YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 226 drug applications between 4 May 2022 and 10 May 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 30, covering 21 drug names.
2022/05/04 – 2022/05/10
- New acceptances this week
- 226
- Drugs with new generic filings (by drug name, de-duplicated)
- 21
- 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
226filings, 30 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 104 |
| New drug | 51 |
| Generic | 30 |
| Import | 21 |
| Import re-registration | 13 |
| Unspecified | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 154 |
| Therapeutic biologic | 36 |
| TCM | 29 |
| Prophylactic biologic | 7 |
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
21 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 奥氮平盐酸氟西汀胶囊 · No verified English name | 5 | 1 | 0 |
| 2 | Amisulpride Injection | 2 | 1 | 1 |
| 3 | Moxifloxacin Hydrochloride Eye Drops | 2 | 1 | 4 |
| 4 | Calcium Gluconate in Sodium Chloride Injection | 2 | 1 | 5 |
| 5 | Timolol Maleate Eye Drops | 2 | 1 | 4 |
| 6 | Asenapine Maleate Sublingual Tablets | 2 | 1 | 1 |
| 7 | Desonide Cream | 1 | 1 | 0 |
| 8 | Celecoxib Capsules | 1 | 1 | 5 |
| 9 | 复方聚乙二醇电解质散(Ⅲ) · No verified English name | 1 | 1 | 1 |
| 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
122 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | N.V. Organon | 12 | 2 | 0 |
| 2 | UNION therapeutics A/S | 6 | 2 | 0 |
| 3 | Chengdu Hong Ji Bio Technology Co., Ltd. romanized | 6 | 1 | 0 |
| 4 | Pfizer Inc. | 5 | 4 | 0 |
| 5 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 5 | 3 | 0 |
| 6 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 5 | 3 | 0 |
| 7 | Jiangsu Zhang Tai Pharma Co., Ltd. romanized | 5 | 1 | 5 |
| 8 | Jilin Zhen Yuan Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized | 4 | 3 | 0 |
| 10 | Astellas Pharma Europe B.V. | 4 | 2 | 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
88 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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 |
| 2022/05/10Generic · Class 3 | Timolol Maleate Eye DropsCYHS2200714 | Shijiazhuang Gree Pharmaceutical Co., Ltd |
| 2022/05/10Generic · Class 3 | Timolol Maleate Eye DropsCYHS2200713 | Shijiazhuang Gree Pharmaceutical Co., Ltd |
| 2022/05/10Generic · Class 3 | Asenapine Maleate Sublingual TabletsCYHL2200043 | HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. |
| 2022/05/10Generic · Class 3 | Asenapine Maleate Sublingual TabletsCYHL2200042 | HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. |
| 2022/05/10New drug · Class 1.1 | 清肺达原颗粒 · No verified English nameCXZL2200022 | Jin Pai Chi Zheng Tang Pharma Co., Ltd. romanized |
| 2022/05/10New drug · Class 3.4 | 人凝血酶原复合物 · No verified English nameCXSS2200050 | Guo Yao Group Lanzhou Biopharmaceutical Co., Ltd. romanized |
| 2022/05/10New drug · Class 1 | 注射用JS203 · No verified English nameCXSL2200211 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2022/05/10New drug · Class 1 | 注射用BL-M07D1 · No verified English nameCXSL2200209 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2022/05/10New drug · Class 2.2 | 盐酸氨溴索无水吞服颗粒 · No verified English nameCXHS2200023 | Shandong Ke Cheng Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Pharmaceuticals Group (Ben Xi) Bei Fang Pharma Co., Ltd. romanized |
| 2022/05/10New drug · Class 1 | APS03118胶囊 · No verified English nameCXHL2200298 | Beijing Zhi Jian Jin Rui Biopharmaceuticals Technology Co., Ltd. romanized |
| 2022/05/10New drug · Class 1 | APS03118胶囊 · No verified English nameCXHL2200297 | Beijing Zhi Jian Jin Rui Biopharmaceuticals Technology Co., Ltd. romanized |
| 2022/05/10New drug · Class 1 | 苹果酸Sitravatinib胶囊 · No verified English nameCXHL2200296 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2022/05/10New drug · Class 1 | LNK01004软膏 · No verified English nameCXHL2200295 | Ling Ke Pharma (Hangzhou) Co., Ltd. romanized |
| 2022/05/10New drug · Class 1 | LNK01004软膏 · No verified English nameCXHL2200294 | Ling Ke Pharma (Hangzhou) Co., Ltd. romanized |
| 2022/05/10New drug · Class 1 | LNK01004软膏 · No verified English nameCXHL2200293 | Ling Ke Pharma (Hangzhou) Co., Ltd. romanized |
| 2022/05/10New drug · Class 1 | LNK01004软膏 · No verified English nameCXHL2200292 | Ling Ke Pharma (Hangzhou) Co., Ltd. romanized |
| 2022/05/10New drug · Class 1 | 苹果酸Sitravatinib胶囊 · No verified English nameCXHL2200291 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2022/05/10New drug · Class 1 | WJ-39片 · No verified English nameCXHL2200287 | Ningxia Kang Ya Pharma Co., Ltd. romanized |
| 2022/05/07Import · Class 2.2 | 纳武利尤单抗注射液 · No verified English nameJXSL2200055 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2022/05/07Generic · Class 3 | 奥氮平盐酸氟西汀胶囊 · No verified English nameCYHS2200710 | Jiangsu Zhang Tai Pharma Co., Ltd. romanized |
| 2022/05/07Generic · Class 3 | 奥氮平盐酸氟西汀胶囊 · No verified English nameCYHS2200709 | Jiangsu Zhang Tai Pharma Co., Ltd. romanized |
| 2022/05/07Generic · Class 3 | 奥氮平盐酸氟西汀胶囊 · No verified English nameCYHS2200708 | Jiangsu Zhang Tai Pharma Co., Ltd. romanized |
58 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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