YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 241 drug applications between 11 February 2022 and 17 February 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 48, covering 35 drug names.
2022/02/11 – 2022/02/17
- New acceptances this week
- 241
- Drugs with new generic filings (by drug name, de-duplicated)
- 35
- 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
241filings, 48 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 138 |
| Generic | 48 |
| New drug | 39 |
| Import | 12 |
| Unspecified | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 171 |
| Therapeutic biologic | 48 |
| TCM | 21 |
| Prophylactic biologic | 1 |
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 | Sodium Hyaluronate Eye Drops | 3 | 3 | 30 |
| 2 | Regorafenib Tablets | 2 | 2 | 3 |
| 3 | Cinacalcet Hydrochloride Tablets | 2 | 2 | 2 |
| 4 | Nintedanib Esilate Soft Capsules | 2 | 1 | 6 |
| 5 | Etoricoxib Tablets | 2 | 1 | 8 |
| 6 | 利奈唑胺干混悬剂 · No verified English name | 2 | 1 | 1 |
| 7 | 注射用头孢西丁钠/氯化钠注射液 · No verified English name | 2 | 1 | 0 |
| 8 | Rosuvastatin Calcium Tablets | 2 | 1 | 18 |
| 9 | Memantine Hydrochloride Tablets | 2 | 1 | 2 |
| 10 | Oxytocin Injection | 2 | 1 | 8 |
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
152 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Guangxi Zhuang Zu Zi Zhi Qu Hua Hong Jin Rui Pharma Co., Ltd. romanized | 10 | 8 | 0 |
| 2 | Changchun Jin Sai Pharma Co., Ltd. romanized | 8 | 2 | 0 |
| 3 | AstraZeneca UK Limited | 6 | 2 | 0 |
| 4 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized | 6 | 1 | 0 |
| 5 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized | 5 | 2 | 0 |
| 6 | Sanofi-Aventis Deutschland GmbH | 4 | 4 | 0 |
| 7 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 4 | 2 | 0 |
| 8 | Alembic Pharmaceuticals Limited | 4 | 1 | 0 |
| 9 | UCB Pharma S.A. | 3 | 2 | 0 |
| 10 | CSPC OUYI PHARMACEUTICAL CO., LTD. | 3 | 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
55 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/02/17Import · Class 1 | Olvi-Vec注射液 · No verified English nameJXSL2200019 | Genelux Corporation; Newsoara Biopharma Co. Ltd. |
| 2022/02/17Import · Class 2.2 | 注射用Belantamab mafodotin · No verified English nameJXSL2200018 | GlaxoSmithKline (Ireland) Limited; GlaxoSmithKline (China) Investment Co. Limited |
| 2022/02/17Generic · Class 3 | 注射用头孢西丁钠/氯化钠注射液 · No verified English nameCYHS2200336 | Beijing Rui Ye Pharmaceutical Co., Ltd. romanized |
| 2022/02/17Generic · Class 3 | 注射用头孢西丁钠/氯化钠注射液 · No verified English nameCYHS2200335 | Beijing Rui Ye Pharmaceutical Co., Ltd. romanized |
| 2022/02/17Generic · Class 3 | Calcium Polycarbophil Fine GranulesCYHS2200334 | Suzhou Zhong Hua Medicines Gong Ye Co., Ltd. romanized |
| 2022/02/17Generic · Class 3 | Phenylephrine Hydrochloride InjectionCYHS2200329 | Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized |
| 2022/02/17Generic · Class 3 | Citicoline Sodium InjectionCYHS2200323 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2022/02/17New drug · Class 3.3 | 注射用曲妥珠单抗 · No verified English nameCXSS2200015 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2022/02/17New drug · Class 1 | DB-1202注射液 · No verified English nameCXSL2200095 | Ying En Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2022/02/17New drug · Class 1 | PM8002注射液 · No verified English nameCXSL2200094 | Pu Mi Si Bio Technology (Zhuhai) Co., Ltd. romanized |
| 2022/02/17New drug · Class 1 | R01散 · No verified English nameCXHL2200099 | Beijing An Jian Xi Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/02/17New drug · Class 1 | TT-01488片 · No verified English nameCXHL2200092 | Yao Jie An Kang (Nanjing) Technology Co., Ltd. romanized |
| 2022/02/16New drug · Class 2.3 | 大株红景天胶囊 · No verified English nameCXZL2200010 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized |
| 2022/02/16New drug · Class 1 | EVER001胶囊 · No verified English nameCXHL2200098 | Yun Ding Xin Yao Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/02/16New drug · Class 1 | SR750片 · No verified English nameCXHL2200095 | Shanghai Sai Mo Luo De Bio Technology Co., Ltd. romanized |
| 2022/02/16New drug · Class 1 | SR750片 · No verified English nameCXHL2200094 | Shanghai Sai Mo Luo De Bio Technology Co., Ltd. romanized |
| 2022/02/15Generic · Class 3 | Ambroxol Hydrochloride Oral SolutionCYHS2200305 | Anhui Yong Sheng Tang Pharma Co., Ltd. romanized |
| 2022/02/15New drug · Class 2.3 | 金振口服液 · No verified English nameCXZL2200009 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized |
| 2022/02/15New drug · Class 1 | 人源TH-SC01细胞注射液 · No verified English nameCXSL2200093 | Jiangsu Tuo Hong Kang Heng Pharmaceuticals Co., Ltd. romanized |
| 2022/02/15New drug · Class 1 | CPD-002注射液 · No verified English nameCXSL2200092 | Jiangxi Long Chang Pharma Co., Ltd. romanized |
| 2022/02/15New drug · Class 1 | 注射用8MW2311 · No verified English nameCXSL2200091 | Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized |
| 2022/02/15New drug · Class 1 | SYHX2005 · No verified English nameCXHL2200097 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2022/02/15New drug · Class 1 | SYHX2005 · No verified English nameCXHL2200096 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2022/02/15New drug · Class 1 | XTR006注射液 · No verified English nameCXHL2200090 | Beijing Xian Tong International Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/02/15New drug · Class 1 | BEBT-305片 · No verified English nameCXHL2200089 | Guangzhou Bi Bei Te Pharmaceuticals Co., Ltd. romanized |
| 2022/02/15New drug · Class 1 | BEBT-305片 · No verified English nameCXHL2200088 | Guangzhou Bi Bei Te Pharmaceuticals Co., Ltd. romanized |
| 2022/02/14Generic · Class 3 | 利奈唑胺干混悬剂 · No verified English nameCYHS2200309 | Zhejiang Pu Li Pharma Co., Ltd. romanized |
| 2022/02/14Generic · Class 3 | 利奈唑胺干混悬剂 · No verified English nameCYHS2200308 | Zhejiang Pu Li Pharma Co., Ltd. romanized |
| 2022/02/14Generic · Class 3 | Pregabalin Extended release TabletsCYHL2200017 | Beijing Tai De Pharmaceutical Co., Ltd. romanized |
| 2022/02/14New drug · Class 1 | 异体内皮祖细胞(EPCs)注射液 · No verified English nameCXSL2200090 | Cheng Nuo Zai Sheng Yi Xue Technology (Zhuhai Heng Qin Xin Qu) Co., Ltd. romanized |
25 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.
Subscribe to the weekly
No account needed.
The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.