YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 280 drug applications between 5 August 2022 and 11 August 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 56, covering 48 drug names.
2022/08/05 – 2022/08/11
- New acceptances this week
- 280
- Drugs with new generic filings (by drug name, de-duplicated)
- 48
- 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
280filings, 56 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 164 |
| Generic | 56 |
| New drug | 38 |
| Import | 11 |
| Unspecified | 5 |
| Import re-registration | 4 |
| Drug-device combination product | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 200 |
| TCM | 53 |
| Therapeutic biologic | 24 |
| Prophylactic biologic | 3 |
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
48 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Salbutamol Sulfate Inhalation Solution | 3 | 1 | 2 |
| 2 | Acetylcysteine Granules | 2 | 1 | 4 |
| 3 | Ornidazole Injection | 2 | 1 | 0 |
| 4 | Empagliflozin Tablets | 2 | 1 | 18 |
| 5 | Temozolomide Capsules | 2 | 1 | 0 |
| 6 | Vortioxetine Hydrobromide Tablets | 2 | 1 | 10 |
| 7 | Ambroxol Hydrochloride Oral Solution | 2 | 1 | 46 |
| 8 | 丁酸氯维地平乳状注射液 · No verified English name | 1 | 1 | 0 |
| 9 | 低钙腹膜透析液(乳酸盐-G1.5%) · No verified English name | 1 | 1 | 3 |
| 10 | 低钙腹膜透析液(乳酸盐-G2.5%) · No verified English name | 1 | 1 | 4 |
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
161 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | 41 | 36 | 0 |
| 2 | Shanxi Tong Da Pharma Co., Ltd. romanized | 8 | 8 | 0 |
| 3 | Guangxi Xiu Zheng Pharmaceutical Co., Ltd. romanized | 7 | 5 | 0 |
| 4 | Beijing Yu Sheng Tang Group Shijiazhuang Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Shanxi Fen He Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 6 | Boehringer Ingelheim International GmbH | 4 | 4 | 0 |
| 7 | Hebei Wu Luo Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Hainan Tong Yong Kang Li Pharmaceutical Co., Ltd. romanized | 4 | 1 | 0 |
| 9 | Guizhou De Liang Fang Pharma Co., Ltd. romanized | 3 | 3 | 0 |
| 10 | Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized | 3 | 2 | 3 |
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
69 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/08/11Import · Class 1 | XXB750注射液 · No verified English nameJXSL2200132 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2022/08/11Import · Class 1 | LOXO-783片 · No verified English nameJXHL2200239 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2022/08/11Import · Class 1 | LOXO-783片 · No verified English nameJXHL2200238 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2022/08/11Generic · Class 3 | Lamotrigine Extended Release TabletsCYHS2201288 | Shanghai Ao Ke Da Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized |
| 2022/08/11Generic · Class 3 | Minoxidil LinimentCYHS2201287 | Zhejiang Yuan Li Jian Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2022/08/11Generic · Class 3 | Ambroxol Hydrochloride Oral SolutionCYHS2201283 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2022/08/11Generic · Class 3 | Ambroxol Hydrochloride Oral SolutionCYHS2201282 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2022/08/11Generic · Class 3 | Lidocaine Hydrochloride InjectionCYHS2201281 | Tong He Biopharmaceuticals (Shandong) Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized |
| 2022/08/11New drug · Class 1 | CUD002注射液 · No verified English nameCXSL2200371 | Sichuan Kang De Sai Medical Technology Co., Ltd. romanized |
| 2022/08/11New drug · Class 2.2 | 格隆溴铵吸入喷雾剂 · No verified English nameCXHL2200582 | Shanghai Gu Sen Pharmaceuticals Co., Ltd. romanized |
| 2022/08/11New drug · Class 1 | CS0159片 · No verified English nameCXHL2200581 | Kai Si Kai Di (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/08/11New drug · Class 1 | CS0159片 · No verified English nameCXHL2200580 | Kai Si Kai Di (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/08/11New drug · Class 1 | VD1219片 · No verified English nameCXHL2200565 | Wei Shen Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2022/08/11New drug · Class 1 | VD1219片 · No verified English nameCXHL2200564 | Wei Shen Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2022/08/10Import · Class 1 | 珂罗利单抗注射液 · No verified English nameJXSS2200031 | Roche Pharma (Schweiz) AG; Genentech Inc.; Roche (China) Holding Ltd. |
| 2022/08/10Generic · Class 3 | Calcium Gluconate InjectionCYHS2201280 | Shandong Qidu Pharmaceutical Co., Ltd. |
| 2022/08/10Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2201271 | Zhejiang Huan Ling Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized |
| 2022/08/10New drug · Class 1 | 人脐带间充质干细胞注射液 · No verified English nameCXSL2200370 | Beijing Bei Lai Bio Technology Co., Ltd. romanized |
| 2022/08/10New drug · Class 1 | VGR-R01 · No verified English nameCXSL2200369 | Shanghai Tian Ze Yun Tai Biopharmaceuticals Co., Ltd. romanized |
| 2022/08/10New drug · Class 1 | SYS6002 · No verified English nameCXSL2200368 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2022/08/10New drug · Class 3.3 | 冻干b型流感嗜血杆菌结合疫苗 · No verified English nameCXSL2200367 | Chengdu Ou Lin Bio Technology Co., Ltd. romanized |
| 2022/08/10New drug · Class 2.2 | 甲磺酸雷沙吉兰舌下膜 · No verified English nameCXHL2200579 | Shanghai Shang Yao Zhong Xi Pharmaceutical Co., Ltd. romanized |
| 2022/08/10New drug · Class 1 | XNW5004片 · No verified English nameCXHL2200578 | Suzhou Xin Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/08/10New drug · Class 1 | XNW5004片 · No verified English nameCXHL2200577 | Suzhou Xin Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/08/10New drug · Class 1 | XNW5004片 · No verified English nameCXHL2200576 | Suzhou Xin Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/08/09Generic · Class 3 | Isoniazid InjectionCYHS2201267 | Shenyang Shuang Ding Pharmaceutical Co., Ltd. romanized |
| 2022/08/09Generic · Class 3 | Ibuprofen GranulesCYHS2201266 | Rui Yang Pharmaceutical Co., Ltd. romanized |
| 2022/08/09Generic · Class 3 | 丁酸氯维地平乳状注射液 · No verified English nameCYHS2201262 | Nanjing You Ke Pharmaceutical Co., Ltd. romanized |
| 2022/08/09Generic · Class 3 | 核黄素磷酸钠滴眼液 · No verified English nameCYHS2201261 | Ningxia Kang Ya Pharma Co., Ltd. romanized |
| 2022/08/09Generic · Class 3 | Esmolol Hydrochloride InjectionCYHS2201260 | Beijing Bai Mei Te Biopharmaceutical Co., Ltd. romanized |
39 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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