YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 445 drug applications between 30 December 2022 and 5 January 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 73, covering 51 drug names.
2022/12/30 – 2023/01/05
- New acceptances this week
- 445
- Drugs with new generic filings (by drug name, de-duplicated)
- 51
- 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
445filings, 73 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 279 |
| Generic | 73 |
| New drug | 66 |
| Import | 12 |
| Import re-registration | 9 |
| Unspecified | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 294 |
| TCM | 107 |
| Therapeutic biologic | 38 |
| Prophylactic biologic | 4 |
| In vitro diagnostic reagent | 1 |
| 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
51 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Clindamycin Injection | 3 | 1 | 4 |
| 2 | Remifentanil Hydrochloride for Injection | 3 | 1 | 2 |
| 3 | Penicillin G Sodium For Injection | 3 | 1 | 2 |
| 4 | Gadobutrol Injection | 3 | 1 | 8 |
| 5 | Gadoteric Acid Meglumine Salt Injection | 3 | 1 | 1 |
| 6 | Pregabalin Oral Solution | 2 | 2 | 5 |
| 7 | Famotidine Injection | 2 | 2 | 8 |
| 8 | Vildagliptin Tablets | 2 | 2 | 0 |
| 9 | Sitagliptin Phosphate and Metformin Hydrochloride Tablets (II) | 2 | 2 | 3 |
| 10 | Phloroglucinol Injection | 2 | 2 | 2 |
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
191 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Guangxi Wei Wei Pharmaceutical Co., Ltd. romanized | 44 | 44 | 0 |
| 2 | Hubei Lang De Pharma Co., Ltd. romanized | 32 | 16 | 0 |
| 3 | Guo Da (Heilongjiang) Pharmaceutical Technology Co., Ltd. romanized | 31 | 31 | 0 |
| 4 | Fresenius Kabi Deutschland GmbH | 24 | 2 | 0 |
| 5 | Jiangxi Xin Zheng Pharma Co., Ltd. romanized | 12 | 11 | 0 |
| 6 | Guangzhou Bai Te Medical Yong Pin Co., Ltd. romanized | 9 | 6 | 0 |
| 7 | Qi Yuan Bio (Hangzhou) Co., Ltd. romanized | 8 | 1 | 0 |
| 8 | Jilin Te Yan Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 9 | Nei Menggu Meng He Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized | 4 | 4 | 3 |
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
110 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/01/05Import · Class 1 | Marstacimab注射液 · No verified English nameJXSL2300008 | Pfizer Inc.; Pfizer Investment Co. Ltd. |
| 2023/01/05Import · Class 1 | Marstacimab注射液 · No verified English nameJXSL2300007 | Pfizer Inc.; Pfizer Investment Co. Ltd. |
| 2023/01/05Import · Class 1 | 重组人REIC/Dkk-3基因复制缺陷5型腺病毒注射液 · No verified English nameJXSL2300006 | Momotaro Gene Inc.; Adreic Therapeutics Inc. |
| 2023/01/05Import · Class 1 | VAY736注射液 · No verified English nameJXSL2300005 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2023/01/05Import · Class 2.4 | Empagliflozin TabletsJXHS2300001 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim Pharma GmbH & Co. KG; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/01/05Generic · Class 3 | Betamethasone Sodium Phosphate InjectionCYHS2300029 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2023/01/05Generic · Class 3 | Vigabatrin Powder for Oral SolutionCYHS2300027 | Yuan Da Pharmaceuticals (Zhongguo) Co., Ltd. romanized |
| 2023/01/05Generic · Class 3 | Aminocaproic Acid InjectionCYHS2300023 | Ningbo Zhuo Lun Pharmaceuticals Technology Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized |
| 2023/01/05Generic · Class 3 | 非洛地平片 · No verified English nameCYHS2300022 | Hunan Nuo Na Pharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd |
| 2023/01/05Generic · Class 3 | Penicillin G Sodium For InjectionCYHS2300019 | Chengdu Tian Zhi Yi Shang Pin Pharmaceuticals Technology Co., Ltd. romanized; NORTH CHINA PHARMACEUTICAL COMPANY.LTD |
| 2023/01/05Generic · Class 3 | Penicillin G Sodium For InjectionCYHS2300018 | Chengdu Tian Zhi Yi Shang Pin Pharmaceuticals Technology Co., Ltd. romanized; NORTH CHINA PHARMACEUTICAL COMPANY.LTD |
| 2023/01/05Generic · Class 3 | Penicillin G Sodium For InjectionCYHS2300017 | Chengdu Tian Zhi Yi Shang Pin Pharmaceuticals Technology Co., Ltd. romanized; NORTH CHINA PHARMACEUTICAL COMPANY.LTD |
| 2023/01/05Generic · Class 3 | Pregabalin Extended release TabletsCYHS2300016 | Shanghai Xin Yi Tian Ping Pharma Co., Ltd. romanized |
| 2023/01/05Generic · Class 3 | Brivaracetam Oral SolutionCYHL2300003 | Jiangsu Ai Li Kang Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/01/05New drug · Class 1 | VUM02注射液 · No verified English nameCXSL2300006 | Wuhan Guang Gu Zhong Yuan Pharma Co., Ltd. romanized |
| 2023/01/05New drug · Class 1 | 注射用EX105 · No verified English nameCXSL2300005 | Guangzhou Ai Si Mai Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/01/05New drug · Class 1 | 注射用LM-108 · No verified English nameCXSL2300004 | Shanghai Li Xin Pharmaceuticals Research and Development Co., Ltd. romanized |
| 2023/01/05New drug · Class 2.4 | Azithromycin For InjectionCXHS2300005 | Changchun Hai Yue Pharma Co., Ltd. romanized |
| 2023/01/05New drug · Class 2.4 | Azithromycin For InjectionCXHS2300004 | Changchun Hai Yue Pharma Co., Ltd. romanized |
| 2023/01/05New drug · Class 2.4 | Azithromycin For InjectionCXHS2300003 | Changchun Hai Yue Pharma Co., Ltd. romanized |
| 2023/01/05New drug · Class 1 | SPH4336片 · No verified English nameCXHL2300011 | Shanghai Pharmaceuticals Group Co., Ltd. romanized |
| 2023/01/05New drug · Class 1 | PA9159乳膏 · No verified English nameCXHL2300010 | Anhui Bai La A Tu Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/01/05New drug · Class 2.2 | HQ-0124片 · No verified English nameCXHL2300009 | Ze Zheng (Shanghai) Bio Technology Co., Ltd. romanized |
| 2023/01/05New drug · Class 2.2 | HQ-0124片 · No verified English nameCXHL2300008 | Ze Zheng (Shanghai) Bio Technology Co., Ltd. romanized |
| 2023/01/05New drug · Class 1 | 注射用RN-0001 · No verified English nameCXHL2300007 | Rui Nuo Medical Technology (Shanghai) Co., Ltd. romanized |
| 2023/01/04Import · Class 1 | MEDI3506注射液 · No verified English nameJXSL2300004 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/01/04Import · Class 1 | Epcoritamab注射液 · No verified English nameJXSL2300003 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2023/01/04Import · Class 1 | Epcoritamab注射用浓溶液 · No verified English nameJXSL2300002 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2023/01/04Import · Class 2.2 | Ravulizumab注射液 · No verified English nameJXSL2300001 | Alexion Pharmaceuticals Inc.; AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/01/04Generic · Class 3 | Famotidine InjectionCYHS2300014 | Beijing Bu Lin Bio Technology Co., Ltd. romanized; Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
80 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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