YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 304 drug applications between 5 January 2022 and 11 January 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 48, covering 40 drug names.
2022/01/05 – 2022/01/11
- New acceptances this week
- 304
- Drugs with new generic filings (by drug name, de-duplicated)
- 40
- 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
304filings, 48 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 163 |
| Generic | 48 |
| New drug | 43 |
| Import | 33 |
| Unspecified | 9 |
| Import re-registration | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 207 |
| Therapeutic biologic | 51 |
| TCM | 40 |
| Biologic | 4 |
| 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
40 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Palbociclib Capsules | 3 | 1 | 0 |
| 2 | Latamoxef Sodium for Injection | 3 | 1 | 1 |
| 3 | 地氯雷他定口服溶液 · No verified English name | 2 | 2 | 26 |
| 4 | Octreotide Acetate Microspheres for Injection | 2 | 1 | 0 |
| 5 | Nalbuphine Hydrochloride Injection | 2 | 1 | 11 |
| 6 | Febuxostat Tablets | 2 | 1 | 12 |
| 7 | Lactulose Oral Solution | 1 | 1 | 34 |
| 8 | Voriconazole for Oral Suspension | 1 | 1 | 1 |
| 9 | Carbazochrome Sodium Sulfonate Injection | 1 | 1 | 1 |
| 10 | Irbesartan Tablets | 1 | 1 | 4 |
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
177 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hua Bei Pharmaceutical Group Xian Tai Pharma Co., Ltd. romanized | 17 | 4 | 0 |
| 2 | Haerbin Hong Dou Shan Biopharmaceutical Co., Ltd. romanized | 8 | 7 | 0 |
| 3 | Jiangxi Jiu Hua Pharma Co., Ltd. romanized | 7 | 3 | 0 |
| 4 | Henan Fu Ren Tang Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Hubei Rui Ze Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 6 | NewAmsterdam Pharma B.V. | 4 | 2 | 0 |
| 7 | Pfizer Europe MA EEIG | 4 | 2 | 0 |
| 8 | YaoPharma Co., Ltd. | 4 | 2 | 4 |
| 9 | Fresenius Kabi AB | 4 | 1 | 0 |
| 10 | Nian Yan Pharma (Zhuhai) Co., Ltd. romanized | 4 | 1 | 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
84 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/01/11Generic · Class 3 | Nalbuphine Hydrochloride InjectionCYHS2200043 | Chengdu Easton Biopharmaceuticals Co.,Ltd. |
| 2022/01/11Generic · Class 3 | Nalbuphine Hydrochloride InjectionCYHS2200042 | Chengdu Easton Biopharmaceuticals Co.,Ltd. |
| 2022/01/11Generic · Class 3 | Latamoxef Sodium for InjectionCYHS2200040 | Hainan Ling Kang Pharmaceutical Co., Ltd. romanized |
| 2022/01/11Generic · Class 3 | Latamoxef Sodium for InjectionCYHS2200039 | Hainan Ling Kang Pharmaceutical Co., Ltd. romanized |
| 2022/01/11Generic · Class 3 | Latamoxef Sodium for InjectionCYHS2200038 | Hainan Ling Kang Pharmaceutical Co., Ltd. romanized |
| 2022/01/11Generic · Class 3 | Levofloxacin InjectionCYHS2200036 | Shandong Hua Lu Pharmaceutical Co., Ltd. romanized |
| 2022/01/11Generic · Class 3 | Timolol Maleate Eye DropsCYHS2200033 | Wuhan Wu Jing Pharmaceuticals Technology Co., Ltd. romanized; Wuhan Wu Jing Pharma Co., Ltd. romanized |
| 2022/01/11Generic · Class 3 | Gadobenate Dimeglumine InjectionCYHS2200032 | Hainan Brilliant Pharmaceutical Co., Ltd. |
| 2022/01/11Generic · Class 3 | Nimodipine Oral SolutionCYHS2200017 | Zhejiang Guo Jing Pharma Co., Ltd. romanized |
