YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 224 drug applications between 1 June 2022 and 7 June 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 31, covering 27 drug names.
2022/06/01 – 2022/06/07
- New acceptances this week
- 224
- Drugs with new generic filings (by drug name, de-duplicated)
- 27
- Accepted this week, now under review
- 2
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
224filings, 31 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 133 |
| Generic | 31 |
| New drug | 28 |
| Import | 19 |
| Unspecified | 7 |
| Import re-registration | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 144 |
| TCM | 45 |
| Therapeutic biologic | 29 |
| Prophylactic biologic | 4 |
| 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
27 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 复方聚乙二醇电解质散(Ⅲ) · No verified English name | 2 | 2 | 1 |
| 2 | Levetiracetam Tablets | 2 | 1 | 6 |
| 3 | Tandospirone Citrate Tablets | 2 | 1 | 2 |
| 4 | 阿普米司特片 · No verified English name | 2 | 1 | 3 |
| 5 | Folic Acid Tablets | 1 | 1 | 12 |
| 6 | Palbociclib Capsules | 1 | 1 | 0 |
| 7 | 复方聚乙二醇电解质散(III) · No verified English name | 1 | 1 | 3 |
| 8 | Peramivir Injection | 1 | 1 | 7 |
| 9 | Lacosamide Injection | 1 | 1 | 0 |
| 10 | Tofacitinib Citrate Tablets | 1 | 1 | 1 |
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
129 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Kai Feng Yu Gang Pharmaceutical Co., Ltd. romanized | 14 | 13 | 0 |
| 2 | Jilin Rui Long Pharma Co., Ltd. romanized | 10 | 10 | 0 |
| 3 | Changchun Hai Wai Pharmaceutical Group Co., Ltd. romanized | 10 | 10 | 0 |
| 4 | Shanghai Lai Shi Xue Ye Zhi Pin Co., Ltd. romanized | 10 | 3 | 0 |
| 5 | Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized | 7 | 7 | 0 |
| 6 | Novartis Pharma AG | 5 | 2 | 0 |
| 7 | Sichuan Sheng Ren De Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Bristol-Myers Squibb Pharma EEIG | 4 | 1 | 0 |
| 9 | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 3 | 2 | 0 |
| 10 | Wuhan Bio Zhi Pin Research Institute Co., Ltd. romanized | 3 | 2 | 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
49 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/06/07Import · Class 1 | Tiragolumab注射液 · No verified English nameJXSL2200071 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2022/06/07New drug · Class 1 | 注射用DB-1305 · No verified English nameCXSL2200248 | Ying En Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2022/06/07New drug · Class 1 | ASKB589注射液 · No verified English nameCXSL2200247 | Jiangsu Ao Sai Kang Biopharmaceuticals Co., Ltd. romanized |
| 2022/06/07New drug · Class 1 | 重组抗EpCAM-CD3抗体注射液 · No verified English nameCXSL2200243 | Tian Mai Yuan He Biopharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2022/06/07New drug · Class 1 | 自体抗CLL-1嵌合抗原受体T细胞注射液 · No verified English nameCXSL2200242 | Guangzhou Bai Ji Ji Yin Technology Co., Ltd. romanized |
| 2022/06/07New drug · Class 3.3 | 水痘减毒活疫苗 · No verified English nameCXSL2200239 | Zhong Yi An Ke Bio Technology Co., Ltd. romanized; Liaoning Mao Kang Yuan Bio Technology Co., Ltd. romanized |
| 2022/06/07New drug · Class 2.2 | 沙库巴曲缬沙坦钠缓释片 · No verified English nameCXHL2200360 | Yue Yang Pharmaceuticals Kai Fa (Guangzhou) Co., Ltd. romanized |
| 2022/06/06Generic · Class 3 | Mannitol-S InjectionCYHS2200836 | Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized |
