YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 320 drug applications between 12 January 2023 and 18 January 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 76, covering 59 drug names.
2023/01/12 – 2023/01/18
- New acceptances this week
- 320
- Drugs with new generic filings (by drug name, de-duplicated)
- 59
- Accepted this week, now under review
- 1
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
320filings, 76 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 145 |
| Generic | 76 |
| New drug | 57 |
| Import | 18 |
| Import re-registration | 14 |
| Unspecified | 10 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 226 |
| TCM | 47 |
| Therapeutic biologic | 42 |
| Prophylactic biologic | 4 |
| Biologic | 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
59 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Nifedipine Controlled-release Tablets | 3 | 1 | 7 |
| 2 | Diquafosol Sodium Eye Drops | 2 | 2 | 5 |
| 3 | Ganirelix Injection | 2 | 2 | 1 |
| 4 | Clindamycin Injection | 2 | 1 | 4 |
| 5 | Perindopril and Indapamide Tablets | 2 | 1 | 3 |
| 6 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 7 | Ibuprofen Injection | 2 | 1 | 8 |
| 8 | Lafutidine Tablets | 2 | 1 | 2 |
| 9 | Piperacillin Sodium for Injection | 2 | 1 | 16 |
| 10 | Desvenlafaxine Extended-release Tablets | 2 | 1 | 0 |
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
201 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Ping Guang Pharmaceutical Co., Ltd. romanized | 18 | 18 | 0 |
| 2 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 7 | 3 | 0 |
| 3 | Sichuan Pharmaceutical Formulations Co., Ltd. romanized | 6 | 1 | 0 |
| 4 | Shandong Run Ze Pharmaceutical Co., Ltd. romanized | 6 | 1 | 0 |
| 5 | An Yang Guang Sheng Heng Pharmaceutical Co., Ltd. romanized | 5 | 4 | 0 |
| 6 | Qilu Pharmaceutical Co., Ltd. | 4 | 4 | 3 |
| 7 | Guo Yao Group Guo Rui Pharma Co., Ltd. romanized | 4 | 2 | 2 |
| 8 | Ji Chuan Pharma Group Co., Ltd. romanized | 4 | 2 | 2 |
| 9 | Zhuhai Lian Bang Pharmaceutical Co., Ltd. romanized | 4 | 2 | 0 |
| 10 | Sanofi-aventis groupe | 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
94 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/01/18Import · Class 3.1 | 利妥昔单抗注射液(皮下注射) · No verified English nameJXSS2300012 | Roche Pharma (Schweiz) AG; F. Hoffmann-La Roche AG |
| 2023/01/18Import · Class 3.1 | 帕博利珠单抗注射液 · No verified English nameJXSS2300011 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd |
| 2023/01/18Import · Class 2.2; 2.4 | 丙酸氯倍他索纳米混悬滴眼液 · No verified English nameJXHL2300009 | Formosa Pharmaceuticals Inc.; Grandpharma (China) Co. Ltd. |
| 2023/01/18New drug · Class 1 | QLP2117注射液 · No verified English nameCXSL2300050 | Qilu Pharmaceutical Co., Ltd. |
| 2023/01/18New drug · Class 1 | 重组抗IL-4Rα人源化单克隆抗体注射液 · No verified English nameCXSL2300049 | San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized |
| 2023/01/18New drug · Class 2.2 | 注射用维迪西妥单抗 · No verified English nameCXSL2300048 | Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized |
| 2023/01/18New drug · Class 1 | 注射用FZ-AD004抗体偶联剂 · No verified English nameCXSL2300047 | Shanghai Fu Dan Zhang Jiang Biopharmaceuticals Co., Ltd. romanized |
| 2023/01/18New drug · Class 1 | FCN-338片 · No verified English nameCXHL2300094 | Chongqing Fu Chuang Pharmaceuticals Research Co., Ltd. romanized |
| 2023/01/18New drug · Class 1 | FCN-338片 · No verified English nameCXHL2300093 | Chongqing Fu Chuang Pharmaceuticals Research Co., Ltd. romanized |
| 2023/01/18New drug · Class 1 | FCN-289片 · No verified English nameCXHL2300092 | Chongqing Fu Shang Yuan Chuang Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/01/18New drug · Class 1 | FCN-289片 · No verified English nameCXHL2300091 | Chongqing Fu Shang Yuan Chuang Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/01/18New drug · Class 1 | SK-07注射液 · No verified English nameCXHL2300090 | Guangzhou Kang Chen Pharma Co., Ltd. romanized |
| 2023/01/18New drug · Class 1 | SK-07注射液 · No verified English nameCXHL2300089 | Guangzhou Kang Chen Pharma Co., Ltd. romanized |
| 2023/01/18New drug · Class 2.1; 2.2; 2.4 | HW-N2001注射液 · No verified English nameCXHL2300088 | Shandong Dao He Pharma Co., Ltd. romanized; Wei Fang Yi College romanized |
| 2023/01/17Import · Class 2.2 | 司库奇尤单抗注射液 · No verified English nameJXSL2300025 | Novartis Pharma Schweiz AG; Beijing Novartis Pharma Co. Ltd. |
| 2023/01/17Generic · Class 3 | Emtricitabine, Rilpivirine, and Tenofovir Alafenamide TabletsCYHS2300165 | Qilu Pharmaceutical Co., Ltd. |
| 2023/01/17Generic · Class 3 | Ibuprofen InjectionCYHS2300163 | Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized |
| 2023/01/17Generic · Class 3 | Ibuprofen InjectionCYHS2300162 | Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized |
| 2023/01/17Generic · Class 3 | Fosaprepitant Dimeglumine for InjectionCYHS2300157 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2023/01/17Generic · Class 3 | Pentoxifylline InjectionCYHS2300156 | Shandong Qidu Pharmaceutical Co., Ltd. |
| 2023/01/17Generic · Class 3 | Lafutidine TabletsCYHS2300155 | Ji Chuan Pharma Group Co., Ltd. romanized |
| 2023/01/17Generic · Class 3 | Lafutidine TabletsCYHS2300154 | Ji Chuan Pharma Group Co., Ltd. romanized |
| 2023/01/17Generic · Class 3 | 生理氯化钠溶液 · No verified English nameCYHS2300148 | Jilin Sheng Dou Bang Pharma Co., Ltd. romanized |
| 2023/01/17Generic · Class 3 | Dienogest TabletsCYHL2300007 | Shanghai Hui Lun Pharmaceuticals Co., Ltd. romanized |
| 2023/01/17New drug · Class 1.1 | 异功散颗粒 · No verified English nameCXZL2300002 | Shen Wei Pharma Group Co., Ltd. romanized |
| 2023/01/17New drug · Class 1 | 重组人内皮抑素腺病毒注射液 · No verified English nameCXSL2300046 | Guangzhou Da Bo Bio Zhi Pin Co., Ltd. romanized |
| 2023/01/17New drug · Class 1 | 注射用SHR-9839 · No verified English nameCXSL2300044 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2023/01/17New drug · Class 1 | 注射用BC3195 · No verified English nameCXSL2300043 | Wuxi Zhi Kang Hong Yi Bio Technology Co., Ltd. romanized |
| 2023/01/17New drug · Class 2.2 | 替雷利珠单抗注射液 · No verified English nameCXSL2300042 | Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized |
| 2023/01/17New drug · Class 1 | IMC002注射液 · No verified English nameCXSL2300041 | Suzhou Yi Mu Feng Bio Technology Co., Ltd. romanized |
64 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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