YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 301 drug applications between 23 May 2025 and 29 May 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 77, covering 54 drug names.
2025/05/23 – 2025/05/29
- New acceptances this week
- 301
- Drugs with new generic filings (by drug name, de-duplicated)
- 54
- Accepted this week, now under review
- 40
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
301filings, 77 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 149 |
| Generic | 77 |
| New drug | 51 |
| Import | 10 |
| Unspecified | 7 |
| Import re-registration | 6 |
| Drug-device combination | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 194 |
| TCM | 50 |
| Therapeutic biologic | 45 |
| Prophylactic biologic | 8 |
| Biologic | 4 |
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
54 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Adapalene And Benzoyl Peroxide Gel | 6 | 3 | 30 |
| 2 | Acetylcysteine Injection | 4 | 4 | 53 |
| 3 | Brexpiprazole Tablets | 4 | 2 | 31 |
| 4 | Dapagliflozin Tablets | 4 | 2 | 84 |
| 5 | Brexpiprazole Orally Disintegrating Tablets | 3 | 1 | 10 |
| 6 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 7 | Aspirin Enteric-coated Tablets | 2 | 2 | 10 |
| 8 | 利伐沙班口崩片 · No verified English name | 2 | 1 | 4 |
| 9 | Levothyroxine Sodium Tablets | 2 | 1 | 12 |
| 10 | Levobupivacaine Hydrochloride Injection | 2 | 1 | 2 |
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
192 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shaanxi Pan Long Pharma Group Co., Ltd. romanized | 9 | 9 | 0 |
| 2 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 6 | 3 | 0 |
| 3 | Hangzhou He Kang Pharma Co., Ltd. romanized | 6 | 2 | 6 |
| 4 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized | 6 | 1 | 0 |
| 5 | Guangdong Sunho Pharmaceutical Co., Ltd. | 5 | 2 | 0 |
| 6 | Jilin Sheng Qi Ke Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | Haerbin Tong Yi Tang Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Guizhou Sheng Shi Long Fang Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | CSPC OUYI PHARMACEUTICAL CO., LTD. | 4 | 2 | 0 |
| 10 | UCB Pharma S.A. | 4 | 1 | 0 |
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
80 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/05/29Import · Class 1 | Giredestrant · No verified English nameJXHL2500122 | Genentech Inc.; Roche (China) Holding Ltd. |
| 2025/05/29Generic · Class 3 | Ketotifen Fumarate Oral SolutionCYHS2501921 | Anhui Mao Kang Pharma Co., Ltd. romanized; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized |
| 2025/05/29Generic · Class 3 | 中性腹膜透析液(碳酸氢盐-G4.25%) · No verified English nameCYHS2501913 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2025/05/29Generic · Class 3 | Deoxycholic Acid InjectionCYHL2500099 | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized |
| 2025/05/29New drug · Class 1.2 | JMZ-2102胶囊 · No verified English nameCXZL2500034 | Jiangxi Ji Min Ke Xin Pharma Co., Ltd. romanized |
| 2025/05/29New drug · Class 1.2 | JMZ-2102 · No verified English nameCXZL2500033 | Jiangxi Ji Min Ke Xin Pharma Co., Ltd. romanized |
| 2025/05/29New drug · Class 1.1 | 健脾疏肝固本颗粒 · No verified English nameCXZL2500032 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized |
| 2025/05/29New drug · Class 1 | 注射用YL201 · No verified English nameCXSL2500436 | Suzhou Yi Lian Biopharmaceuticals Co., Ltd. romanized |
