YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 255 drug applications between 25 May 2022 and 31 May 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 53, covering 35 drug names.
2022/05/25 – 2022/05/31
- New acceptances this week
- 255
- Drugs with new generic filings (by drug name, de-duplicated)
- 35
- 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
255filings, 53 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 116 |
| Generic | 53 |
| New drug | 46 |
| Import | 19 |
| Unspecified | 14 |
| Import re-registration | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 177 |
| Therapeutic biologic | 39 |
| TCM | 30 |
| Biologic | 7 |
| Prophylactic 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
35 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution | 3 | 2 | 23 |
| 2 | Palbociclib Capsules | 3 | 1 | 0 |
| 3 | 阿普米司特片 · No verified English name | 3 | 1 | 3 |
| 4 | Epalrestat Tablets | 2 | 2 | 1 |
| 5 | Tadalafil Tablets | 2 | 1 | 23 |
| 6 | Irbesartan and Amlodipine Tablets | 2 | 1 | 1 |
| 7 | Ornidazole Injection | 2 | 1 | 0 |
| 8 | Paliperidone Extend-release Tablets | 2 | 1 | 2 |
| 9 | Lamotrigine Dispersible Tablets | 2 | 1 | 2 |
| 10 | Dopamine Hydrochloride Injection | 2 | 1 | 3 |
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
153 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jiangxi Yuan Dong Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 2 | Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized | 5 | 4 | 0 |
| 3 | Novartis Pharma AG | 5 | 3 | 0 |
| 4 | Hainan Zan Bang Pharmaceutical Co., Ltd. romanized | 5 | 2 | 0 |
| 5 | ASPEN PHARMA TRADING LIMITED | 5 | 1 | 0 |
| 6 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 3 | 3 | 1 |
| 7 | Ren He Yi Kang Group Co., Ltd. romanized | 3 | 2 | 0 |
| 8 | Shenzhen Shi Wei Guang Bio Zhi Pin Co., Ltd. romanized | 3 | 2 | 0 |
| 9 | Suzhou Dong Rui Pharmaceutical Co., Ltd. romanized | 3 | 2 | 1 |
| 10 | Qilu Pharmaceutical (Hainan) Co., Ltd | 3 | 2 | 1 |
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
80 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/05/31Import · Class 2.4 | Ibrutinib CapsulesJXHS2200052 | Janssen-Cilag International NV; Catalent CTS LLC; Xian-Janssen Pharmaceutical Ltd. |
| 2022/05/31Generic · Class 3 | Calcium Gluconate in Sodium Chloride InjectionCYHS2200815 | Jiangsu Zheng Da Feng Hai Pharmaceutical Co., Ltd. romanized |
| 2022/05/31Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2200814 | Heilongjiang Zhong Gui Pharmaceutical Co., Ltd. romanized |
| 2022/05/31Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2200813 | Heilongjiang Zhong Gui Pharmaceutical Co., Ltd. romanized |
| 2022/05/31Generic · Class 3 | Citicoline Sodium InjectionCYHS2200806 | Jilin Zhen Ao Pharmaceutical Co., Ltd. romanized |
| 2022/05/31Generic · Class 3 | Citicoline Sodium InjectionCYHS2200805 | Jilin Zhen Ao Pharmaceutical Co., Ltd. romanized |
| 2022/05/31Generic · Class 3 | Ornidazole InjectionCYHS2200779 | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized |
| 2022/05/31Generic · Class 3 | Ornidazole InjectionCYHS2200778 | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized |
| 2022/05/31New drug · Class 2.3 | 前列闭尔通栓 · No verified English nameCXZL2200025 | Heilongjiang Sheng Ji Ren Pharma Co., Ltd. romanized |
| 2022/05/31New drug · Class 1 | 伊立珠单抗注射液 · No verified English nameCXSL2200237 | Bai Tai Bio Pharma Co., Ltd. romanized |
| 2022/05/31New drug · Class 1 | BRL-101自体造血干祖细胞注射液 · No verified English nameCXSL2200236 | Shanghai Bang Yao Bio Technology Co., Ltd. romanized |
| 2022/05/31New drug · Class 1 | IMB071703注射液 · No verified English nameCXSL2200235 | Beijing Mian Yi Fang Zhou Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/05/31New drug · Class 1 | 洛奈利单抗注射液 · No verified English nameCXSL2200228 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2022/05/31New drug · Class 1 | 注射用Zilovertamab vedotin · No verified English nameCXSL2200227 | Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized |
| 2022/05/31New drug · Class 2.2 | 醋酸阿比特龙片(Ⅰ) · No verified English nameCXHS2200030 | Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2022/05/31New drug · Class 1 | SAL0112片 · No verified English nameCXHL2200344 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2022/05/31New drug · Class 1 | SAL0112片 · No verified English nameCXHL2200343 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2022/05/31New drug · Class 1 | SAL0112片 · No verified English nameCXHL2200342 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2022/05/31New drug · Class 1 | 注射用Hemay181 · No verified English nameCXHL2200338 | Gan Zhou He Mei Pharma Co., Ltd. romanized |
| 2022/05/28Import · Class 3.1 | Netakimab注射液 · No verified English nameJXSL2200066 | Joint Stock Company “BIOCAD”,(JSC “BIOCAD”); SPH-Biocad Biopharmaceuticals (SH) Co. Ltd. |
| 2022/05/28Import · Class 2.2 | 二氟泼尼酯滴眼液 · No verified English nameJXHL2200123 | SUN PHARMACEUTICAL INDUSTRIES LTD. |
| 2022/05/28Import · Class 1 | Enpatoran · No verified English nameJXHL2200122 | Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd. |
| 2022/05/28Import · Class 1 | Enpatoran · No verified English nameJXHL2200121 | Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd. |
| 2022/05/28Generic · Class 3 | Epalrestat TabletsCYHS2200799 | Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2022/05/28New drug · Class 1 | 伊基仑赛注射液 · No verified English nameCXSL2200234 | Nanjing Xun Lu Biopharmaceuticals Co., Ltd. romanized |
| 2022/05/28New drug · Class 1 | 伊基仑赛注射液 · No verified English nameCXSL2200233 | Nanjing Xun Lu Biopharmaceuticals Co., Ltd. romanized |
| 2022/05/28New drug · Class 1 | EOC202注射液 · No verified English nameCXSL2200232 | Tai Zhou Yi Teng Jing Ang Pharma Co., Ltd. romanized |
| 2022/05/28New drug · Class 2.2 | 盐酸多奈哌齐口溶膜 · No verified English nameCXHL2200341 | Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/05/28New drug · Class 2.2 | Enzalutamide TabletsCXHL2200339 | Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized |
| 2022/05/27Import · Class 3.1 | 司美格鲁肽片 · No verified English nameJXSS2200018 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd. |
50 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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