YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 365 drug applications between 16 September 2023 and 22 September 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 82, covering 67 drug names.
2023/09/16 – 2023/09/22
- New acceptances this week
- 365
- Drugs with new generic filings (by drug name, de-duplicated)
- 67
- Accepted this week, now under review
- 4
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
365filings, 82 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 200 |
| Generic | 82 |
| New drug | 44 |
| Import | 28 |
| Unspecified | 7 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 259 |
| TCM | 72 |
| Therapeutic biologic | 27 |
| Prophylactic biologic | 5 |
| 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
67 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Tapentadol Hydrochloride Tablets | 3 | 1 | 0 |
| 2 | Sodium Valproate Sustained-release Tablets(I) | 2 | 2 | 4 |
| 3 | Diprophylline Injection | 2 | 2 | 7 |
| 4 | Methocarbamol Injection | 2 | 2 | 3 |
| 5 | Tacrolimus Ointment | 2 | 1 | 6 |
| 6 | Celecoxib Tablets | 2 | 1 | 3 |
| 7 | Oxcarbazepine Tablets | 2 | 1 | 4 |
| 8 | Omeprazole and Sodium Bicarbonate Capsules | 2 | 1 | 0 |
| 9 | Sacubitril Valsartan Sodium Tablets | 2 | 1 | 70 |
| 10 | Famotidine Injection | 2 | 1 | 8 |
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
206 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Boehringer Ingelheim International GmbH | 13 | 1 | 0 |
| 2 | Henan Yue Ren Pharma Co., Ltd. romanized | 12 | 12 | 0 |
| 3 | Henan Shuang He Hua Li Pharma Co., Ltd. romanized | 12 | 3 | 0 |
| 4 | Hebei Wan Bang Fu Lin Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 5 | Shanxi Huang He Zhong Yao Co., Ltd. romanized | 5 | 4 | 0 |
| 6 | Jiangxi Shimei Pharmaceutical Co., Ltd | 5 | 4 | 4 |
| 7 | HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. | 5 | 2 | 0 |
| 8 | Shaanxi Li Cai Pharma Co., Ltd. romanized | 5 | 2 | 2 |
| 9 | Bard Pharmaceuticals Limited | 4 | 4 | 0 |
| 10 | Novartis Europharm Limited | 4 | 2 | 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
97 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/09/22Import · Class 1 | BI 456906 注射液 · No verified English nameJXHL2300244 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/09/22Import · Class 1 | BI 456906 注射液 · No verified English nameJXHL2300243 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/09/22Import · Class 1 | BI 456906 注射液 · No verified English nameJXHL2300242 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/09/22Import · Class 1 | BI 456906 注射液 · No verified English nameJXHL2300241 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/09/22Import · Class 1 | BI 456906 注射液 · No verified English nameJXHL2300240 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/09/22Import · Class 1 | BI 456906 注射液 · No verified English nameJXHL2300239 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/09/22Import · Class 1 | CFT8919片 · No verified English nameJXHL2300238 | C4 Therapeutics Inc.; Betta Pharmaceuticals Co. Ltd. |
| 2023/09/22Import · Class 1 | CFT8919片 · No verified English nameJXHL2300237 | C4 Therapeutics Inc.; Betta Pharmaceuticals Co. Ltd. |
| 2023/09/22Generic · Class 3 | Tapentadol Hydrochloride TabletsCYHS2302569 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2023/09/22Generic · Class 3 | Tapentadol Hydrochloride TabletsCYHS2302568 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2023/09/22Generic · Class 3 | Tapentadol Hydrochloride TabletsCYHS2302567 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2023/09/22Generic · Class 3 | 盐酸拉贝洛尔氯化钠注射液 · No verified English nameCYHS2302560 | Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized; Chi Feng Yuan Sheng Pharma Co., Ltd. romanized |
| 2023/09/22Generic · Class 3 | Methocarbamol InjectionCYHS2302559 | Suzhou Te Rui Pharma Co., Ltd. romanized; Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized |
| 2023/09/22New drug · Class 2.3 | 保妇康栓 · No verified English nameCXZL2300063 | Hainan Bi Kai Pharma Co., Ltd. romanized |
| 2023/09/22New drug · Class 1 | WST04制剂(胶囊) · No verified English nameCXSL2300644 | Shanghai Shang Yao Xin Yi Pharmaceutical Factory Co., Ltd. romanized |
| 2023/09/22New drug · Class 1 | IBR733细胞注射液 · No verified English nameCXSL2300643 | Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized |
| 2023/09/22New drug · Class 1 | HD003细胞 · No verified English nameCXSL2300642 | Hua Dao (Shanghai) Biopharmaceuticals Co., Ltd. romanized |
| 2023/09/22New drug · Class 3.4 | 人凝血酶原复合物 · No verified English nameCXSL2300641 | Guo Yao Group Guizhou Xue Ye Zhi Pin Co., Ltd. romanized |
| 2023/09/22New drug · Class 2.2 | 盐酸多奈哌齐口溶膜 · No verified English nameCXHS2300084 | Li Pin Pharma (Xiamen) Co., Ltd. romanized; Xiamen Li Zhuo Pharma Co., Ltd. romanized |
| 2023/09/22New drug · Class 2.2 | 盐酸多奈哌齐口溶膜 · No verified English nameCXHS2300083 | Li Pin Pharma (Xiamen) Co., Ltd. romanized; Xiamen Li Zhuo Pharma Co., Ltd. romanized |
| 2023/09/22New drug · Class 1 | 177Lu-LNC1004注射液 · No verified English nameCXHL2301027 | Yan Tai Lan Na Cheng Bio Technology Co., Ltd. romanized |
| 2023/09/22New drug · Class 1 | SHR0302缓释片 · No verified English nameCXHL2301026 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2023/09/22New drug · Class 1 | SHR0302缓释片 · No verified English nameCXHL2301025 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2023/09/22New drug · Class 2.2; 2.4 | TAP-1502喷雾剂 · No verified English nameCXHL2301024 | Shanghai Ze De Man Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/09/21Import · Class 2.4 | Osimertinib Mesylate TabletsJXHS2300087 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2023/09/21Import · Class 2.4 | Osimertinib Mesylate TabletsJXHS2300086 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2023/09/21Generic · Class 3 | 草酸艾司西酞普兰口服溶液 · No verified English nameCYHS2302553 | Beijing Hai Bu Pharmaceuticals Technology Co., Ltd. romanized; Tian Da Pharma (Zhuhai) Co., Ltd. romanized |
| 2023/09/21Generic · Class 3 | Methocarbamol InjectionCYHS2302547 | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. |
| 2023/09/21Generic · Class 3 | Epalrestat TabletsCYHS2302544 | Zhongshan Wanhan Pharmaceuticals Co., Ltd. |
| 2023/09/21Generic · Class 3 | 生理氯化钠溶液 · No verified English nameCYHS2302543 | Shandong Ke Lun Pharma Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd. |
67 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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