YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 386 drug applications between 7 December 2023 and 13 December 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 80, covering 56 drug names.
2023/12/07 – 2023/12/13
- New acceptances this week
- 386
- Drugs with new generic filings (by drug name, de-duplicated)
- 56
- 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
386filings, 80 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 208 |
| Generic | 80 |
| New drug | 61 |
| Import | 28 |
| Import re-registration | 6 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 226 |
| TCM | 85 |
| Therapeutic biologic | 68 |
| Biologic | 3 |
| Prophylactic biologic | 3 |
| 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
56 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 地氯雷他定口服溶液 · No verified English name | 3 | 3 | 26 |
| 2 | Levocarnitine Oral Solution | 3 | 2 | 9 |
| 3 | Minoxidil Liniment | 3 | 2 | 52 |
| 4 | Diprophylline Injection | 2 | 2 | 7 |
| 5 | Morinidazole and Sodium Chloride Injection | 2 | 2 | 9 |
| 6 | Ceftazidime And Avibactam Sodium For Injection | 2 | 2 | 12 |
| 7 | Methocarbamol Injection | 2 | 2 | 3 |
| 8 | Agomelatine Tablets | 2 | 2 | 8 |
| 9 | Acetylcysteine Oral Solution | 2 | 1 | 11 |
| 10 | Bisoprolol Fumarate Tablets | 2 | 1 | 6 |
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 | Lan Yun Zhi He Bio Technology Co., Ltd. romanized | 43 | 34 | 0 |
| 2 | Novo Nordisk A/S | 15 | 1 | 0 |
| 3 | Tai Ji Group Sichuan Tian Cheng Pharmaceutical Co., Ltd. romanized | 8 | 8 | 0 |
| 4 | Fresenius Kabi Austria GmbH | 6 | 1 | 0 |
| 5 | Chengdu Di Ao Pharmaceutical Group Co., Ltd. romanized | 6 | 1 | 0 |
| 6 | Karuna Therapeutics Inc. | 5 | 1 | 0 |
| 7 | GlaxoSmithKline (Ireland) Limited | 4 | 3 | 0 |
| 8 | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 4 | 3 | 2 |
| 9 | F. Hoffmann-La Roche Ltd | 4 | 2 | 0 |
| 10 | Janssen Research & Development LLC | 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
124 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/12/13Import · Class 1 | CagriSema注射液 · No verified English nameJXSL2300225 | Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd |
| 2023/12/13Import · Class 1 | CagriSema注射液 · No verified English nameJXSL2300224 | Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd |
| 2023/12/13Import · Class 1 | CagriSema注射液 · No verified English nameJXSL2300223 | Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd |
| 2023/12/13Import · Class 1 | CagriSema注射液 · No verified English nameJXSL2300222 | Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd |
| 2023/12/13Import · Class 1 | CagriSema注射液 · No verified English nameJXSL2300221 | Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd |
| 2023/12/13Generic · Class 3 | Acetylcysteine Oral SolutionCYHS2303448 | Nanjing Ai De Jia Biopharmaceutical Technology Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2023/12/13Generic · Class 3 | Acetylcysteine Oral SolutionCYHS2303447 | Nanjing Ai De Jia Biopharmaceutical Technology Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2023/12/13Generic · Class 3 | Labetalol Hydrochloride InjectionCYHS2303445 | Nanjing Hai Ke Rui Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Su Zhong Pharma Group Biopharmaceutical Co., Ltd. romanized |
| 2023/12/13Generic · Class 3 | Labetalol Hydrochloride InjectionCYHS2303444 | Nanjing Hai Ke Rui Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Su Zhong Pharma Group Biopharmaceutical Co., Ltd. romanized |
| 2023/12/13New drug · Class 1 | GC012F注射液 · No verified English nameCXSL2300855 | Suzhou Gen Xi Bio Technology Co., Ltd. romanized; Gen Xi Bio Technology (Shanghai) Co., Ltd. romanized |
| 2023/12/13New drug · Class 1 | YFQLXB-UC01注射液 · No verified English nameCXSL2300854 | Shandong Sheng Qi Lu Xi Bao Zhi Liao Gong Cheng Technology Co., Ltd. romanized |
| 2023/12/13New drug · Class 2.2 | 盐酸多奈哌齐口溶膜 · No verified English nameCXHL2301386 | Shanxi Huang Cheng Xiang Fu Pharma Co., Ltd. romanized |
| 2023/12/13New drug · Class 1 | DA-302168S片 · No verified English nameCXHL2301385 | Chengdu Di Ao Pharmaceutical Group Co., Ltd. romanized |
| 2023/12/13New drug · Class 1 | DA-302168S片 · No verified English nameCXHL2301384 | Chengdu Di Ao Pharmaceutical Group Co., Ltd. romanized |
| 2023/12/13New drug · Class 1 | DA-302168S片 · No verified English nameCXHL2301383 | Chengdu Di Ao Pharmaceutical Group Co., Ltd. romanized |
| 2023/12/13New drug · Class 1 | DA-302168S片 · No verified English nameCXHL2301382 | Chengdu Di Ao Pharmaceutical Group Co., Ltd. romanized |
| 2023/12/13New drug · Class 1 | DA-302168S片 · No verified English nameCXHL2301381 | Chengdu Di Ao Pharmaceutical Group Co., Ltd. romanized |
| 2023/12/13New drug · Class 1 | DA-302168S片 · No verified English nameCXHL2301380 | Chengdu Di Ao Pharmaceutical Group Co., Ltd. romanized |
| 2023/12/12Import · Class 3.1 | 艾沙妥昔单抗注射液 · No verified English nameJXSS2300091 | Sanofi Winthrop Industrie; Sanofi-Aventis Deutschland GmbH; Sanofi (China) Investment Co. Ltd. |
| 2023/12/12Import · Class 3.1 | 艾沙妥昔单抗注射液 · No verified English nameJXSS2300090 | Sanofi Winthrop Industrie; Sanofi-Aventis Deutschland GmbH; Sanofi (China) Investment Co. Ltd. |
| 2023/12/12Import · Class 3.1 | 注射用德曲妥珠单抗 · No verified English nameJXSS2300089 | Daiichi Sankyo Europe GmbH; Baxter Oncology GmbH; DAIICHI SANKYO(CHINA)HOLDINGS CO. LTD. |
| 2023/12/12Generic · Class 3 | 注射用头孢唑林钠/氯化钠注射液 · No verified English nameCYHS2303443 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2023/12/12Generic · Class 3 | Fludeoxyglucose[18F] InjectionCYHS2303442 | Guangdong Gao Shang Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Hui Xuan Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/12/12Generic · Class 3 | 生理氯化钠溶液 · No verified English nameCYHS2303441 | Guangdong Ke Hong Pharma Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2023/12/12Generic · Class 3 | 生理氯化钠溶液 · No verified English nameCYHS2303440 | Guangdong Ke Hong Pharma Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2023/12/12Generic · Class 3 | Adenosine InjectionCYHS2303438 | Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized |
| 2023/12/12Generic · Class 3 | Adenosine InjectionCYHS2303437 | Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized |
| 2023/12/12Generic · Class 3 | Norepinephrine Bitartrate InjectionCYHS2303435 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2023/12/12Generic · Class 3 | Calcium Gluconate InjectionCYHS2303434 | Jiangxi Tai Ji Li Biopharmaceuticals Technology Co., Ltd. romanized; Jiangxi Dong Fu Pharmaceutical Co., Ltd. romanized |
| 2023/12/12Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2303428 | Shandong Jian Dao Pharmaceutical Co., Ltd. romanized |
94 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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