YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 173 drug applications between 27 July 2021 and 2 August 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 20, covering 17 drug names.
2021/07/27 – 2021/08/02
- New acceptances this week
- 173
- Drugs with new generic filings (by drug name, de-duplicated)
- 17
- 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
173filings, 20 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 83 |
| New drug | 34 |
| Import | 21 |
| Generic | 20 |
| Unspecified | 9 |
| Import re-registration | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 118 |
| Therapeutic biologic | 29 |
| TCM | 24 |
| Biologic | 2 |
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
17 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Empagliflozin Tablets | 2 | 1 | 18 |
| 2 | Pregabalin Capsules | 2 | 1 | 12 |
| 3 | Caspofungin Acetate for Injection | 2 | 1 | 8 |
| 4 | Enoxaparin Sodium Injection | 1 | 1 | 16 |
| 5 | Doxofylline Injection | 1 | 1 | 5 |
| 6 | Tenofovir alafenamide Fumarate Tablets | 1 | 1 | 0 |
| 7 | Ibuprofen Suspension | 1 | 1 | 14 |
| 8 | 布洛芬混悬滴剂 · No verified English name | 1 | 1 | 0 |
| 9 | Clofarabine Injection | 1 | 1 | 0 |
| 10 | Ambroxol Hydrochloride Oral Solution | 1 | 1 | 46 |
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
109 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Heilongjiang Lin Hai Xue Yuan Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 2 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 5 | 2 | 0 |
| 3 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 5 | 2 | 0 |
| 4 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 4 | 4 | 2 |
| 5 | Janssen-Cilag International NV | 3 | 2 | 0 |
| 6 | San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized | 3 | 2 | 0 |
| 7 | Rui Yang Pharmaceutical Co., Ltd. romanized | 3 | 2 | 0 |
| 8 | Bristol-Myers Squibb Pharma EEIG | 3 | 1 | 0 |
| 9 | Pfizer Europe MA EEIG | 3 | 1 | 0 |
| 10 | Nei Menggu Jing Xin Pharma Co., Ltd. romanized | 3 | 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
52 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/07/30Import · Class 1 | Rilzabrutinib · No verified English nameJXHL2101147 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2021/07/30Generic · Class 3 | Clofarabine InjectionCYHS2101502 | Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized |
| 2021/07/30New drug · Class 1.1 | 芪红固本颗粒 · No verified English nameCXZL2101021 | Guangzhou Ru Yuan Bio Technology Co., Ltd. romanized |
| 2021/07/30New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSS2101015 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Suzhou Zhong He Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/07/30New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSS2101014 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Suzhou Zhong He Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/07/30New drug · Class 1 | 重组抗PD-1人源化单克隆抗体注射液 · No verified English nameCXSL2101226 | San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized |
| 2021/07/30New drug · Class 1 | ELPIS人脐带间充质干细胞注射液 · No verified English nameCXSL2101224 | Hua Xia Yuan Xi Bao Gong Cheng Group Co., Ltd. romanized |
| 2021/07/30New drug · Class 2.4 | Anlotinib Hydrochloride CapsulesCXHL2101347 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2021/07/30New drug · Class 2.4 | Anlotinib Hydrochloride CapsulesCXHL2101346 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2021/07/30New drug · Class 2.4 | Anlotinib Hydrochloride CapsulesCXHL2101345 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2021/07/30New drug · Class 1 | NB005胶囊 · No verified English nameCXHL2101344 | Ningbo Xin Wan Technology Development Co., Ltd. romanized |
| 2021/07/30New drug · Class 1 | NB005胶囊 · No verified English nameCXHL2101343 | Ningbo Xin Wan Technology Development Co., Ltd. romanized |
| 2021/07/29Import · Class 1 | TJ107注射液 · No verified English nameJXSL2101083 | I-MAB Biopharma US Limited; I-MAB Biopharma Co. Ltd. |
| 2021/07/29Import · Class 1 | Bermekimab注射液 · No verified English nameJXSL2101082 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2021/07/29Import · Class 1 | DS-1062a · No verified English nameJXSL2101081 | Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD. |
| 2021/07/29Generic · Class 3 | Ambroxol Hydrochloride Oral SolutionCYHS2101495 | Hangzhou Yuan Su Pharmaceuticals Co., Ltd. romanized; Zhejiang Kai Run Pharma Co., Ltd. romanized |
| 2021/07/29Generic · Class 3 | 布洛芬混悬滴剂 · No verified English nameCYHS2101494 | Beijing Bai Ao Pharma Co., Ltd. romanized; Jilin Yi Min Tang Pharmaceutical Co., Ltd. romanized |
| 2021/07/29Generic · Class 3 | Magnesium Sulfate InjectionCYHS2101489 | Guangzhou Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2021/07/29New drug · Class 2.2 | 注射用伊尼妥单抗 · No verified English nameCXSL2101223 | San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized |
| 2021/07/29New drug · Class 1 | PB-201片 · No verified English nameCXHL2101333 | Pai Ge Biopharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2021/07/29New drug · Class 1 | PB-201片 · No verified English nameCXHL2101332 | Pai Ge Biopharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2021/07/28Import · Class 1 | MK-4280A注射液 · No verified English nameJXSL2101080 | Merck Sharp & Dohme Corp.; MSD R&D (China) Co. Ltd. |
| 2021/07/28Import · Class 2.4 | Lenvatinib Mesilate CapsulesJXHL2101144 | Eisai Europe Ltd. |
| 2021/07/28Import · Class 2.4 | Lenvatinib Mesilate CapsulesJXHL2101143 | Eisai Europe Ltd. |
| 2021/07/28Generic · Class 3 | Citicoline Sodium InjectionCYHS2101492 | Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2021/07/28New drug · Class 1 | 重组抗PD-1人源化单克隆抗体注射液 · No verified English nameCXSL2101221 | San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized |
| 2021/07/28New drug · Class 1 | 注射用QLF32004 · No verified English nameCXSL2101220 | Qilu Pharmaceutical Co., Ltd. |
| 2021/07/28New drug · Class 1 | HS-10375片 · No verified English nameCXHL2101340 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized |
| 2021/07/28New drug · Class 1 | HS-10375片 · No verified English nameCXHL2101339 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized |
| 2021/07/28New drug · Class 1 | ICP-189片 · No verified English nameCXHL2101338 | Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized |
22 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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