YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 458 drug applications between 2 September 2026 and 8 September 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 66, covering 53 drug names.
2026/09/02 – 2026/09/08
- New acceptances this week
- 458
- Drugs with new generic filings (by drug name, de-duplicated)
- 53
- Accepted this week, now under review
- 378
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
458filings, 66 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 261 |
| New drug | 85 |
| Generic | 66 |
| Import | 29 |
| Import re-registration | 13 |
| Unspecified | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 202 |
| TCM | 163 |
| Therapeutic biologic | 90 |
| Prophylactic biologic | 2 |
| In vitro diagnostic reagent | 1 |
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
53 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Adapalene And Benzoyl Peroxide Gel | 3 | 2 | 30 |
| 2 | 富马酸奥赛利定注射液 · No verified English name | 3 | 1 | 3 |
| 3 | Lactulose Oral Solution | 2 | 1 | 34 |
| 4 | Dotinurad Tablets | 2 | 1 | 55 |
| 5 | Ticagrelor Tablets | 2 | 1 | 10 |
| 6 | Rosuvastatin Calcium Tablets | 2 | 1 | 18 |
| 7 | Trazodone Hydrochloride Sustained-release Tablets | 2 | 1 | 20 |
| 8 | Fexofenadine Hydrochloride Tablets | 2 | 1 | 10 |
| 9 | Sodium Bicarbonate Injection | 2 | 1 | 10 |
| 10 | Minoxidil Liniment | 2 | 1 | 52 |
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
267 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Tai Ji Group Chongqing Tong Jun Ge Pharmaceutical Factory Co., Ltd. romanized | 13 | 13 | 0 |
| 2 | Changchun Jin Sai Pharma Co., Ltd. romanized | 8 | 2 | 0 |
| 3 | AbbVie Inc. | 8 | 1 | 0 |
| 4 | Beijing Kang Nuo Ya Biopharmaceuticals Co., Ltd. romanized | 8 | 1 | 0 |
| 5 | Gan Li Pharma Shandong Co., Ltd. romanized | 8 | 1 | 0 |
| 6 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 6 | 2 | 0 |
| 7 | Beijing Kang Di Ni Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 8 | Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized | 5 | 4 | 0 |
| 9 | Pfizer Inc. | 5 | 3 | 0 |
| 10 | Novartis Pharma AG | 4 | 4 | 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
140 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/09/08Import · Class 1 | BH-30643片 · No verified English nameJXHL2600399 | BlossomHill Therapeutics Inc.; Caidya Biopharmaceutical Co. Ltd. |
| 2026/09/08Import · Class 1 | BH-30643片 · No verified English nameJXHL2600398 | BlossomHill Therapeutics Inc.; Caidya Biopharmaceutical Co. Ltd. |
| 2026/09/08Generic · Class 3 | 坎地沙坦酯氢氯噻嗪片(Ⅰ) · No verified English nameCYHS2602244 | Anhui Jia He Pharma Co., Ltd. romanized |
| 2026/09/08Generic · Class 3 | Candesartan Cilexetil and Hydrochlorothiazide Tablets(II)CYHS2602243 | Anhui Jia He Pharma Co., Ltd. romanized |
| 2026/09/08Generic · Class 3 | 富马酸奥赛利定注射液 · No verified English nameCYHS2602242 | Chengdu Easton Biopharmaceuticals Co.,Ltd. |
| 2026/09/08Generic · Class 3 | 富马酸奥赛利定注射液 · No verified English nameCYHS2602241 | Chengdu Easton Biopharmaceuticals Co.,Ltd. |
| 2026/09/08Generic · Class 3 | 富马酸奥赛利定注射液 · No verified English nameCYHS2602240 | Chengdu Easton Biopharmaceuticals Co.,Ltd. |
| 2026/09/08Generic · Class 3 | 腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2602238 | Anhui Feng Yuan Pharma Co., Ltd. romanized |
| 2026/09/08Generic · Class 3 | 腹膜透析液(碳酸氢盐-G1.5%) · No verified English nameCYHS2602237 | Anhui Feng Yuan Pharma Co., Ltd. romanized |
| 2026/09/08Generic · Class 3 | Sodium Bicarbonate InjectionCYHS2602234 | Jiao Zuo Shi Min Kang Pharma Co., Ltd. romanized |
| 2026/09/08Generic · Class 3 | Sodium Bicarbonate InjectionCYHS2602233 | Jiao Zuo Shi Min Kang Pharma Co., Ltd. romanized |
| 2026/09/08New drug · Class 1.1 | 开心散加味颗粒 · No verified English nameCXZL2600089 | Qingdao Yi Sheng Kang He Bio Technology Co., Ltd. romanized |
| 2026/09/08New drug · Class 1.2 | YN17 · No verified English nameCXZL2600088 | Zhejiang Yong Ning Pharma Co., Ltd. romanized |
| 2026/09/08New drug · Class 1.2 | 注射用YN17 · No verified English nameCXZL2600087 | Zhejiang Yong Ning Pharma Co., Ltd. romanized |
| 2026/09/08New drug · Class 1 | SYS6088注射液 · No verified English nameCXSL2600977 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2026/09/08New drug · Class 1 | SENL103自体T细胞注射液 · No verified English nameCXSL2600976 | Hebei Sen Lang Bio Technology Co., Ltd. romanized |
| 2026/09/08New drug · Class 1 | SENL103自体T细胞注射液 · No verified English nameCXSL2600975 | Hebei Sen Lang Bio Technology Co., Ltd. romanized |
| 2026/09/08New drug · Class 1 | 注射用IMD1005 · No verified English nameCXSL2600974 | Shanghai Ying Mai De Medical Technology Co., Ltd. romanized |
| 2026/09/08New drug · Class 1 | SHR-4375注射液 · No verified English nameCXSL2600973 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2026/09/08New drug · Class 1 | JV101注射液 · No verified English nameCXSL2600972 | Shanghai Yu Fang Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/09/08New drug · Class 1 | HDM4002注射液 · No verified English nameCXSL2600971 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized |
| 2026/09/08New drug · Class 1 | 注射用SIM0505 · No verified English nameCXSL2600970 | Shanghai Xian Sheng Zai Ming Pharmaceuticals Bio Technology Co., Ltd. romanized |
| 2026/09/08New drug · Class 2.2 | 阿得贝利单抗注射液 · No verified English nameCXSL2600969 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2026/09/08New drug · Class 1 | SHR-4610注射液 · No verified English nameCXSL2600968 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2026/09/08New drug · Class 2.2 | 罗赛促红素α注射液 · No verified English nameCXSL2600967 | Guangdong San Sheng Pharmaceutical Co., Ltd. romanized |
| 2026/09/08New drug · Class 2.4 | 泽布替尼胶囊 · No verified English nameCXHS2600127 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2026/09/08New drug · Class 1 | HX9428片 · No verified English nameCXHL2601091 | Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanized |
| 2026/09/08New drug · Class 1 | HX9428片 · No verified English nameCXHL2601090 | Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanized |
| 2026/09/08New drug · Class 1 | TAN-118乳膏 · No verified English nameCXHL2601089 | Shanghai Ze De Man Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/09/08New drug · Class 1 | TAN-118乳膏 · No verified English nameCXHL2601088 | Shanghai Ze De Man Pharmaceuticals Technology Co., Ltd. romanized |
110 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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