YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 524 drug applications between 3 January 2025 and 9 January 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 204, covering 145 drug names.
2025/01/03 – 2025/01/09
- New acceptances this week
- 524
- Drugs with new generic filings (by drug name, de-duplicated)
- 145
- Accepted this week, now under review
- 19
DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.
Names with a public page are linked.
New acceptances this week
By application type and drug type
524filings, 204 of them generic
By application type
| Application type | Filings |
|---|---|
| Generic | 204 |
| Supplement | 204 |
| New drug | 88 |
| Import | 17 |
| Unspecified | 5 |
| Import re-registration | 5 |
| Drug-device combination | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 384 |
| TCM | 69 |
| Therapeutic biologic | 61 |
| Prophylactic biologic | 8 |
| Biologic | 2 |
DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.
Most new generic filings, by drug
145 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Metformin Hydrochloride And Empagliflozin Extended Release Tablets | 5 | 2 | 12 |
| 2 | Rosuvastatin Calcium and Ezetimibe Tablets (I) | 4 | 4 | 9 |
| 3 | Vonoprazan Fumarate Tablets | 4 | 3 | 60 |
| 4 | Tacrolimus Ointment | 4 | 2 | 6 |
| 5 | Azilsartan Medoxomil Potassium Tablets | 4 | 2 | 35 |
| 6 | 苯磺酸左氨氯地平片 · No verified English name | 4 | 2 | 45 |
| 7 | Lidocaine and Prilocaine Cream | 3 | 2 | 24 |
| 8 | Bromfenac Sodium Eye Drops | 3 | 2 | 7 |
| 9 | 盐酸特比萘芬喷雾剂 · No verified English name | 3 | 2 | 7 |
| 10 | Mivacurium Chloride Injection | 3 | 2 | 3 |
DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.
Most new acceptances, by company
303 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized | 20 | 18 | 0 |
| 2 | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 8 | 6 | 8 |
| 3 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized | 7 | 1 | 0 |
| 4 | Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Qilu Pharmaceutical Co., Ltd. | 5 | 4 | 1 |
| 6 | Beijing Foyou Pharma CO.,LTD | 5 | 3 | 5 |
| 7 | Pfizer Europe MA EEIG | 5 | 2 | 0 |
| 8 | Nan Tong Lian Ya Pharma Co., Ltd. romanized | 5 | 2 | 5 |
| 9 | Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized | 5 | 2 | 0 |
| 10 | Jiangxi Ke Rui Pharma Co., Ltd. romanized | 5 | 2 | 3 |
DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.
Under-review list changes
Compared across this platform's snapshots of the under-review list
Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.
DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.
Class 3 and new-drug acceptances
180 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/01/09Import · Class 1 | AZD2936 · No verified English nameJXSL2500006 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/01/09Import · Class 2.2 | Tremelimumab · No verified English nameJXSL2500005 | MedImmune LLC; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/01/09Import · Class 2.2 | Tremelimumab · No verified English nameJXSL2500004 | MedImmune LLC; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/01/09Generic · Class 3 | Aztreonam For InjectionCYHS2500196 | Shaanxi Hai Hui Pharmaceuticals Technology Co., Ltd. romanized; Haikou Shi Pharmaceutical Factory Co., Ltd. romanized |
| 2025/01/09Generic · Class 3 | Aztreonam For InjectionCYHS2500195 | Shaanxi Hai Hui Pharmaceuticals Technology Co., Ltd. romanized; Haikou Shi Pharmaceutical Factory Co., Ltd. romanized |
| 2025/01/09Generic · Class 3 | 硫酸特布他林口服溶液 · No verified English nameCYHS2500186 | Bao Li Hua (Nanjing) Pharmaceutical Co., Ltd. romanized; Shanghai Mei You Pharmaceutical Co., Ltd. romanized |