| 2025/05/29New drug · Class 1 | IBI363 · No verified English nameCXSL2500435 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2025/05/29New drug · Class 1 | IBI363 · No verified English nameCXSL2500434 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2025/05/29New drug · Class 1 | 注射用MHB088C · No verified English nameCXSL2500433 | Ming Hui Pharmaceuticals (Hangzhou) Co., Ltd. romanized |
| 2025/05/29New drug · Class 1 | 注射用MHB039A · No verified English nameCXSL2500432 | Ming Hui Pharmaceuticals (Hangzhou) Co., Ltd. romanized |
| 2025/05/29New drug · Class 1 | 注射用HB0043 · No verified English nameCXSL2500431 | Shanghai Hua Ao Tai Bio Pharma Co., Ltd. romanized; Hua Bo Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2025/05/29New drug · Class 1.1 | 鼻喷重组呼吸道合胞病毒疫苗(5型副流感病毒载体) · No verified English nameCXSL2500430 | Guangzhou Si An Xin Bio Technology Co., Ltd. romanized |
| 2025/05/29New drug · Class 1.2 | 重组呼吸道合胞病毒疫苗(CHO细胞)(佐剂) · No verified English nameCXSL2500429 | Jiangsu Zhong Hui Yuan Tong Bio Technology Co., Ltd. romanized; Yi Hui Bio Technology (Shanghai) Co., Ltd. romanized |
| 2025/05/29New drug · Class 1 | RO7840734 · No verified English nameCXHL2500519 | Luo Shi (Zhongguo) Investment Co., Ltd. romanized |
| 2025/05/29New drug · Class 1 | RO7840734 · No verified English nameCXHL2500518 | Luo Shi (Zhongguo) Investment Co., Ltd. romanized |
| 2025/05/29New drug · Class 2.2 | 硫酸阿托品滴眼液 · No verified English nameCXHL2500517 | Hunan Mai Ou Medical Technology Co., Ltd. romanized |
| 2025/05/29New drug · Class 2.2 | 硫酸阿托品滴眼液 · No verified English nameCXHL2500516 | Hunan Mai Ou Medical Technology Co., Ltd. romanized |
| 2025/05/29New drug · Class 2.2 | KEM2417缓释干混悬剂 · No verified English nameCXHL2500515 | Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized |
| 2025/05/29New drug · Class 2.2 | KEM2417缓释干混悬剂 · No verified English nameCXHL2500514 | Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized |
| 2025/05/28Import · Class 2.2 | 注射用维泊妥珠单抗 · No verified English nameJXSS2500069 | Roche Pharma (Schweiz) AG; F. Hoffmann-La Roche AG; Roche (China) Holding Ltd. |
| 2025/05/28Import · Class 2.2 | 注射用维泊妥珠单抗 · No verified English nameJXSS2500068 | Roche Pharma (Schweiz) AG; BSP Pharmaceuticals S.p.A.; Roche (China) Holding Ltd. |
| 2025/05/28Import · Class 3.1 | 比奇珠单抗注射液 · No verified English nameJXSS2500067 | UCB Pharma S.A.; Vetter Pharma- Fertigung GmbH & Co. KG; UCB Trading (Shanghai) Co. Ltd |
| 2025/05/28Import · Class 3.1 | 比奇珠单抗注射液 · No verified English nameJXSS2500066 | UCB Pharma S.A.; Vetter Pharma-Fertigung GmbH & Co. KG; UCB Trading (Shanghai) Co. Ltd |
| 2025/05/28Generic · Class 3 | Amisulpride Oral SolutionCYHS2501908 | Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized |
| 2025/05/28Generic · Class 3 | 注射用盐酸头孢替安/氯化钠注射液 · No verified English nameCYHS2501904 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2025/05/28Generic · Class 3 | Ondansetron Hydrochloride TabletsCYHS2501901 | Nanjing Hai Jing Pharma Co., Ltd. romanized |
| 2025/05/28Generic · Class 3 | Ondansetron Hydrochloride TabletsCYHS2501900 | Nanjing Hai Jing Pharma Co., Ltd. romanized |
| 2025/05/28Generic · Class 3 | Propranolol Hydrochloride InjectionCYHS2501895 | Anhui Mei Lai Pharma Co., Ltd. romanized; Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanized |
50 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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