YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 105 drug applications between 29 April 2022 and 5 May 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 12, covering 11 drug names.
2022/04/29 – 2022/05/05
- New acceptances this week
- 105
- Drugs with new generic filings (by drug name, de-duplicated)
- 11
- 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
105filings, 12 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 53 |
| New drug | 25 |
| Generic | 12 |
| Import | 12 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 70 |
| TCM | 20 |
| Therapeutic biologic | 11 |
| 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
11 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Nifedipine Controlled-release Tablets | 2 | 2 | 7 |
| 2 | Ipratropium Bromide Inhalation Solution | 1 | 1 | 2 |
| 3 | Ibuprofen Injection | 1 | 1 | 8 |
| 4 | Tinidazole Tablets | 1 | 1 | 0 |
| 5 | 氧(液态) · No verified English name | 1 | 1 | 13 |
| 6 | Piperacillin Sodium for Injection | 1 | 1 | 16 |
| 7 | Roxatidine Acetate Hydrochloride For Injection | 1 | 1 | 5 |
| 8 | Doxorubicin Hydrochloride Liposome Injection | 1 | 1 | 2 |
| 9 | Sitagliptin Phosphate Tablets | 1 | 1 | 2 |
| 10 | Roxithromycin Tablets | 1 | 1 | 2 |
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
65 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | UNION therapeutics A/S | 6 | 2 | 0 |
| 2 | Henan Tai Long Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 3 | Jilin Zhen Yuan Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 4 | Beijing Ke Xing Bio Zhi Pin Co., Ltd. romanized | 4 | 2 | 0 |
| 5 | MINGHUI PHARMACEUTICAL PTY LTD | 4 | 1 | 0 |
| 6 | Xiamen Te Bao Bio Gong Cheng Co., Ltd. romanized | 4 | 1 | 0 |
| 7 | Le Pu Pharma Co., Ltd. romanized | 3 | 1 | 0 |
| 8 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 3 | 1 | 0 |
| 9 | Beijing Hui Bao Yuan Bio Technology Co., Ltd. romanized | 2 | 2 | 0 |
| 10 | Beijing Lang Di Pharmaceutical Co., Ltd. romanized | 2 | 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
40 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/05/05Import · Class 1 | Orismilast 缓释片 · No verified English nameJXHL2200100 | UNION therapeutics A/S; Innovent Biologics (Suzhou) Co. Ltd. |
| 2022/05/05Import · Class 1 | Orismilast缓释片 · No verified English nameJXHL2200099 | UNION therapeutics A/S; Innovent Biologics (Suzhou) Co. Ltd. |
| 2022/05/05Import · Class 1 | Orismilast缓释片 · No verified English nameJXHL2200098 | UNION therapeutics A/S; Innovent Biologics (Suzhou) Co. Ltd. |
| 2022/05/05Import · Class 1 | Orismilast 缓释片 · No verified English nameJXHL2200097 | UNION therapeutics A/S; Innovent Biologics (Suzhou) Co. Ltd. |
| 2022/05/05Import · Class 1 | Orismilast缓释片 · No verified English nameJXHL2200096 | UNION therapeutics A/S; Innovent Biologics (Suzhou) Co. Ltd. |
| 2022/05/05Import · Class 1 | Orismilast缓释片 · No verified English nameJXHL2200095 | UNION therapeutics A/S; Innovent Biologics (Suzhou) Co. Ltd. |
| 2022/05/05Generic · Class 3 | Tinidazole TabletsCYHS2200698 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2022/05/05Generic · Class 3 | Roxatidine Acetate Hydrochloride For InjectionCYHS2200696 | Ke Bei Yuan (Beijing) Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized |
| 2022/05/05New drug · Class 1.1 | 参味宁郁片 · No verified English nameCXZS2200005 | Guangdong Si Ji Pharma Co., Ltd. romanized; Yi Li Pharmaceutical (Luo Ding) Co., Ltd. romanized |
| 2022/05/05New drug · Class 1 | GZR4 · No verified English nameCXSL2200192 | Gan Li Pharma Co., Ltd. romanized |
| 2022/05/05New drug · Class 1 | 培莫沙肽注射液 · No verified English nameCXHS2200022 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized |
| 2022/05/05New drug · Class 1 | 培莫沙肽注射液 · No verified English nameCXHS2200021 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized |
| 2022/05/05New drug · Class 1 | 培莫沙肽注射液 · No verified English nameCXHS2200020 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized |
| 2022/05/05New drug · Class 2.2; 2.4 | BM201注射液 · No verified English nameCXHL2200273 | Suzhou Bai Mai Biopharmaceuticals Co., Ltd. romanized |
| 2022/05/05New drug · Class 1 | HS248片 · No verified English nameCXHL2200272 | Han Hui Pharmaceutical Co., Ltd. romanized |
| 2022/05/05New drug · Class 1 | HS248片 · No verified English nameCXHL2200271 | Han Hui Pharmaceutical Co., Ltd. romanized |
| 2022/05/05New drug · Class 2.2 | 环孢素滴眼液 · No verified English nameCXHL2200262 | Zhuhai Yi Sheng Biopharmaceutical Co., Ltd. romanized |
| 2022/04/29Import · Class 1 | MH080乳膏 · No verified English nameJXHL2200094 | MINGHUI PHARMACEUTICAL PTY LTD; Minghui Pharmaceutical (Hangzhou) Ltd |
| 2022/04/29Import · Class 1 | MH080乳膏 · No verified English nameJXHL2200093 | MINGHUI PHARMACEUTICAL PTY LTD; Minghui Pharmaceutical (Hangzhou) Ltd |
| 2022/04/29Import · Class 1 | MH080乳膏 · No verified English nameJXHL2200092 | MINGHUI PHARMACEUTICAL PTY LTD; Minghui Pharmaceutical (Hangzhou) Ltd |
| 2022/04/29Import · Class 1 | MH080乳膏 · No verified English nameJXHL2200091 | MINGHUI PHARMACEUTICAL PTY LTD; Minghui Pharmaceutical (Hangzhou) Ltd |
| 2022/04/29Generic · Class 3 | Piperacillin Sodium for InjectionCYHS2200694 | Shandong Dao Qi Biopharmaceuticals Technology Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized |
| 2022/04/29Generic · Class 3 | Doxorubicin Hydrochloride Liposome InjectionCYHS2200689 | Zhejiang Sheng Zhao Drug Technology Co., Ltd. romanized; Zhejiang Hai Zheng Pharma Co., Ltd. romanized |
| 2022/04/29Generic · Class 3 | Ibuprofen InjectionCYHS2200644 | Chengdu Easton Biopharmaceuticals Co.,Ltd. |
| 2022/04/29New drug · Class 1.2 | 甘草总查耳酮胶囊 · No verified English nameCXZL2200021 | Beijing Hui Bao Yuan Bio Technology Co., Ltd. romanized |
| 2022/04/29New drug · Class 1.2 | 甘草总查耳酮 · No verified English nameCXZL2200020 | Beijing Hui Bao Yuan Bio Technology Co., Ltd. romanized |
| 2022/04/29New drug · Class 3.4 | 人凝血酶原复合物 · No verified English nameCXSS2200049 | Sichuan Yuan Da Shu Yang Pharma Co., Ltd. romanized |
| 2022/04/29New drug · Class 1 | 拓培非格司亭注射液 · No verified English nameCXSS2200048 | Xiamen Te Bao Bio Gong Cheng Co., Ltd. romanized |
| 2022/04/29New drug · Class 1 | 拓培非格司亭注射液 · No verified English nameCXSS2200047 | Xiamen Te Bao Bio Gong Cheng Co., Ltd. romanized |
| 2022/04/29New drug · Class 1 | 拓培非格司亭注射液 · No verified English nameCXSS2200046 | Xiamen Te Bao Bio Gong Cheng Co., Ltd. romanized |
10 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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