YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 327 drug applications between 10 June 2022 and 16 June 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 49, covering 37 drug names.
2022/06/10 – 2022/06/16
- New acceptances this week
- 327
- Drugs with new generic filings (by drug name, de-duplicated)
- 37
- 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
327filings, 49 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 184 |
| Generic | 49 |
| New drug | 46 |
| Import | 29 |
| Import re-registration | 12 |
| Unspecified | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 231 |
| Therapeutic biologic | 58 |
| TCM | 32 |
| Biologic | 4 |
| Prophylactic 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
37 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Olmesartan Medoxomil Tablets | 2 | 1 | 1 |
| 2 | Pravastatin Sodium Tablets | 2 | 1 | 2 |
| 3 | Pregabalin Capsules | 2 | 1 | 12 |
| 4 | 注射用头孢噻肟钠他唑巴坦钠 · No verified English name | 2 | 1 | 1 |
| 5 | Pantoprazole Enteric-Coated Tablets | 2 | 1 | 1 |
| 6 | Rasagiline Mesylate Tablets | 2 | 1 | 5 |
| 7 | Dopamine Hydrochloride Injection | 2 | 1 | 3 |
| 8 | Dapoxetine Hydrochloride Tablets | 2 | 1 | 20 |
| 9 | Oseltamivir Phosphate For Oral Suspension | 2 | 1 | 2 |
| 10 | Minoxidil Topical Solution | 2 | 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
176 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Kai Feng Pharmaceutical (Group) Co., Ltd. romanized | 23 | 20 | 0 |
| 2 | Novo Nordisk A/S | 15 | 3 | 0 |
| 3 | Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized | 9 | 9 | 0 |
| 4 | Hainan Mei Lan Shi Ke Pharmaceutical Co., Ltd. romanized | 5 | 4 | 0 |
| 5 | Janssen-Cilag International NV | 5 | 3 | 0 |
| 6 | Qilu Pharmaceutical Co., Ltd. | 5 | 3 | 1 |
| 7 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized | 5 | 2 | 0 |
| 8 | Lian Cardiovascular Limited | 5 | 1 | 0 |
| 9 | Shenzhen Shi Tian Dao Pharmaceuticals Co., Ltd. romanized | 5 | 1 | 0 |
| 10 | LES LABORATOIRES SERVIER | 4 | 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
83 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/06/16Import · Class 3.1 | 注射用Susoctocog alfa · No verified English nameJXSS2200020 | Baxalta US Inc.; Vetter Pharma-Fertigung GmbH & Co. KG; Takeda (China) International Trading Co. Ltd |
| 2022/06/16Import · Class 1 | JNJ-77242113-AAC片 · No verified English nameJXHL2200148 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/06/16Import · Class 2.4 | Tacrolimus Eye DropsJXHL2200147 | SENJU PHARMACEUTICAL CO. LTD.; Name not romanized |
| 2022/06/16Generic · Class 3 | Esmolol Hydrochloride InjectionCYHS2200896 | Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Hainan Ling Kang Pharmaceutical Co., Ltd. romanized |
| 2022/06/16Generic · Class 3 | Minoxidil LinimentCYHS2200895 | Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2022/06/16Generic · Class 3 | Fluorouracil InjectionCYHS2200893 | Ji Si Mei (Wuhan) Pharmaceutical Co., Ltd. romanized |
| 2022/06/16New drug · Class 1 | 重组抗CD20人源化单克隆抗体皮下注射液 · No verified English nameCXSL2200277 | Shanghai Jiao Lian Drug Research and Development Co., Ltd. romanized |
| 2022/06/16New drug · Class 1 | TG103注射液 · No verified English nameCXSL2200276 | Shi Yao Group Bai Ke (Shandong) Biopharmaceutical Co., Ltd. romanized |