| 2025/01/09Generic · Class 3 | Dihydroxyaluminum Aminoacetate, Heavy Magnesium Carbonate and Aspirin Tablets(Ⅱ)CYHS2500185 | Pu Ji Bio Technology (Tai Zhou) Co., Ltd. romanized; Le Pu Pharmaceutical Technology Co., Ltd. romanized |
| 2025/01/09Generic · Class 3 | Sodium Bicarbonate InjectionCYHS2500184 | Ta He Shi Hui Chuang Pharmaceuticals Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2025/01/09Generic · Class 3 | Sodium Bicarbonate InjectionCYHS2500183 | Ta He Shi Hui Chuang Pharmaceuticals Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2025/01/09Generic · Class 3 | Calcium Gluconate InjectionCYHS2500182 | Henan Xin Tai Pharma Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized |
| 2025/01/09Generic · Class 3 | Chloral Hydrate SuppositoriesCYHS2500180 | Shandong Da Yin Hai Yang Biopharmaceutical Co., Ltd. romanized |
| 2025/01/09Generic · Class 3 | Indobufen TabletsCYHS2500177 | Mu Bang (Beijing) Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Yong An Pharmaceutical Co., Ltd. romanized |
| 2025/01/09Generic · Class 3 | Levothyroxine Sodium Oral SolutionCYHS2500173 | Po Nuo (Tianjin) Innovation Pharmaceuticals Research Co., Ltd. romanized; Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized |
| 2025/01/09Generic · Class 3 | 氨基酸(15)腹膜透析液 · No verified English nameCYHS2500163 | Qingdao Li Teng Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Chang Zheng Fu Min Jin Shan Pharmaceutical Co., Ltd. romanized |
| 2025/01/09Generic · Class 3 | Epalrestat TabletsCYHS2500153 | Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized |
| 2025/01/09Generic · Class 3 | Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid Oral SolutionCYHS2500152 | Hefei Kang Hui Pharmaceuticals Technology Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2025/01/09Generic · Class 3 | Mesalazine Sustained-release GranulesCYHS2500150 | Ji Chuan Pharma Group Co., Ltd. romanized |
| 2025/01/09Generic · Class 3 | Bempedoic Acid TabletsCYHL2500010 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2025/01/09Generic · Class 3 | 丙酸倍氯米松吸入气雾剂 · No verified English nameCYHL2500009 | Hefei Li Cheng Pharma Co., Ltd. romanized |
| 2025/01/09Generic · Class 3 | Mannitol-S InjectionCYHL2500008 | Hunan Xian Shi Pharmaceutical Co., Ltd. romanized |
| 2025/01/09Generic · Class 3 | Ketoprofen PatchesCYHL2500006 | Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized |
| 2025/01/09New drug · Class 2.3 | 乌灵胶囊 · No verified English nameCXZL2500002 | Zhejiang Zuo Li Pharma Co., Ltd. romanized |
| 2025/01/09New drug · Class 1 | QLP2117注射液 · No verified English nameCXSL2500029 | Qilu Pharmaceutical Co., Ltd. |
| 2025/01/09New drug · Class 2.2 | QL2107注射液 · No verified English nameCXSL2500028 | Qilu Pharmaceutical Co., Ltd. |
| 2025/01/09New drug · Class 1 | JSKN016注射液 · No verified English nameCXSL2500027 | Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized |
| 2025/01/09New drug · Class 1 | 注射用SHR-9803 · No verified English nameCXSL2500026 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Shanghai Mai Jin Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/01/09New drug · Class 1 | 注射用ZL-1310 · No verified English nameCXSL2500025 | Zai Ding Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2025/01/09New drug · Class 1 | SSGJ-627注射液 · No verified English nameCXSL2500024 | San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized |
| 2025/01/09New drug · Class 1 | 注射用JS212 · No verified English nameCXSL2500023 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/01/09New drug · Class 1 | 枸橼酸伏维西利胶囊 · No verified English nameCXHS2500006 | Jin Zhou Ao Hong Pharma Co., Ltd. romanized |
150 more not listed (at most 30 rows).
DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.
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