YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 185 drug applications between 10 May 2022 and 16 May 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 25, covering 19 drug names.
2022/05/10 – 2022/05/16
- New acceptances this week
- 185
- Drugs with new generic filings (by drug name, de-duplicated)
- 19
- 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
185filings, 25 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 104 |
| Generic | 25 |
| New drug | 24 |
| Import | 14 |
| Import re-registration | 12 |
| Unspecified | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 153 |
| TCM | 15 |
| Therapeutic biologic | 13 |
| Prophylactic 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
19 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 中/长链脂肪乳注射液(C6~24) · No verified English name | 2 | 1 | 0 |
| 2 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English name | 2 | 1 | 2 |
| 3 | Calcium Gluconate in Sodium Chloride Injection | 2 | 1 | 5 |
| 4 | Dapagliflozin Tablets | 2 | 1 | 84 |
| 5 | Timolol Maleate Eye Drops | 2 | 1 | 4 |
| 6 | Asenapine Maleate Sublingual Tablets | 2 | 1 | 1 |
| 7 | Diacerein Capsules | 1 | 1 | 3 |
| 8 | Desonide Cream | 1 | 1 | 0 |
| 9 | Celecoxib Capsules | 1 | 1 | 5 |
| 10 | Ornidazole Tablets | 1 | 1 | 0 |
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
99 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Henan Fu Ren Huai Qing Tang Pharmaceutical Co., Ltd. romanized | 19 | 17 | 0 |
| 2 | N.V. Organon | 8 | 1 | 0 |
| 3 | Pfizer Inc. | 4 | 3 | 0 |
| 4 | Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized | 4 | 3 | 0 |
| 5 | Shandong Qidu Pharmaceutical Co., Ltd. | 4 | 3 | 0 |
| 6 | Meiji Seika Pharma Co. Ltd. | 4 | 1 | 0 |
| 7 | Ling Ke Pharma (Hangzhou) Co., Ltd. romanized | 4 | 1 | 0 |
| 8 | Sichuan He Xin Pharma Co., Ltd. romanized | 4 | 1 | 0 |
| 9 | Zhejiang Jin Fang Pharma Co., Ltd. romanized | 4 | 1 | 0 |
| 10 | Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized | 3 | 3 | 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
48 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/05/13Import · Class 1 | Linzagolix片 · No verified English nameJXHL2200113 | Kissei Pharmaceutical Co. Ltd.; Bio Genuine (Shanghai) Biotech Co. Ltd. |
| 2022/05/13Import · Class 1 | Linzagolix片 · No verified English nameJXHL2200112 | Kissei Pharmaceutical Co. Ltd.; Bio Genuine (Shanghai) Biotech Co. Ltd. |
| 2022/05/13Generic · Class 3 | Norepinephrine Bitartrate InjectionCYHS2200733 | Chengdu Shuo De Pharma Co., Ltd. romanized |
| 2022/05/13New drug · Class 3.3 | ACYW135群脑膜炎球菌多糖结合疫苗 · No verified English nameCXSL2200213 | Liaoning Cheng Da Bio Co., Ltd. romanized; Beijing Cheng Da Tian He Bio Technology Co., Ltd. romanized; Cheng Da Bio (Ben Xi) Co., Ltd. romanized |
| 2022/05/13New drug · Class 2.4 | 盐酸米托蒽醌脂质体注射液 · No verified English nameCXHL2200307 | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD. |
| 2022/05/12Import · Class 1 | PF-07104091片 · No verified English nameJXHL2200111 | Pfizer Inc.; Pfizer Investment CO. Ltd |
| 2022/05/12Import · Class 1 | PF-07104091片 · No verified English nameJXHL2200110 | Pfizer Inc.; Pfizer Investment CO. Ltd |
| 2022/05/12Import · Class 1 | Liafensine片 · No verified English nameJXHL2200109 | Denovo Biopharma LLC; Denovo Biopharma Co. Ltd. |
| 2022/05/12Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2200731 | Fu Ou Pharmaceuticals Technology (Hu Zhou) Co., Ltd. romanized; Zhejiang Kai Run Pharma Co., Ltd. romanized |
| 2022/05/12New drug · Class 1 | CM310重组人源化单克隆抗体注射液 · No verified English nameCXSL2200212 | Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized |
| 2022/05/12New drug · Class 1 | GFH018 片 · No verified English nameCXHL2200306 | Zhejiang Jin Fang Pharma Co., Ltd. romanized |
| 2022/05/12New drug · Class 1 | GFH018 片 · No verified English nameCXHL2200305 | Zhejiang Jin Fang Pharma Co., Ltd. romanized |
| 2022/05/12New drug · Class 1 | GFH018 片 · No verified English nameCXHL2200304 | Zhejiang Jin Fang Pharma Co., Ltd. romanized |
| 2022/05/12New drug · Class 1 | GFH018 片 · No verified English nameCXHL2200303 | Zhejiang Jin Fang Pharma Co., Ltd. romanized |
| 2022/05/11Import · Class 1 | Cotadutide注射液 · No verified English nameJXHL2200108 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2022/05/11Import · Class 1 | Cotadutide注射液 · No verified English nameJXHL2200107 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2022/05/11Generic · Class 3 | Fudosteine oral solutionCYHS2200723 | Jiangsu Zheng Da Feng Hai Pharmaceutical Co., Ltd. romanized; Jiangsu Ou Ge Pharmaceutical Co., Ltd. romanized |
| 2022/05/11Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2200722 | HUNAN WARRANT PHARMACEUTICAL CO.,LTD |
| 2022/05/11Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2200721 | HUNAN WARRANT PHARMACEUTICAL CO.,LTD |
| 2022/05/11New drug · Class 1 | 注射用ZB001 · No verified English nameCXSL2200210 | Shanghai Ze Na Shi Bio Technology Co., Ltd. romanized |
| 2022/05/11New drug · Class 2.2 | 盐酸多奈哌齐口腔速溶膜 · No verified English nameCXHL2200300 | Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2022/05/11New drug · Class 2.2 | 盐酸多奈哌齐口腔速溶膜 · No verified English nameCXHL2200299 | Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2022/05/10Import · Class 2.2 | 度伐利尤单抗注射液 · No verified English nameJXSL2200057 | MedImmune LLC; AstraZeneca Investment (China) Co. Limited |
| 2022/05/10Import · Class 1 | Ponsegromab 注射液 · No verified English nameJXSL2200056 | Pfizer Inc.; Pfizer Investment CO. Ltd |
| 2022/05/10Import · Class 1 | AB-729注射液 · No verified English nameJXHL2200106 | Arbutus Biopharma Corporation; QILU PHARMACEUTICAL CO. LTD. |
| 2022/05/10Import · Class 1 | AB-729注射液 · No verified English nameJXHL2200105 | Arbutus Biopharma Corporation; QILU PHARMACEUTICAL CO. LTD. |
| 2022/05/10Generic · Class 3 | Ornidazole TabletsCYHS2200719 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2022/05/10Generic · Class 3 | Desonide CreamCYHS2200717 | Chongqing Hua Bang Sheng Kai Pharmaceutical Co., Ltd. romanized; Chongqing Huapont Pharmaceutical Co., Ltd. |
| 2022/05/10Generic · Class 3 | Calcium Gluconate in Sodium Chloride InjectionCYHS2200716 | Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2022/05/10Generic · Class 3 | Calcium Gluconate in Sodium Chloride InjectionCYHS2200715 | Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
18 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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