| 2022/06/16New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSL2200275 | Li Zhu Group Xin Bei Jiang Pharmaceutical Co., Ltd. romanized |
| 2022/06/16New drug · Class 1 | HXYT-001细胞注射液 · No verified English nameCXSL2200274 | Hua Xia Ying Tai (Beijing) Bio Technology Co., Ltd. romanized; Beijing Qing Yi Tai Ke Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/06/16New drug · Class 1 | 尘螨过敏原舌下含片 · No verified English nameCXSL2200272 | Ge Lin Mian Yi Ke Xue Co., Ltd. romanized |
| 2022/06/16New drug · Class 1 | 尘螨过敏原舌下含片 · No verified English nameCXSL2200271 | Ge Lin Mian Yi Ke Xue Co., Ltd. romanized |
| 2022/06/16New drug · Class 1 | 尘螨过敏原舌下含片 · No verified English nameCXSL2200270 | Ge Lin Mian Yi Ke Xue Co., Ltd. romanized |
| 2022/06/16New drug · Class 1 | JL14001注射液 · No verified English nameCXSL2200269 | Jie Ku (Shanghai) Biopharmaceuticals Research Co., Ltd. romanized |
| 2022/06/16New drug · Class 1 | 注射用ASKG315 · No verified English nameCXSL2200268 | Jiangsu Ao Sai Kang Biopharmaceuticals Co., Ltd. romanized |
| 2022/06/16New drug · Class 2.2 | 盐酸替扎尼定口服溶液 · No verified English nameCXHL2200394 | Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized |
| 2022/06/16New drug · Class 2.2 | 盐酸替扎尼定口服溶液 · No verified English nameCXHL2200393 | Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized |
| 2022/06/16New drug · Class 1 | D3S-001胶囊 · No verified English nameCXHL2200392 | Name not romanized |
| 2022/06/16New drug · Class 1 | D3S-001胶囊 · No verified English nameCXHL2200391 | Name not romanized |
| 2022/06/16New drug · Class 2.3 | 恩格列净西格列汀二甲双胍缓释片 · No verified English nameCXHL2200390 | Yue Yang Pharmaceuticals Kai Fa (Guangzhou) Co., Ltd. romanized |
| 2022/06/16New drug · Class 1 | QLH11811片 · No verified English nameCXHL2200388 | Qilu Pharmaceutical Co., Ltd. |
| 2022/06/16New drug · Class 1 | QLH11811片 · No verified English nameCXHL2200387 | Qilu Pharmaceutical Co., Ltd. |
| 2022/06/16New drug · Class 1 | QLH12007片 · No verified English nameCXHL2200377 | Qilu Pharmaceutical Co., Ltd. |
| 2022/06/16New drug · Class 1 | AC176胶囊 · No verified English nameCXHL2200376 | Bing Zhou Shi Bio Technology (Shanghai) Co., Ltd. romanized |
| 2022/06/14Import · Class 2.2 | 度伐利尤单抗注射液 · No verified English nameJXSL2200085 | MedImmune LLC; AstraZeneca Investment (China) Co. Limited |
| 2022/06/14Import · Class 2.2 | AV-101(伊马替尼)吸入粉雾剂 · No verified English nameJXHL2200146 | Aerovate Therapeutics Inc.; IQVIA RDS (Shanghai) Co. Ltd. |
| 2022/06/14Import · Class 2.2; 2.4 | AV-101(伊马替尼)吸入粉雾剂 · No verified English nameJXHL2200145 | Aerovate Therapeutics Inc.; IQVIA RDS (Shanghai) Co. Ltd. |
| 2022/06/14Import · Class 2.2; 2.4 | AV-101(伊马替尼)吸入粉雾剂 · No verified English nameJXHL2200144 | Aerovate Therapeutics Inc.; IQVIA RDS (Shanghai) Co. Ltd. |
| 2022/06/14Generic · Class 3 | Dexamethasone Sodium Phosphate InjectionCYHS2200883 | Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized |
| 2022/06/14Generic · Class 3 | Dexmedetomidine Hydrochloride InjectionCYHS2200875 | Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized |
53 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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