YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 236 drug applications between 22 May 2021 and 28 May 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 36, covering 27 drug names.
2021/05/22 – 2021/05/28
- New acceptances this week
- 236
- Drugs with new generic filings (by drug name, de-duplicated)
- 27
- 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
236filings, 36 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 143 |
| Generic | 36 |
| New drug | 28 |
| Import | 19 |
| Import re-registration | 7 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 197 |
| Therapeutic biologic | 25 |
| TCM | 10 |
| Prophylactic biologic | 4 |
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
27 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Escitalopram Oxalate Tablets | 3 | 1 | 6 |
| 2 | Olanzapine Orally Disintegrating Tablets | 2 | 1 | 0 |
| 3 | Ornidazole Injection | 2 | 1 | 0 |
| 4 | Potassium Chloride Granules | 2 | 1 | 4 |
| 5 | Metoprolol Succinate Sustained-release Tablets | 2 | 1 | 4 |
| 6 | Paroxetine Hydrochloride Enteric-Coated Sustained-Release Tablets | 2 | 1 | 0 |
| 7 | 盐酸罗哌卡因氯化钠注射液 · No verified English name | 2 | 1 | 0 |
| 8 | Moxifloxacin Hydrochloride Eye Drops | 2 | 1 | 4 |
| 9 | Sodium Valproate Concentrated Solution for Injection | 1 | 1 | 0 |
| 10 | Ethyl Iosapentate Capsules | 1 | 1 | 27 |
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
120 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | 15 | 14 | 0 |
| 2 | Merck Sharp & Dohme B.V. | 10 | 2 | 0 |
| 3 | Shuang He Pharma (Shenyang) Co., Ltd. romanized | 8 | 2 | 0 |
| 4 | Pfizer Europe MA EEIG | 6 | 3 | 0 |
| 5 | Guangzhou Bai Te Medical Yong Pin Co., Ltd. romanized | 6 | 3 | 0 |
| 6 | Janssen-Cilag International NV | 6 | 1 | 0 |
| 7 | Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized | 6 | 1 | 0 |
| 8 | Takeda Development Center Americas Inc. | 5 | 2 | 0 |
| 9 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 5 | 2 | 0 |
| 10 | Boehringer Ingelheim International GmbH | 5 | 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
60 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/05/28Import · Class 1 | IMGN853 · No verified English nameJXSL2101035 | ImmunoGen Inc.; HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO. LTD |
| 2021/05/28Import · Class 1 | ABL001片 · No verified English nameJXHL2101066 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2021/05/28Import · Class 1 | ABL001片 · No verified English nameJXHL2101065 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2021/05/28Generic · Class 3 | Metformin Hydrochloride Oral SolutionCYHS2101218 | Anhui Xin Shi Ji Pharma Co., Ltd. romanized |
| 2021/05/28New drug · Class 1 | 恩沃利单抗注射液 · No verified English nameCXSL2101099 | Sichuan Si Lu Kang Rui Pharma Co., Ltd. romanized |
| 2021/05/28New drug · Class 3.2 | 冻干ACYW135群脑膜炎球菌结合疫苗 · No verified English nameCXSL2101095 | Suzhou Wei Chao Bio Technology Co., Ltd. romanized |
| 2021/05/28New drug · Class 2.1 | 注射用HR18034 · No verified English nameCXHL2101164 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/05/28New drug · Class 1 | RG001片 · No verified English nameCXHL2101154 | Shanghai Ling Ji Bio Technology Co., Ltd. romanized |
| 2021/05/28New drug · Class 1 | RG001片 · No verified English nameCXHL2101153 | Shanghai Ling Ji Bio Technology Co., Ltd. romanized |
| 2021/05/27Import · Class 1 | BI 456906 注射液 · No verified English nameJXHL2101064 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2021/05/27Import · Class 1 | BI 456906 注射液 · No verified English nameJXHL2101063 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2021/05/27Import · Class 1 | BI 456906 注射液 · No verified English nameJXHL2101062 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2021/05/27Import · Class 1 | BI 456906 注射液 · No verified English nameJXHL2101061 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2021/05/27Import · Class 1 | BI 456906 注射液 · No verified English nameJXHL2101060 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2021/05/27Import · Class 1 | 注射用CEND-1 · No verified English nameJXHL2101059 | Cend Therapeutics Inc.; QILU PHARMACEUTICAL CO. LTD. |
| 2021/05/27Generic · Class 3 | 盐酸考尼伐坦预混型葡萄糖注射液 · No verified English nameCYHS2101216 | Jilin Sheng Bo Da Wei Ye Pharmaceutical Co., Ltd. romanized |
| 2021/05/27Generic · Class 3 | Ethyl Iosapentate CapsulesCYHS2101205 | Sichuan Gowell Pharmaceutical Co., Ltd. |
| 2021/05/27New drug · Class 1 | PA3-17注射液 · No verified English nameCXSL2101097 | Bo Sheng Ji Pharmaceuticals Technology (Suzhou) Co., Ltd. romanized |
| 2021/05/27New drug · Class 1 | 注射用重组人源化单克隆抗体MIL97 · No verified English nameCXSL2101091 | Beijing Tian Guang Shi Bio Technology Co., Ltd. romanized |
| 2021/05/27New drug · Class 2.2 | HR19003贴剂 · No verified English nameCXHL2101163 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/05/27New drug · Class 1 | HS-10376片 · No verified English nameCXHL2101162 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized |
| 2021/05/27New drug · Class 1 | HS-10376片 · No verified English nameCXHL2101161 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized |
| 2021/05/27New drug · Class 1 | Zorifertinib片 · No verified English nameCXHL2101160 | Jiangsu Chen Tai Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/05/27New drug · Class 1 | Zorifertinib片 · No verified English nameCXHL2101159 | Jiangsu Chen Tai Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/05/27New drug · Class 1 | HSK16149胶囊 · No verified English nameCXHL2101158 | Sichuan Hai Si Ke Pharmaceutical Co., Ltd. romanized |
| 2021/05/26Import · Class 1 | BRII-179 (VBI-2601) 注射液 · No verified English nameJXSL2101034 | Brii Biosciences Limited; Brii Biosciences (Beijing) Co. Limited |
| 2021/05/26Import · Class 2.4 | INC280 · No verified English nameJXHL2101058 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd |
| 2021/05/26Import · Class 2.4 | INC280 · No verified English nameJXHL2101057 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd |
| 2021/05/26Import · Class 2.4 | Ponatinib TabletsJXHL2101056 | Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd |
| 2021/05/26Import · Class 2.4 | Ponatinib TabletsJXHL2101055 | Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd |
30 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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