YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 263 drug applications between 26 June 2022 and 2 July 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 43, covering 33 drug names.
2022/06/26 – 2022/07/02
- New acceptances this week
- 263
- Drugs with new generic filings (by drug name, de-duplicated)
- 33
- 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
263filings, 43 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 112 |
| New drug | 63 |
| Generic | 43 |
| Import | 20 |
| Import re-registration | 14 |
| Unspecified | 11 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 201 |
| Therapeutic biologic | 36 |
| TCM | 22 |
| Prophylactic biologic | 3 |
| 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
33 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Tedizolid Phosphate Tablets | 3 | 3 | 1 |
| 2 | Dapoxetine Hydrochloride Tablets | 3 | 2 | 20 |
| 3 | Norepinephrine Bitartrate Injection | 2 | 2 | 9 |
| 4 | Levofloxacin Injection | 2 | 1 | 1 |
| 5 | Empagliflozin Tablets | 2 | 1 | 18 |
| 6 | 盐酸多奈哌齐口崩片 · No verified English name | 2 | 1 | 0 |
| 7 | 苯磺酸左氨氯地平片 · No verified English name | 2 | 1 | 45 |
| 8 | Atorvastatin Calcium Tablets | 2 | 1 | 24 |
| 9 | Etoricoxib Tablets | 1 | 1 | 8 |
| 10 | Pentazocine Injection | 1 | 1 | 0 |
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
164 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Bayer AG | 6 | 6 | 0 |
| 2 | Hebei Wu Luo Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 3 | Hubei Kang Wei Yuan Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 4 | Ren He Yi Kang Group Co., Ltd. romanized | 6 | 4 | 0 |
| 5 | Hangzhou Bang Shun Pharmaceutical Co., Ltd. romanized | 6 | 1 | 0 |
| 6 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 4 | 2 | 0 |
| 7 | Suzhou Ya Sheng Pharma Co., Ltd. romanized | 4 | 2 | 0 |
| 8 | Novartis Pharma Schweiz AG | 4 | 1 | 0 |
| 9 | Pfizer Europe MA EEIG | 4 | 1 | 0 |
| 10 | Shanghai Jia Tan Pharmaceuticals Technology Co., Ltd. romanized | 4 | 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
84 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/07/02Import · Class 3.3 | 贝伐珠单抗注射液 · No verified English nameJXSL2200099 | Joint Stock Company“BIOCAD”,(JSC“BIOCAD”); SPH-Biocad Biopharmaceuticals (SH) Co. Ltd. |
| 2022/07/02Import · Class 3.3 | 贝伐珠单抗注射液 · No verified English nameJXSL2200098 | Joint Stock Company“BIOCAD”,(JSC“BIOCAD”); SPH-Biocad Biopharmaceuticals (SH) Co. Ltd. |
| 2022/07/02Import · Class 2.2 | Amivantamab注射液 · No verified English nameJXSL2200095 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/07/02New drug · Class 1 | BA1106注射液 · No verified English nameCXSL2200307 | Shandong Bo An Bio Technology Co., Ltd. romanized |
| 2022/07/02New drug · Class 1 | LTC004 · No verified English nameCXSL2200306 | Beijing Zhi Dao Bio Technology Co., Ltd. romanized |
| 2022/07/02New drug · Class 1 | 注射用低分子量岩藻糖化糖胺聚糖钠 · No verified English nameCXSL2200305 | Mu Dan Jiang You Bo Pharma Co., Ltd. romanized |
| 2022/07/02New drug · Class 1 | 靶向GPC3嵌合抗原受体自体T细胞注射液 · No verified English nameCXSL2200304 | Yuan Qi Bio Technology (Shanghai) Co., Ltd. romanized |
| 2022/07/02New drug · Class 1 | AK119注射液 · No verified English nameCXSL2200296 | Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized |
| 2022/07/02New drug · Class 1 | JBPOS0101胶囊 · No verified English nameCXHL2200463 | ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD. |
| 2022/07/02New drug · Class 1 | JBPOS0101胶囊 · No verified English nameCXHL2200462 | ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD. |
| 2022/07/02New drug · Class 1 | JBPOS0101胶囊 · No verified English nameCXHL2200461 | ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD. |
| 2022/07/02New drug · Class 1 | GW201片 · No verified English nameCXHL2200460 | Beijing Guang Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/07/02New drug · Class 1 | GW201片 · No verified English nameCXHL2200459 | Beijing Guang Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/07/02New drug · Class 1 | GW201片 · No verified English nameCXHL2200458 | Beijing Guang Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/07/02New drug · Class 1 | EVER001胶囊 · No verified English nameCXHL2200454 | Yun Ding Xin Yao Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/06/30Generic · Class 3 | Nicergoline TabletsCYHS2200980 | Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanized; ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD. |
| 2022/06/30Generic · Class 3 | Levofloxacin InjectionCYHS2200978 | Changchun Hai Yue Pharma Co., Ltd. romanized |
| 2022/06/30Generic · Class 3 | Levofloxacin InjectionCYHS2200977 | Changchun Hai Yue Pharma Co., Ltd. romanized |
| 2022/06/30Generic · Class 3 | Peramivir InjectionCYHS2200976 | Suzhou Ai Mei Jin Pharmaceutical Co., Ltd. romanized; Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized |
| 2022/06/30Generic · Class 3 | Anagrelide Hydrochloride CapsulesCYHS2200937 | Heilongjiang Tian Hong Pharma Co., Ltd. romanized |
| 2022/06/30New drug · Class 1 | RY_SW01细胞注射液 · No verified English nameCXSL2200303 | Jiangsu Rui Yuan Bio Technology Co., Ltd. romanized |
| 2022/06/30New drug · Class 1 | KY-0118 注射剂 · No verified English nameCXSL2200302 | Shanghai Ke Yi Pharma Technology Co., Ltd. romanized |
| 2022/06/30New drug · Class 1 | 注射用贺普拉肽 · No verified English nameCXHL2200457 | Shanghai He Pu Pharma Co., Ltd. romanized |
| 2022/06/29Import · Class 2.2 | Amivantamab注射液 · No verified English nameJXSL2200097 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/06/29Import · Class 1 | FT-001注射液 · No verified English nameJXSL2200096 | Frontera Therapeutics Inc.; Suzhou Frontera Therapeutics Co. Ltd. |
| 2022/06/29Import · Class 1 | BIIB122 · No verified English nameJXHL2200167 | Biogen Idec Research Limited; Biogen Biotechnology (Shanghai) Co. Ltd |
| 2022/06/29Import · Class 2.4 | Tazemetostat Hydrobromide片 · No verified English nameJXHL2200166 | HUTCHMED (Hong Kong) Limited; HUTCHMED Limited |
| 2022/06/29Generic · Class 3 | Norepinephrine Bitartrate InjectionCYHS2200969 | Guangzhou Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2022/06/29New drug · Class 3.3 | 特立帕肽注射液 · No verified English nameCXSS2200062 | Beijing Bo Kang Jian Ji Yin Technology Co., Ltd. romanized |
| 2022/06/29New drug · Class 2.6 | 20价肺炎球菌多糖结合疫苗 · No verified English nameCXSL2200300 | Ai Mei Wei Xin Bio Pharma (Zhejiang) Co., Ltd. romanized; Ai Mei Tan Suo Zhe Sheng Ming Ke Xue Research and Development Co., Ltd. romanized; Ai Mei Yi Miao Co., Ltd. romanized |
54 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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