YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 368 drug applications between 9 September 2023 and 15 September 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 74, covering 57 drug names.
2023/09/09 – 2023/09/15
- New acceptances this week
- 368
- Drugs with new generic filings (by drug name, de-duplicated)
- 57
- Accepted this week, now under review
- 0
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
368filings, 74 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 165 |
| Generic | 74 |
| New drug | 72 |
| Import re-registration | 24 |
| Import | 23 |
| Unspecified | 10 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 275 |
| Therapeutic biologic | 45 |
| TCM | 41 |
| Prophylactic biologic | 7 |
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
57 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution | 3 | 3 | 23 |
| 2 | Vortioxetine Hydrobromide Tablets | 3 | 2 | 10 |
| 3 | Lidocaine and Prilocaine Cream | 2 | 2 | 24 |
| 4 | 吸入用布地奈德混悬液 · No verified English name | 2 | 2 | 7 |
| 5 | Levocarnitine Oral Solution | 2 | 2 | 9 |
| 6 | Pentoxifylline Injection | 2 | 2 | 3 |
| 7 | 利伐沙班颗粒 · No verified English name | 2 | 1 | 2 |
| 8 | Pregabalin Oral Solution | 2 | 1 | 5 |
| 9 | Famotidine Injection | 2 | 1 | 8 |
| 10 | Oxacillin Sodium for Injection | 2 | 1 | 13 |
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
211 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | NAPP PHARMACEUTICALS LIMITED | 15 | 1 | 0 |
| 2 | Boehringer Ingelheim International GmbH | 14 | 1 | 0 |
| 3 | Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized | 13 | 9 | 2 |
| 4 | Xian Jing Xi Shuang He Pharma Co., Ltd. romanized | 9 | 2 | 0 |
| 5 | Changchun Jin Sai Pharma Co., Ltd. romanized | 8 | 3 | 0 |
| 6 | Shanghai Bai Te Medical Yong Pin Co., Ltd. romanized | 6 | 1 | 0 |
| 7 | Bard Pharmaceuticals Limited | 5 | 5 | 0 |
| 8 | Guangdong Xin Bao Pharma Technology Co., Ltd. romanized | 5 | 5 | 0 |
| 9 | Beijing Zhi Fei Lv Zhu Biopharmaceutical Co., Ltd. romanized | 5 | 3 | 0 |
| 10 | Shenzhen Shi Tian Dao Pharmaceuticals Co., Ltd. romanized | 5 | 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
125 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/09/15Import · Class 1 | SAR442168 · No verified English nameJXHL2300224 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2023/09/15Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2302491 | Hai Men Pu Shi Pharmaceuticals Co., Ltd. romanized |
| 2023/09/15Generic · Class 3 | Dexketoprofen Trometamol InjectionCYHL2300118 | Zhong Run Pharma Co., Ltd. romanized |
| 2023/09/15Generic · Class 3 | Arformoterol Tartrate Inhalation SolutionCYHL2300117 | Jiangsu He Chen Pharma Co., Ltd. romanized |
| 2023/09/15New drug · Class 2.3 | 菖麻熄风片 · No verified English nameCXZL2300061 | Heilongjiang Sheng Ji Ren Pharma Co., Ltd. romanized |
| 2023/09/15New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSL2300626 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/09/15New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSL2300625 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/09/15New drug · Class 1 | C-13-60细胞制剂 · No verified English nameCXSL2300624 | Chongqing Jing Zhun Bio Technology Co., Ltd. romanized |
| 2023/09/15New drug · Class 1 | 注射用重组WNV-HCD86 · No verified English nameCXSL2300623 | Sichuan An Ke Kang Biopharmaceuticals Co., Ltd. romanized |
| 2023/09/15New drug · Class 1 | 注射用重组WNV-HCD86 · No verified English nameCXSL2300622 | Sichuan An Ke Kang Biopharmaceuticals Co., Ltd. romanized |
| 2023/09/15New drug · Class 1 | 注射用重组WNV-HCD86 · No verified English nameCXSL2300621 | Sichuan An Ke Kang Biopharmaceuticals Co., Ltd. romanized |
| 2023/09/15New drug · Class 1 | MC-1-50细胞制剂 · No verified English nameCXSL2300620 | Chongqing Jing Zhun Bio Technology Co., Ltd. romanized |
| 2023/09/15New drug · Class 1 | BGT-004胶囊 · No verified English nameCXHL2301006 | Bo Ji Yuan (Shanghai) Biopharmaceuticals Co., Ltd. romanized |
| 2023/09/15New drug · Class 1 | BGT-004胶囊 · No verified English nameCXHL2301005 | Bo Ji Yuan (Shanghai) Biopharmaceuticals Co., Ltd. romanized |
| 2023/09/15New drug · Class 2.2; 2.4 | 依达拉奉右莰醇舌下片 · No verified English nameCXHL2301004 | Xian Sheng Pharma Co., Ltd. romanized |
| 2023/09/15New drug · Class 1 | MN-08片 · No verified English nameCXHL2301003 | Guangzhou Xi Que Pharmaceuticals Co., Ltd. romanized |
| 2023/09/14Generic · Class 3 | Zoledronic Acid InjectionCYHS2302489 | Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized |
| 2023/09/14Generic · Class 3 | Isosorbide Oral SolutionCYHL2300116 | Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized |
| 2023/09/14New drug · Class 2.2 | 聚乙二醇重组人生长激素注射液 · No verified English nameCXSS2300076 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2023/09/14New drug · Class 1 | AK2017注射液 · No verified English nameCXSL2300619 | Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized |
| 2023/09/14New drug · Class 1 | 戈利昔替尼胶囊 · No verified English nameCXHS2300082 | Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized; Shanghai He Quan Pharmaceuticals Co., Ltd. romanized |
| 2023/09/14New drug · Class 1 | ICP-490片 · No verified English nameCXHL2301002 | Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/09/14New drug · Class 1 | ICP-490片 · No verified English nameCXHL2301001 | Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/09/14New drug · Class 2.2 | CZ4D吸入粉雾剂 · No verified English nameCXHL2301000 | Zhejiang Cui Ze Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/09/14New drug · Class 1 | TQB3015 片 · No verified English nameCXHL2300999 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2023/09/14New drug · Class 1 | TQB3015 片 · No verified English nameCXHL2300998 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2023/09/14New drug · Class 1 | SYH2038片 · No verified English nameCXHL2300997 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized |
| 2023/09/14New drug · Class 1 | SYH2038片 · No verified English nameCXHL2300996 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized |
| 2023/09/13Generic · Class 3 | 利伐沙班颗粒 · No verified English nameCYHS2302484 | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2023/09/13Generic · Class 3 | 利伐沙班颗粒 · No verified English nameCYHS2302483 | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
95 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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