YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 80 drug applications between 2 February 2022 and 8 February 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 20, covering 12 drug names.
2022/02/02 – 2022/02/08
- New acceptances this week
- 80
- Drugs with new generic filings (by drug name, de-duplicated)
- 12
- 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
80filings, 20 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 33 |
| Generic | 20 |
| New drug | 14 |
| Import | 10 |
| Import re-registration | 2 |
| Unspecified | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 61 |
| Therapeutic biologic | 10 |
| TCM | 8 |
| Prophylactic 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
12 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Olmesartan Medoxomil and Amlodipine and Hydrochlorothiazide Tablets | 5 | 1 | 5 |
| 2 | Rivaroxaban Tablets | 3 | 2 | 3 |
| 3 | Empagliflozin Tablets | 2 | 1 | 18 |
| 4 | Esomeprazole Magnesium Enteric-Coated Capsules | 2 | 1 | 4 |
| 5 | 利奈唑胺氯化钠注射液 · No verified English name | 1 | 1 | 0 |
| 6 | 氧 · No verified English name | 1 | 1 | 15 |
| 7 | Sodium Hyaluronate Eye Drops | 1 | 1 | 30 |
| 8 | Memantine Hydrochloride Oral Solution | 1 | 1 | 0 |
| 9 | Amantadine Hydrochloride Tablets | 1 | 1 | 0 |
| 10 | Calcium Gluconate Injection | 1 | 1 | 5 |
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
50 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | AstraZeneca AB | 5 | 1 | 0 |
| 2 | Shanghai Teng Rui Pharmaceutical Co., Ltd. romanized | 5 | 1 | 5 |
| 3 | Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized | 3 | 1 | 0 |
| 4 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 3 | 1 | 0 |
| 5 | CSPC OUYI PHARMACEUTICAL CO., LTD. | 3 | 1 | 0 |
| 6 | Jilin Tian Heng Pharma Co., Ltd. romanized | 2 | 2 | 1 |
| 7 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized | 2 | 2 | 0 |
| 8 | Hainan Brilliant Pharmaceutical Co., Ltd. | 2 | 2 | 0 |
| 9 | Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized | 2 | 2 | 0 |
| 10 | Suzhou Yu Sen Xin Yao Kai Fa Co., Ltd. romanized | 2 | 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
28 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/02/08Import · Class 2.4 | Ibrexafungerp片 · No verified English nameJXHL2200036 | SCYNEXIS Inc.; JIANGSU HANSOH PHARMACEUTICAL GROUP CO. LTD |
| 2022/02/08Generic · Class 3 | Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2200278 | Suzhou Te Rui Pharma Co., Ltd. romanized |
| 2022/02/08Generic · Class 3 | Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2200277 | Suzhou Te Rui Pharma Co., Ltd. romanized |
| 2022/02/08Generic · Class 3 | Olmesartan Medoxomil and Amlodipine and Hydrochlorothiazide TabletsCYHS2200276 | Shanghai Teng Rui Pharmaceutical Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized |
| 2022/02/08Generic · Class 3 | Olmesartan Medoxomil and Amlodipine and Hydrochlorothiazide TabletsCYHS2200275 | Shanghai Teng Rui Pharmaceutical Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized |
| 2022/02/08Generic · Class 3 | Olmesartan Medoxomil and Amlodipine and Hydrochlorothiazide TabletsCYHS2200274 | Shanghai Teng Rui Pharmaceutical Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized |
| 2022/02/08Generic · Class 3 | Olmesartan Medoxomil and Amlodipine and Hydrochlorothiazide TabletsCYHS2200273 | Shanghai Teng Rui Pharmaceutical Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized |
| 2022/02/08Generic · Class 3 | Olmesartan Medoxomil and Amlodipine and Hydrochlorothiazide TabletsCYHS2200272 | Shanghai Teng Rui Pharmaceutical Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized |
| 2022/02/08Generic · Class 3 | Amantadine Hydrochloride TabletsCYHS2200269 | Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. |
| 2022/02/08Generic · Class 3 | Calcium Gluconate InjectionCYHS2200264 | Hubei Xin Ze Fei Pharma Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized |
| 2022/02/08Generic · Class 3 | Memantine Hydrochloride Oral SolutionCYHS2200221 | Hangzhou He Kang Pharma Co., Ltd. romanized; Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized |
| 2022/02/08New drug · Class 1.2 | 开拓普片 · No verified English nameCXZL2200007 | Suzhou Yu Sen Xin Yao Kai Fa Co., Ltd. romanized |
| 2022/02/08New drug · Class 1.2 | 梓醇 · No verified English nameCXZL2200006 | Suzhou Yu Sen Xin Yao Kai Fa Co., Ltd. romanized |
| 2022/02/08New drug · Class 1.1 | 枣柏安神颗粒 · No verified English nameCXZL2200004 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized |
| 2022/02/08New drug · Class 1 | QL1706注射液 · No verified English nameCXSL2200076 | Qilu Pharmaceutical Co., Ltd. |
| 2022/02/08New drug · Class 1 | 注射用BL-M02D1 · No verified English nameCXSL2200075 | Sichuan Bai Li Pharma Co., Ltd. romanized; Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized |
| 2022/02/08New drug · Class 1 | 3D-229注射液 · No verified English nameCXSL2200073 | Xu Zhou Si Lu Di Pharma Co., Ltd. romanized |
| 2022/02/08New drug · Class 1 | HSK36212胶囊 · No verified English nameCXHL2200075 | Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized |
| 2022/02/08New drug · Class 1 | HSK36212胶囊 · No verified English nameCXHL2200074 | Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized |
| 2022/02/08New drug · Class 1 | HSK36212胶囊 · No verified English nameCXHL2200073 | Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized |
| 2022/02/07Import · Class 2.2 | 诺西那生钠注射液 · No verified English nameJXHL2200035 | Biogen Idec Research Limited; Biogen Biotechnology (Shanghai) Co. Ltd |
| 2022/02/07Import · Class 2.2 | 诺西那生钠注射液 · No verified English nameJXHL2200034 | Biogen Idec Research Limited; Biogen Biotechnology (Shanghai) Co. Ltd |
| 2022/02/07Generic · Class 3 | 利奈唑胺氯化钠注射液 · No verified English nameCYHS2200067 | Jiangsu Wu Zhong Pharmaceuticals Group Co., Ltd. Suzhou Pharmaceutical Factory romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized |
| 2022/02/07New drug · Class 3.4 | 注射用重组人凝血因子Ⅷ · No verified English nameCXSS2200013 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2022/02/07New drug · Class 1 | SHR-2004注射液 · No verified English nameCXSL2200072 | Beijing Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2022/02/07New drug · Class 1 | TQH2722注射液 · No verified English nameCXSL2200071 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2022/02/07New drug · Class 1 | 重组人源化抗PD-1单克隆抗体注射液 · No verified English nameCXSL2200069 | Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized |
| 2022/02/07New drug · Class 1 | 重组全人源抗人表皮生长因子受体单克隆抗体注射液 · No verified English nameCXSL2200068 | Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized |
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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