to the vigorous efforts of Chinese pharmaceutical companies such as Innovent Biologics, Hengrui Medicine, BrightGene Bio-Medical Technology, and Huadong Medicine, these companies have adopted multi-target research and development for glycemic control and weight loss indications. In the competitive landscape with pharmaceutical giants like Eli Lilly and Novo Nordisk, they have adopted a strategy of both cooperation and competition. In the future, in the vast global market for glycemic control and weight loss, there will definitely be Chinese enterprises competing for a share of the $100 billion market. We will wait and see.

(Source: Yaoke Network)