YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 61 drug applications between 3 October 2022 and 9 October 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 16, covering 10 drug names.
2022/10/03 – 2022/10/09
- New acceptances this week
- 61
- Drugs with new generic filings (by drug name, de-duplicated)
- 10
- 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
61filings, 16 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 26 |
| New drug | 17 |
| Generic | 16 |
| Unspecified | 1 |
| Import | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 53 |
| TCM | 4 |
| Therapeutic biologic | 4 |
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
10 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Diquafosol Sodium Eye Drops | 3 | 2 | 5 |
| 2 | Sodium Valproate Concentrated Solution for Injection | 2 | 1 | 0 |
| 3 | 复方醋酸钠林格注射液 · No verified English name | 2 | 1 | 2 |
| 4 | Montelukast Sodium Chewable Tablets | 2 | 1 | 4 |
| 5 | Ondansetron Hydrochloride Injection | 2 | 1 | 5 |
| 6 | Compound Ipratropium Bromide Solution For Inhalation | 1 | 1 | 4 |
| 7 | Pregabalin Orally Disintegrating Tablets | 1 | 1 | 3 |
| 8 | Sildenafil Citrate Oral Disintegrating Tablets | 1 | 1 | 8 |
| 9 | Methocarbamol Injection | 1 | 1 | 3 |
| 10 | Cilostazol Tablets | 1 | 1 | 1 |
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
42 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Guangxi Ling Yun Xian Pharmaceutical Co., Ltd. romanized | 3 | 3 | 0 |
| 2 | Henan Li Xin Pharmaceutical Co., Ltd. romanized | 3 | 1 | 0 |
| 3 | Janssen Research & Development LLC | 2 | 1 | 0 |
| 4 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized | 2 | 1 | 0 |
| 5 | Zhongshan Wanhan Pharmaceuticals Co., Ltd. | 2 | 1 | 2 |
| 6 | Beijing Liu Huan Pharma Co., Ltd. romanized | 2 | 1 | 0 |
| 7 | Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized | 2 | 1 | 2 |
| 8 | Bo Rui Xin Chuang Biopharmaceuticals Technology (Wuxi) Co., Ltd. romanized | 2 | 1 | 0 |
| 9 | Shandong Lukang Pharmaceutical Co.,Ltd. | 2 | 1 | 0 |
| 10 | Guangdong Da Xiang Pharmaceutical Co., Ltd. romanized | 2 | 1 | 2 |
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
25 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/10/09Import · Class 1 | Ritlecitinib胶囊 · No verified English nameJXHL2200297 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2022/10/09Generic · Class 3 | Pregabalin Orally Disintegrating TabletsCYHS2201675 | Guangzhou Di Qi Pharmaceuticals Technology Co., Ltd. romanized; Chongqing Huapont Pharmaceutical Co., Ltd. |
| 2022/10/09Generic · Class 3 | 复方醋酸钠林格注射液 · No verified English nameCYHS2201674 | Guangdong Da Xiang Pharmaceutical Co., Ltd. romanized |
| 2022/10/09Generic · Class 3 | 复方醋酸钠林格注射液 · No verified English nameCYHS2201673 | Guangdong Da Xiang Pharmaceutical Co., Ltd. romanized |
| 2022/10/09Generic · Class 3 | Sodium Valproate Concentrated Solution for InjectionCYHS2201670 | Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized |
| 2022/10/09Generic · Class 3 | Sodium Valproate Concentrated Solution for InjectionCYHS2201669 | Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized |
| 2022/10/09New drug · Class 1 | SAL008注射液 · No verified English nameCXSL2200503 | Xin Li Tai (Chengdu) Bio Technology Co., Ltd. romanized; Xin Li Tai (Suzhou) Pharma Co., Ltd. romanized; Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2022/10/09New drug · Class 1 | ALMB-0166注射液 · No verified English nameCXSL2200502 | Shanghai En Le Mai Bio Technology Co., Ltd. romanized |
| 2022/10/09New drug · Class 2.4 | Pyrotinib Maleate TabletsCXHS2200053 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2022/10/09New drug · Class 2.4 | Pyrotinib Maleate TabletsCXHS2200052 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2022/10/09New drug · Class 1 | TL118颗粒 · No verified English nameCXHL2200763 | Suzhou Tao Lve Bio Technology Co., Ltd. romanized |
| 2022/10/09New drug · Class 1 | BGM0504注射液 · No verified English nameCXHL2200762 | Bo Rui Xin Chuang Biopharmaceuticals Technology (Wuxi) Co., Ltd. romanized |
| 2022/10/09New drug · Class 1 | BGM0504注射液 · No verified English nameCXHL2200761 | Bo Rui Xin Chuang Biopharmaceuticals Technology (Wuxi) Co., Ltd. romanized |
| 2022/10/09New drug · Class 1 | CTS2016胶囊 · No verified English nameCXHL2200760 | Sai Lan Pharmaceuticals Technology (Shenzhen) Co., Ltd. romanized |
| 2022/10/09New drug · Class 1 | CTS2016胶囊 · No verified English nameCXHL2200759 | Sai Lan Pharmaceuticals Technology (Shenzhen) Co., Ltd. romanized |
| 2022/10/09New drug · Class 1 | 氟[18F]纤抑素注射液 · No verified English nameCXHL2200758 | Yan Tai Lan Na Cheng Bio Technology Co., Ltd. romanized |
| 2022/10/09New drug · Class 1 | FZ002-037胶囊 · No verified English nameCXHL2200757 | Guangzhou Fei Mi Zi Technology Co., Ltd. romanized |
| 2022/10/09New drug · Class 1 | FZ002-037胶囊 · No verified English nameCXHL2200756 | Guangzhou Fei Mi Zi Technology Co., Ltd. romanized |
| 2022/10/08Generic · Class 3 | Cilostazol TabletsCYHS2201667 | Chengdu Brilliant Pharmaceutical Co., Ltd. |
| 2022/10/08Generic · Class 3 | Methocarbamol InjectionCYHS2201665 | Zhejiang Mei Di Shen Biopharmaceuticals Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2022/10/08New drug · Class 2.2; 2.4 | 盐酸右美托咪定鼻喷雾剂 · No verified English nameCXHS2200051 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2022/10/08New drug · Class 2.2; 2.4 | 盐酸右美托咪定鼻喷雾剂 · No verified English nameCXHS2200050 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2022/10/08New drug · Class 1 | SPH4336片 · No verified English nameCXHL2200755 | Shanghai Pharmaceuticals Group Co., Ltd. romanized |
| 2022/10/08New drug · Class 1 | HN0190片 · No verified English nameCXHL2200754 | Hui Nuo Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized; Nanjing Ming De Xin Yao Research and Development Co., Ltd. romanized |
| 2022/10/08New drug · Class 1 | HN0190片 · No verified English nameCXHL2200753 | Hui Nuo Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized; Nanjing Ming De Xin Yao Research and Development 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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