YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 296 drug applications between 14 November 2022 and 20 November 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 51, covering 38 drug names.
2022/11/14 – 2022/11/20
- New acceptances this week
- 296
- Drugs with new generic filings (by drug name, de-duplicated)
- 38
- 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
296filings, 51 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 179 |
| Generic | 51 |
| New drug | 38 |
| Import | 13 |
| Unspecified | 8 |
| Import re-registration | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 220 |
| TCM | 48 |
| Therapeutic biologic | 28 |
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
38 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Palbociclib Capsules | 3 | 1 | 0 |
| 2 | Lidocaine Hydrochloride Injection | 3 | 1 | 6 |
| 3 | Sitagliptin Phosphate Tablets | 3 | 1 | 2 |
| 4 | Tadalafil Tablets | 2 | 1 | 23 |
| 5 | Lamotrigine Tablets | 2 | 1 | 0 |
| 6 | Sildenafil Citrate Tablets | 2 | 1 | 12 |
| 7 | Esomeprazole Sodium for Injection | 2 | 1 | 1 |
| 8 | Procaterol Hydrochloride Oral Solution | 2 | 1 | 12 |
| 9 | Escitalopram Oxalate Tablets | 2 | 1 | 6 |
| 10 | Dapagliflozin Tablets | 2 | 1 | 84 |
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
156 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jilin Sheng Shang Cheng Pharma Co., Ltd. romanized | 17 | 13 | 0 |
| 2 | Henan Shuang He Hua Li Pharma Co., Ltd. romanized | 12 | 3 | 0 |
| 3 | Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized | 9 | 9 | 0 |
| 4 | Hefei Hua Fang Pharmaceuticals Technology Co., Ltd. romanized | 7 | 7 | 0 |
| 5 | GE Healthcare AS | 7 | 1 | 0 |
| 6 | Boehringer Ingelheim International GmbH | 6 | 1 | 0 |
| 7 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized | 6 | 1 | 0 |
| 8 | Hua Run San Jiu (Chen Zhou) Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 9 | Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanized | 5 | 4 | 0 |
| 10 | UCB Pharma SA | 5 | 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
60 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/11/19Import · Class 1 | BAY 2433334片 · No verified English nameJXHL2200339 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2022/11/19Generic · Class 3 | 注射用泮托拉唑钠(Ⅰ) · No verified English nameCYHS2202017 | Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Guangdong Long Fu Pharma Co., Ltd. romanized |
| 2022/11/19New drug · Class 1 | SAL0119片 · No verified English nameCXHL2200915 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2022/11/19New drug · Class 1 | SAL0119片 · No verified English nameCXHL2200914 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2022/11/19New drug · Class 1 | SAL0119片 · No verified English nameCXHL2200913 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2022/11/19New drug · Class 1 | SAL0119片 · No verified English nameCXHL2200912 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2022/11/19New drug · Class 1 | SAL0119片 · No verified English nameCXHL2200911 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2022/11/19New drug · Class 1 | SAL0119片 · No verified English nameCXHL2200910 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2022/11/19New drug · Class 1 | BR1733片 · No verified English nameCXHL2200909 | Shanghai Qing Yu Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/11/19New drug · Class 1 | BR1733片 · No verified English nameCXHL2200908 | Shanghai Qing Yu Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/11/19New drug · Class 1 | KF-0210片 · No verified English nameCXHL2200907 | Kai Fu (Suzhou) Biopharmaceuticals Co., Ltd. romanized |
| 2022/11/19New drug · Class 1 | KF-0210片 · No verified English nameCXHL2200906 | Kai Fu (Suzhou) Biopharmaceuticals Co., Ltd. romanized |
| 2022/11/18Generic · Class 3 | Naloxone Hydrochloride InjectionCYHS2202015 | Chongqing Lai Mei Pharma Co., Ltd. romanized |
| 2022/11/18Generic · Class 3 | 头孢克肟颗粒 · No verified English nameCYHS2201935 | Hefei En Rui Te Pharma Co., Ltd. romanized; Anhui An Ke Heng Yi Pharma Co., Ltd. romanized |
| 2022/11/18New drug · Class 3.4 | 人凝血酶原复合物 · No verified English nameCXSS2200091 | Shenzhen Shi Wei Guang Bio Zhi Pin Co., Ltd. romanized |
| 2022/11/18New drug · Class 1 | 注射用IMM0306 · No verified English nameCXSL2200583 | Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2022/11/18New drug · Class 1 | 注射用PRO1184 · No verified English nameCXSL2200582 | Pu Fang Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2022/11/18New drug · Class 1 | ELPIS人脐带间充质干细胞注射液 · No verified English nameCXSL2200581 | Hua Xia Yuan (Shanghai) Bio Technology Co., Ltd. romanized |
| 2022/11/17Generic · Class 3 | Digoxin InjectionCYHS2202003 | Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2022/11/17Generic · Class 3 | Formoterol Fumarate Inhalation SolutionCYHS2202000 | Shanghai Ao Ke Da Pharmaceuticals Technology Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized |
| 2022/11/17New drug · Class 1.1 | 金连消风颗粒 · No verified English nameCXZL2200052 | Ying Ke Rui (Tianjin) Innovation Pharmaceuticals Research Co., Ltd. romanized |
| 2022/11/17New drug · Class 1 | 注射用BB-1709 · No verified English nameCXSL2200580 | Bai Li Si Kang Biopharmaceuticals (Hangzhou) Co., Ltd. romanized |
| 2022/11/17New drug · Class 2.2 | 普特利单抗注射液 · No verified English nameCXSL2200578 | Le Pu Bio Technology Co., Ltd. romanized |
| 2022/11/17New drug · Class 1 | GC012F注射液 · No verified English nameCXSL2200577 | Suzhou Gen Xi Bio Technology Co., Ltd. romanized; Gen Xi Bio Technology (Shanghai) Co., Ltd. romanized |
| 2022/11/17New drug · Class 2.2 | 马来酸噻吗洛尔乳膏 · No verified English nameCXHL2200905 | Shanghai Fu Dan Zhang Jiang Biopharmaceuticals Co., Ltd. romanized |
| 2022/11/17New drug · Class 1 | BEBT-503胶囊 · No verified English nameCXHL2200904 | Guangzhou Bi Bei Te Pharmaceuticals Co., Ltd. romanized |
| 2022/11/17New drug · Class 1 | BEBT-503胶囊 · No verified English nameCXHL2200903 | Guangzhou Bi Bei Te Pharmaceuticals Co., Ltd. romanized |
| 2022/11/17New drug · Class 1 | WS012干混悬剂 · No verified English nameCXHL2200902 | Zhong Mei Hua Shi Tong Biopharmaceuticals Technology (Wuhan) Co., Ltd. romanized |
| 2022/11/16Import · Class 3.1 | 司库奇尤单抗注射液 · No verified English nameJXSS2200036 | Novartis Pharma Schweiz AG; Novartis Pharma Stein AG; Beijing Novartis Pharma Co. Ltd. |
| 2022/11/16Import · Class 3.1 | 司库奇尤单抗注射液 · No verified English nameJXSS2200035 | Novartis Pharma Schweiz AG; Novartis Pharma Stein AG; Beijing Novartis Pharma 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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