| 2022/06/06New drug · Class 1 | 伊基仑赛注射液 · No verified English nameCXSS2200055 | Nanjing Xun Lu Biopharmaceuticals Co., Ltd. romanized |
| 2022/06/06New drug · Class 1 | 阴道用四联乳杆菌活菌胶囊 · No verified English nameCXSL2200246 | Sichuan Yan Yang Bio Technology Co., Ltd. romanized |
| 2022/06/06New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSL2200245 | Chongqing Chen An Biopharmaceutical Co., Ltd. romanized; Shanghai Bo Wei Bio Technology Co., Ltd. romanized |
| 2022/06/06New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSL2200244 | Chongqing Chen An Biopharmaceutical Co., Ltd. romanized; Shanghai Bo Wei Bio Technology Co., Ltd. romanized |
| 2022/06/06New drug · Class 1 | XNW1011胶囊 · No verified English nameCXHL2200359 | Xing Lian Pharma (Suzhou) Co., Ltd. romanized |
| 2022/06/03Import · Class 1 | DS-1062a · No verified English nameJXSL2200072 | Daiichi Sankyo Inc.; AstraZeneca Investment (China) Co. Limited |
| 2022/06/03Import · Class 2.2 | 司库奇尤单抗注射液 · No verified English nameJXSL2200070 | Novartis Pharma Schweiz AG; Beijing Novartis Pharma Co. Ltd. |
| 2022/06/03Import · Class 2.2 | 注射用罗特西普 · No verified English nameJXSL2200069 | Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2022/06/03Import · Class 2.2 | 注射用罗特西普 · No verified English nameJXSL2200068 | Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2022/06/03Import · Class 1 | AMG 193 · No verified English nameJXHL2200132 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2022/06/03Import · Class 1 | AMG 193 · No verified English nameJXHL2200131 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2022/06/03Import · Class 1 | AMG 193 · No verified English nameJXHL2200130 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2022/06/03Import · Class 1 | Paltusotine片 · No verified English nameJXHL2200129 | Crinetics Pharmaceuticals Inc.; WuXi Clinical Development Services (Shanghai) Co. Ltd. |
| 2022/06/03Import · Class 1 | Capivasertib · No verified English nameJXHL2200128 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd |
| 2022/06/03Import · Class 1 | Capivasertib · No verified English nameJXHL2200127 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd |
| 2022/06/03Import · Class 1 | MRTX849片 · No verified English nameJXHL2200126 | Mirati Therapeutics Inc.; Zai Lab (Shanghai) Co. Ltd. |
| 2022/06/03Import · Class 1 | LNP023胶囊 · No verified English nameJXHL2200125 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2022/06/03Import · Class 1 | LNP023胶囊 · No verified English nameJXHL2200124 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2022/06/03Generic · Class 3 | Ambroxol Hydrochloride Oral SolutionCYHS2200834 | Guo Yao Group Zhi Jun (Shenzhen) Pharmaceutical Co., Ltd. romanized; Guo Yao Group Zhi Jun (Shenzhen) Ping Shan Pharmaceutical Co., Ltd. romanized |
| 2022/06/03Generic · Class 3 | Flurbiprofen Sodium Eye DropsCYHS2200829 | Wuhan Xian Lu Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Pusch Pharmaceutical Co., Ltd. |
| 2022/06/03New drug · Class 3.3 | 德谷胰岛素注射液 · No verified English nameCXSL2200241 | Nanjing Sai Nuo Biopharmaceutical Co., Ltd. romanized; Nanjing Sai Nuo Bio Technology Co., Ltd. romanized |
| 2022/06/03New drug · Class 2.2 | 四价流感病毒裂解疫苗(MDCK细胞) · No verified English nameCXSL2200240 | Wuhan Bio Zhi Pin Research Institute Co., Ltd. romanized; Lanzhou Bai Ling Bio Technology Co., Ltd. romanized; Xi Bei Min Zu University romanized |
19 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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