YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 374 drug applications between 25 January 2022 and 31 January 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 95, covering 60 drug names.
2022/01/25 – 2022/01/31
- New acceptances this week
- 374
- Drugs with new generic filings (by drug name, de-duplicated)
- 60
- 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
374filings, 95 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 175 |
| Generic | 95 |
| New drug | 66 |
| Import | 24 |
| Unspecified | 7 |
| Import re-registration | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 268 |
| Therapeutic biologic | 64 |
| TCM | 36 |
| Prophylactic biologic | 5 |
| 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
60 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Tadalafil Tablets | 5 | 3 | 23 |
| 2 | 氧(液态) · No verified English name | 4 | 4 | 13 |
| 3 | 氧 · No verified English name | 3 | 3 | 15 |
| 4 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution | 3 | 2 | 23 |
| 5 | Oseltamivir Phosphate For Oral Suspension | 3 | 2 | 2 |
| 6 | Oliceridine Fumarate Injection | 3 | 1 | 0 |
| 7 | Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation | 3 | 1 | 12 |
| 8 | Lurasidone Hydrochloride Tablets | 3 | 1 | 2 |
| 9 | Folic Acid Tablets | 2 | 2 | 12 |
| 10 | Argatroban 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
214 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Guangxi Di Tai Pharmaceutical Co., Ltd. romanized | 15 | 13 | 0 |
| 2 | Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized | 13 | 6 | 0 |
| 3 | Hubei Rui Ze Pharma Co., Ltd. romanized | 9 | 9 | 0 |
| 4 | N.V. Organon | 8 | 1 | 0 |
| 5 | Qilu Pharmaceutical Co., Ltd. | 7 | 5 | 0 |
| 6 | Octapharma AB | 7 | 1 | 0 |
| 7 | Chengdu Brilliant Pharmaceutical Co., Ltd. | 6 | 3 | 1 |
| 8 | Qilu Pharmaceutical (Hainan) Co., Ltd | 6 | 3 | 6 |
| 9 | Zhengzhou Zhuo Feng Pharmaceutical Co., Ltd. romanized | 5 | 4 | 0 |
| 10 | Janssen Research & Development LLC | 5 | 3 | 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
113 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/01/30Import · Class 1 | JNJ-75348780 注射液 · No verified English nameJXSL2200017 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/01/30Import · Class 1 | JNJ-75348780 注射液 · No verified English nameJXSL2200016 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/01/30Generic · Class 3 | 二氟泼尼酯滴眼液 · No verified English nameCYHS2200260 | Tianjin Jin Yao Pharma Co., Ltd. romanized |
| 2022/01/30Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2200253 | Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized; Beijing Hua Run Gao Ke Tian Ran Drug Co., Ltd. romanized |
| 2022/01/30New drug · Class 1 | 注射用TQB2930 · No verified English nameCXSL2200067 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2022/01/30New drug · Class 1.3 | 冻干人用CpG佐剂狂犬病疫苗(Vero细胞) · No verified English nameCXSL2200066 | Changchun Zhuo Yi Bio Co., Ltd. romanized |
| 2022/01/30New drug · Class 1 | 注射用DB-1303 · No verified English nameCXSL2200065 | Ying En Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2022/01/30New drug · Class 1 | IMS001注射液 · No verified English nameCXSL2200064 | Zhuhai Heng Qin Ai Mu Si Tan Bio Technology Co., Ltd. romanized |
| 2022/01/30New drug · Class 1 | TST001注射液 · No verified English nameCXSL2200063 | Suzhou Chuang Sheng Pharmaceuticals Group Co., Ltd. romanized |
| 2022/01/30New drug · Class 1 | GT101注射液 · No verified English nameCXSL2200061 | Suzhou Sha Li Bio Technology Co., Ltd. romanized |
| 2022/01/30New drug · Class 1 | 注射用重组人源化抗CD70单抗-AS269偶联物(ARX305) · No verified English nameCXSL2101498 | Zhejiang Xin Ma Biopharmaceuticals Co., Ltd. romanized |
| 2022/01/30New drug · Class 1 | LNK01004软膏 · No verified English nameCXHL2200070 | Ling Ke Pharma (Hangzhou) Co., Ltd. romanized |
| 2022/01/30New drug · Class 1 | LNK01004软膏 · No verified English nameCXHL2200069 | Ling Ke Pharma (Hangzhou) Co., Ltd. romanized |
| 2022/01/30New drug · Class 1 | LNK01004软膏 · No verified English nameCXHL2200068 | Ling Ke Pharma (Hangzhou) Co., Ltd. romanized |
| 2022/01/30New drug · Class 1 | LNK01004软膏 · No verified English nameCXHL2200067 | Ling Ke Pharma (Hangzhou) Co., Ltd. romanized |
| 2022/01/29Import · Class 1 | Nipocalimab注射液 · No verified English nameJXSL2200015 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/01/29Import · Class 2.4 | OQL011 · No verified English nameJXHL2200033 | OnQuality Pharmaceuticals(USA)LLC; Suzhou Puhe Biopharma Co. Ltd |
| 2022/01/29Import · Class 2.4 | OQL011 · No verified English nameJXHL2200032 | OnQuality Pharmaceuticals(USA)LLC; Suzhou Puhe Biopharma Co. Ltd |
| 2022/01/29Import · Class 2.4 | OQL011 · No verified English nameJXHL2200031 | OnQuality Pharmaceuticals(USA)LLC; Suzhou Puhe Biopharma Co. Ltd |
| 2022/01/29Generic · Class 3 | Cefotaxime Sodium For InjectionCYHS2200249 | Hunan Heng Sheng Pharmaceutical Co., Ltd. romanized |
| 2022/01/29Generic · Class 3 | Cefotaxime Sodium For InjectionCYHS2200248 | Hunan Heng Sheng Pharmaceutical Co., Ltd. romanized |
| 2022/01/29Generic · Class 3 | Arbidol Hydrochloride TabletsCYHS2200238 | Wuhan Ren Fu Li Kang Pharma Co., Ltd. romanized |
| 2022/01/29Generic · Class 3 | Oseltamivir Phosphate For Oral SuspensionCYHS2200237 | Guangdong Wan Fang Pharma Technology Co., Ltd. romanized; HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. |
| 2022/01/29Generic · Class 3 | Oseltamivir Phosphate For Oral SuspensionCYHS2200236 | Guangdong Wan Fang Pharma Technology Co., Ltd. romanized; HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. |
| 2022/01/29Generic · Class 3 | Oseltamivir Phosphate For Oral SuspensionCYHS2200234 | Haerbin Hua Rui Sheng Hua Pharma Co., Ltd. romanized |
| 2022/01/29New drug · Class 1.1 | 柴金解郁安神片 · No verified English nameCXZL2200005 | Hunan Zhong Pharmaceuticals University romanized |
| 2022/01/29New drug · Class 1 | 注射用MHB008C · No verified English nameCXSL2200062 | Ming Hui Pharmaceuticals (Hangzhou) Co., Ltd. romanized |
| 2022/01/29New drug · Class 2.2 | 替雷利珠单抗注射液 · No verified English nameCXSL2200060 | Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized |
| 2022/01/29New drug · Class 1 | 欧司珀利单抗注射液 · No verified English nameCXSL2200059 | Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized |
| 2022/01/29New drug · Class 1 | TAEST1901注射液 · No verified English nameCXSL2200058 | Xiang Xue Sheng Ming Ke Xue Technology (Guangdong) Co., Ltd. romanized |
83 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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