| 2022/01/11Generic · Class 3 | Fludrocortisone Acetate TabletsCYHS2102312 | Jiangsu Fu Xin Yu Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Wan He Pharmaceutical Co., Ltd. romanized |
| 2022/01/11Generic · Class 3 | Ambroxol Hydrochloride Solution For InhalationCYHL2200002 | Zhang Feng Pharma Co., Ltd. romanized |
| 2022/01/11New drug · Class 3.3 | 利妥昔单抗注射液 · No verified English nameCXSS2200002 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2022/01/11New drug · Class 1 | 泽贝妥单抗注射液 · No verified English nameCXSS2200001 | Zhejiang Bo Rui Biopharmaceutical Co., Ltd. romanized; Hai Zheng Biopharmaceutical Co., Ltd. romanized |
| 2022/01/11New drug · Class 1 | AK127注射液 · No verified English nameCXSL2200011 | Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized |
| 2022/01/11New drug · Class 1 | 伏罗尼布片 · No verified English nameCXHS2200003 | Bei Da Pharma Co., Ltd. romanized |
| 2022/01/11New drug · Class 2.2 | 阿立哌唑口溶膜 · No verified English nameCXHS2200002 | Li Pin Pharma (Xiamen) Co., Ltd. romanized; Xiamen Li Zhuo Pharma Co., Ltd. romanized |
| 2022/01/11New drug · Class 2.2 | 阿立哌唑口溶膜 · No verified English nameCXHS2200001 | Li Pin Pharma (Xiamen) Co., Ltd. romanized; Xiamen Li Zhuo Pharma Co., Ltd. romanized |
| 2022/01/11New drug · Class 1 | 注射用GNP · No verified English nameCXHL2200012 | Guangzhou Lei En Kang Ya Biopharmaceuticals Technology Co., Ltd. romanized |
| 2022/01/11New drug · Class 1 | 注射用HSK36273 · No verified English nameCXHL2200011 | Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized |
| 2022/01/11New drug · Class 1 | 盐酸安舒法辛缓释片 · No verified English nameCXHL2200010 | Shandong Lv Ye Pharmaceutical Co., Ltd. romanized |
| 2022/01/11New drug · Class 1 | 盐酸安舒法辛缓释片 · No verified English nameCXHL2200009 | Shandong Lv Ye Pharmaceutical Co., Ltd. romanized |
| 2022/01/10Import · Class 2.4 | Baricitinib TabletsJXHS2200004 | Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; Lilly Suzhou Pharmaceutical Co. Ltd |
| 2022/01/10Import · Class 2.4 | Baricitinib TabletsJXHS2200003 | Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; Lilly Suzhou Pharmaceutical Co. Ltd |
| 2022/01/10Generic · Class 3 | Digoxin InjectionCYHS2200029 | Lang Tian Pharma (Hubei) Co., Ltd. romanized |
| 2022/01/10Generic · Class 3 | 盐酸溴已新注射液 · No verified English nameCYHS2200026 | Jilin Si Zhang Pharmaceutical Co., Ltd. romanized |
| 2022/01/10Generic · Class 3 | Carbazochrome Sodium Sulfonate InjectionCYHS2200024 | Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2022/01/10Generic · Class 3 | Desmopressin Acetate Oral SolutionCYHS2200023 | Nanjing Healthnice Pharmaceutical Technology Co., Ltd; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2022/01/10Generic · Class 3 | Obeticholic Acid TabletsCYHL2200001 | China Resources Sanjiu Medical & Pharmaceutical Co.,Ltd. |
| 2022/01/10New drug · Class 1 | QX005N注射液 · No verified English nameCXSL2200010 | Jiangsu Quan Xin Biopharmaceuticals Co., Ltd. romanized |
| 2022/01/10New drug · Class 1 | SSGJ-617注射液 · No verified English nameCXSL2200008 | San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized |
54 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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