YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 241 drug applications between 4 August 2022 and 10 August 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 53, covering 47 drug names.
2022/08/04 – 2022/08/10
- New acceptances this week
- 241
- Drugs with new generic filings (by drug name, de-duplicated)
- 47
- 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
241filings, 53 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 123 |
| Generic | 53 |
| New drug | 37 |
| Import | 16 |
| Unspecified | 8 |
| Import re-registration | 3 |
| Drug-device combination product | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 164 |
| TCM | 44 |
| Therapeutic biologic | 27 |
| Prophylactic biologic | 4 |
| 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
47 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 | Gadobutrol Injection | 2 | 1 | 8 |
| 6 | 丁酸氯维地平乳状注射液 · No verified English name | 1 | 1 | 0 |
| 7 | 低钙腹膜透析液(乳酸盐-G1.5%) · No verified English name | 1 | 1 | 3 |
| 8 | 低钙腹膜透析液(乳酸盐-G2.5%) · No verified English name | 1 | 1 | 4 |
| 9 | Ebastine Oral Solution | 1 | 1 | 9 |
| 10 | Lidocaine and Prilocaine Cream | 1 | 1 | 24 |
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
140 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | 40 | 35 | 0 |
| 2 | Shanxi Tong Da Pharma Co., Ltd. romanized | 8 | 8 | 0 |
| 3 | Celgene Corporation | 6 | 1 | 0 |
| 4 | Guangxi Xiu Zheng Pharmaceutical Co., Ltd. romanized | 5 | 3 | 0 |
| 5 | Boehringer Ingelheim International GmbH | 4 | 4 | 0 |
| 6 | OM Pharma SA | 4 | 2 | 0 |
| 7 | Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized | 3 | 3 | 0 |
| 8 | Guizhou De Liang Fang Pharma Co., Ltd. romanized | 3 | 3 | 0 |
| 9 | Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized | 3 | 2 | 3 |
| 10 | Bayer HealthCare LLC | 3 | 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
70 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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 |
| 2022/08/09Generic · Class 3 | Salbutamol Sulfate Inhalation SolutionCYHS2201258 | Li Sheng Pharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2022/08/09Generic · Class 3 | Salbutamol Sulfate Inhalation SolutionCYHS2201257 | Li Sheng Pharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2022/08/09New drug · Class 1 | HLX60 · No verified English nameCXSL2200366 | Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized |
| 2022/08/08Generic · Class 3 | Carbazochrome Sodium Sulfonate InjectionCYHS2201256 | Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2022/08/08Generic · Class 3 | Ampicillin Sodium For InjectionCYHS2201253 | Shanxi Ming Yu Bio Technology Co., Ltd. romanized; Shandong Lukang Pharmaceutical Co.,Ltd. |
| 2022/08/08Generic · Class 3 | Aripiprazole Oral SolutionCYHS2201251 | Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized |
| 2022/08/08Generic · Class 3 | Ornidazole InjectionCYHS2201250 | Xian Xin Bai Xin Pharmaceuticals Technology Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized |
| 2022/08/08Generic · Class 3 | Ornidazole InjectionCYHS2201249 | Xian Xin Bai Xin Pharmaceuticals Technology Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized |
| 2022/08/08Generic · Class 3 | Citicoline Sodium InjectionCYHS2201248 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2022/08/08Generic · Class 3 | 低钙腹膜透析液(乳酸盐-G2.5%) · No verified English nameCYHS2201233 | Anhui Feng Yuan Pharma Co., Ltd. romanized |
| 2022/08/08Generic · Class 3 | 低钙腹膜透析液(乳酸盐-G1.5%) · No verified English nameCYHS2201232 | Anhui Feng Yuan Pharma Co., Ltd. romanized |
| 2022/08/08New drug · Class 1.1 | 通降颗粒 · No verified English nameCXZL2200037 | Jian Min Pharma Group Co., Ltd. romanized |
| 2022/08/08New drug · Class 2.3 | 舒肝解郁胶囊 · No verified English nameCXZL2200036 | Sichuan Ji Sheng Tang Pharma Co., Ltd. romanized |
| 2022/08/08New drug · Class 1 | 欧司珀利单抗注射液 · No verified English nameCXSL2200365 | Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized |
40 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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